This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region (NCT00986102), a na phase 4 study. The primary outcome is Number of Participants With the Usage of Doripenem as Per the Approved Indication.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00986102 |
| Phase | Phase 4 |
| Condition | Pneumonia, Pneumonia, Ventilator-Associated, Urinary Tract Infections |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 216 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Janssen Research & Development, LLC |
| Results posted | Yes |
2. Clinical Question
Population
The record describes participants enrolled in a prospective study of doripenem use in the Asia Pacific region. Conditions listed include pneumonia, ventilator-associated pneumonia and urinary tract infections. The primary endpoint population is the intent-to-treat population, defined in the registry record as enrolled participants who received at least one dose of study medication. The record does not report the number in that endpoint population.
Intervention
The intervention was doripenem, described as a 500mg vial given by injection every 8 hours for 5 to 14 days. The study purpose was to understand doripenem utilization patterns, including the profile of patients treated with carbapenems. The record does not describe additional intervention groups.
Comparator
There was no randomized comparison: allocation is listed as NA, masking as none, and the model as single group. The registry record does not describe a control arm. Consequently, the design does not provide a like-for-like comparison of doripenem with another treatment or with no treatment.
Primary question
The primary measure concerns the number of participants whose doripenem use was per the approved indication, over a timeframe of 5 to 14 days. For nosocomial pneumonia and ventilator-associated pneumonia, the record defines early onset as less than 5 days after hospitalization and late onset as more than or equal to 5 days after hospitalization. The number meeting the primary measure is not reported in the registry record.
This is a utilization question rather than a randomized treatment-effect question. The primary measure is framed as a count of participants whose use met an approved-indication criterion. It can therefore describe use among the study population if a result is reported, but it does not by itself estimate how outcomes would differ under another treatment. The registry record also names secondary outcomes concerning clinical cure, clinical failure, relapse, intermediate outcomes, microbiological response, medical resource utilization and readmission. Results for those outcomes are not reported in the registry record.
3. Trial Design
The PROUD Study is listed as a prospective Phase 4 study of doripenem usage patterns in the Asia Pacific region. Its stated purpose was to understand how doripenem was used, including the profile of patients treated with carbapenems. The study is marked completed, with enrollment of 216. The recorded start date is 2009-07-17 and the primary completion date is 2011-09-05.
The design is described as single group, with allocation listed as NA and masking as none. These features mean the record does not describe randomized assignment or a masked comparison. It also does not describe a control group. The listed intervention is doripenem, specified as a 500mg vial by injection every 8 hours for 5 to 14 days. These details describe the intervention recorded, but the registry record does not report how treatment decisions were made for individual participants or whether actual treatment duration varied.
The primary outcome is a number of participants with doripenem use per the approved indication, with a timeframe of 5 to 14 days. The endpoint population is defined as the intent-to-treat population: all enrolled participants who received at least one dose of study medication. The record does not give the size of this population or the primary outcome count.
The registry lists pneumonia, ventilator-associated pneumonia and urinary tract infections among the conditions. Its secondary outcomes cover clinical and microbiological responses, resource utilization and readmissions. Safety data are also listed for nosocomial pneumonia, ventilator-associated pneumonia, complicated urinary tract infection and complicated intra-abdominal infection. The record does not explain how those safety groupings relate to the listed conditions or report group-specific enrollment details beyond the safety counts. Because the study has no randomized control group, the listed groups should not be treated as a randomized comparison.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 217 patients were enrolled and 216 received study medication. 1 patient was enrolled but subsequently withdrew consent before receiving the study medication. 61 patients discontinued study medication prior to end of treatment.
Overall Study
| Stage | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| STARTED | 53 | 77 | 19 | 67 |
| COMPLETED | 52 | 75 | 19 | 66 |
| NOT COMPLETED | 1 | 2 | 0 | 1 |
Reasons for not completing this period:
| Reason | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|
| Lost to Follow-up | 0 | 1 | 0 | 1 |
| Withdrawal by Subject | 1 | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population: Included all enrolled participants who received at least one dose of study medication.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 53 | 77 | 19 | 67 | 216 | |
| Age, Continuous | years | 54.1 (SD 17.52) | 44.4 (SD 19.17) | 58.2 (SD 13.23) | 49.2 (SD 16.13) | 49.5 (SD 17.88) |
| Sex: Female, Male: Female | Participants | 16 | 19 | 13 | 24 | 72 |
| Sex: Female, Male: Male | Participants | 37 | 58 | 6 | 43 | 144 |
| Race/Ethnicity, Customized: Chinese | Participants | 8 | 13 | 7 | 28 | 56 |
| Race/Ethnicity, Customized: Malay | Participants | 33 | 44 | 8 | 35 | 120 |
| Race/Ethnicity, Customized: Indian | Participants | 2 | 3 | 2 | 0 | 7 |
| Race/Ethnicity, Customized: Aboriginal | Participants | 0 | 0 | 0 | 1 | 1 |
| Race/Ethnicity, Customized: White | Participants | 0 | 1 | 0 | 1 | 2 |
| Race/Ethnicity, Customized: Others | Participants | 10 | 16 | 2 | 2 | 30 |
| Patient's location in the hospital upon enrollment: Intensive Care Unit (ICU) | Participants | 30 | 69 | 9 | 29 | 137 |
| Patient's location in the hospital upon enrollment: Non -ICU | Participants | 23 | 8 | 10 | 36 | 77 |
| Patient's location in the hospital upon enrollment: Missing | Participants | 0 | 0 | 0 | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With the Usage of Doripenem as Per the Approved Indication, measured over 5 to 14 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with doripenem use described as being per the approved indication. The recorded timeframe is 5 to 14 days, and the endpoint population is the intent-to-treat population, defined as enrolled participants who received at least one dose of study medication. The registry record does not report the endpoint count or the number of participants included in that population.
A count of participants meeting an indication criterion is intended to describe whether observed prescribing aligned with that criterion. It is a utilization measure, not a direct estimate of comparative treatment benefit. In a single-group study, such a count can describe the recorded pattern of use but cannot establish what would have happened under an alternative treatment strategy.
The endpoint description gives timing definitions for nosocomial pneumonia and ventilator-associated pneumonia: early onset is less than 5 days after hospitalization, and late onset is more than or equal to 5 days after hospitalization. Those definitions clarify how onset timing is categorized for the endpoint description. The registry record does not provide the operational details used to decide whether each participant's doripenem use met the approved indication, nor does it report a breakdown by early or late onset.
The registry also names clinical cure, clinical failure, intermediate outcome, relapse, microbiological response and other secondary measures. These could describe outcomes at end-of-treatment or test-of-cure visits, but their numerical results are not reported in the registry record. The primary measure should therefore be read as an endpoint definition, not as evidence of a particular observed level of appropriate use or a treatment effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a descriptive primary question: how many participants had doripenem use per the approved indication. Although enrollment is listed as 216, the record does not report the primary endpoint count, the number in the endpoint population, or a statistical estimate of the proportion or count meeting the criterion. The primary result therefore cannot be quantified from the registry record.
The study's single-group design is central to interpretation. With allocation listed as NA, masking as none and the model as single group, there is no randomized control arm described. The observations can characterize treatment use and recorded outcomes in the study population, but they cannot isolate the effect of doripenem from differences in patient characteristics, clinical decisions, disease course or other care. A comparison of separate condition groups, if one were made, would not become a randomized treatment comparison merely because the groups are listed separately.
Several secondary outcome definitions are recorded, including clinical cure, clinical failure, relapse, intermediate outcome, eradication and persistence. The registry record also names resource utilization and readmission within 28 days after end-of-treatment. These outcomes address different aspects of care and follow-up; they should not be conflated with the primary utilization endpoint. Their numerical results and any analysis estimates are not reported in the registry record.
Safety information is listed for four infection categories. Within each category, the record gives counts of serious and other adverse events and counts at risk. These are descriptive counts, not comparative treatment estimates. The registry does not provide a control group, a causal attribution analysis, or death counts. Listed serious adverse event terms have percentages, but their denominators and method of calculation are not reported in the registry record. Those percentages should not be read as a complete safety profile or as proof that doripenem caused the events.
The record lists 10 outcome measures and 0 analyses. The absence of reported analyses means there is no registry-reported inferential result to interpret, such as a confidence interval or hypothesis test for the primary endpoint. A confidence interval, in general, expresses the statistical uncertainty around an estimate under the assumptions of the analysis. Since no primary estimate or interval is reported, precision cannot be assessed. Likewise, a missing result should not be interpreted as a null finding; it indicates that the result is not reported in the registry record.
Overall, the registry record supports a description of the study's stated purpose, design, endpoint definitions and selected safety counts. It does not provide enough outcome information to quantify the primary endpoint or assess the precision of outcome estimates. It also cannot support a causal comparison between doripenem and another treatment.
9. Statistical Methods Explained
What does a single-group design allow?
In general, a single-group study observes participants receiving the intervention without a randomized control group. It can describe who was treated, how treatment was used and what outcomes were recorded in the observed group. It cannot by itself show what would have happened to comparable participants under another treatment. That missing counterfactual is why a descriptive count should not be interpreted as a comparative treatment effect.
For this study, the registry lists a single-group model, allocation as NA and masking as none. Those design descriptions do not establish a randomized comparator. Even if outcomes are reported for different infection categories, the categories are not identified as randomized arms. Differences between categories could reflect the characteristics of the conditions or participants rather than a treatment contrast.
What is a count endpoint?
In general, a count endpoint records how many participants meet a stated outcome definition. It is different from a continuous measurement, such as a laboratory value, and different from a time-to-event endpoint, which concerns when an event occurs. The primary outcome is explicitly described as a number of participants with use per the approved indication. The registry does not report that number, so there is no observed primary count to interpret or compare.
A count alone also needs context. A reader normally needs to know the population in which the count was assessed and how the endpoint was defined. The record defines the intent-to-treat population as enrolled participants who received at least one dose, and gives a timeframe of 5 to 14 days. It does not report the size of that endpoint population or further operational details for judging whether use was per the approved indication. No denominator-based estimate can therefore be recovered from the registry record without making an unsupported calculation.
How should the onset definitions be read?
The endpoint description classifies nosocomial pneumonia and ventilator-associated pneumonia as early onset when they occur less than 5 days after hospitalization, and late onset when they occur more than or equal to 5 days after hospitalization. These are classification boundaries, not observed study results. The registry does not report counts in either onset category or an analysis comparing them. More generally, a definition helps establish which observations belong in an endpoint, but it does not show how many participants met that definition.
What does uncertainty mean?
In general, a confidence interval gives a range of values compatible with an estimate under a specified statistical model and sampling assumptions. A narrower interval indicates greater statistical precision, while a wider interval indicates greater uncertainty. It does not address every source of uncertainty, such as bias from selection or measurement. No primary estimate or confidence interval is reported in the registry record, so its statistical precision cannot be judged.
In general, a hypothesis test evaluates compatibility between data and a specified null hypothesis under an analysis plan. A p-value is not the probability that a treatment works, and it does not describe the size or clinical importance of an effect. The record lists 0 analyses and does not report a primary test or p-value. No inferential conclusion can therefore be drawn from a reported test result.
Why does the lack of a comparator matter?
General statistical interpretation of treatment effects depends on a valid comparison that accounts for how groups came to receive different treatments. Randomization can support comparability on average, though it does not guarantee that every measured feature is identical. Here, the registry does not describe random allocation or a control group. Thus, the recorded counts can be used descriptively, but they do not estimate a randomized contrast. Differences from external expectations or other studies would also require comparable populations, definitions and follow-up; such a comparison is not reported in the registry record.
How should planning illustrations be understood?
In general, sample-size planning asks how many participants a future study might need under chosen assumptions about an effect, significance level, allocation and statistical model. A planning calculation is conditional on those assumptions; it is not an observed result and does not show the actual probability that a completed study detected an effect. The record's planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation and effects expressed as fractions of an observed effect. It also says that planning illustrations are based on the observed effect, not the trial's own design.
That planning description should not be mistaken for this study's design: the registry describes the study as single group and does not provide a like-for-like randomized comparison. No calculated planning values or observed primary effect are reported in the registry record. Consequently, there is no basis to state an achieved power or to interpret any planning illustration as an observed trial finding. Sample-size calculations, in general, are planning aids, not substitutes for estimates and uncertainty from the completed study.
What does over-dispersion mean in general?
For count data, a statistical model may assume that the variability is related to the average count in a particular way. Over-dispersion means the observed variability is greater than that model assumes. If it is ignored, standard errors can be too small and confidence intervals too narrow. This is a general concern for some count analyses, not a reported issue in this study: the registry record does not describe a count model, an over-dispersion assessment or a statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 10 outcome measures and 0 analyses. It names a primary outcome and several secondary outcomes, including clinical cure, clinical failure, intermediate outcome, relapse, microbiological response, resource utilization and readmission. However, it does not report a statistical analysis plan describing how those outcomes were analyzed or whether any adjustment for multiple testing was planned.
In general, when many outcomes or statistical tests are examined, the chance of at least one apparently notable finding can increase. A prespecified hierarchy or multiplicity adjustment can help control that risk, depending on the study's objectives. The registry record does not say whether such methods were used. Since no analyses are listed, there are no reported hypothesis tests to assess for multiplicity.
Missing outcome results also limit interpretation. The primary endpoint definition and population are described, but the endpoint count and endpoint population size are not reported in the registry record. Secondary outcome definitions are listed without numerical results. The record does not explain whether missing outcome data occurred, how such data were handled, or whether any sensitivity analyses were conducted. Those matters are not reported in the registry record.
The defined intent-to-treat population includes enrolled participants who received at least one dose of study medication. The record does not report the number in that population, whether other analysis populations were used, or how participants with incomplete assessments were handled. The overall enrollment figure should not be treated as the endpoint denominator because the record does not state that all enrolled participants received a dose or contributed data to every outcome. Without a reported denominator and missing-data approach, completeness and potential bias cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Nosocomial Pneumonia (NP) | 22 | 53 | 41.5% |
| Ventilator-Associated Pneumonia (VAP) | 24 | 77 | 31.2% |
| Complicated Urinary Tract Infection (cUTI) | 3 | 19 | 15.8% |
| Complicated Intra-abdominal Infection (cIAI) | 15 | 67 | 22.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Nosocomial Pneumonia (NP) | 27 of 53 |
| Ventilator-Associated Pneumonia (VAP) | 38 of 77 |
| Complicated Urinary Tract Infection (cUTI) | 11 of 19 |
| Complicated Intra-abdominal Infection (cIAI) | 32 of 67 |
Most frequent serious adverse event terms
| Event term | Organ system | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | 5 of 53 | 4 of 77 | 1 of 19 | 4 of 67 |
| Septic Shock | Infections and infestations | 6 of 53 | 4 of 77 | 1 of 19 | 1 of 67 |
| Sepsis | Infections and infestations | 2 of 53 | 3 of 77 | 0 of 19 | 5 of 67 |
| Acute Coronary Syndrome | Cardiac disorders | 1 of 53 | 1 of 77 | 0 of 19 | 2 of 67 |
| Renal Failure Acute | Renal and urinary disorders | 2 of 53 | 1 of 77 | 0 of 19 | 1 of 67 |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 2 of 53 | 2 of 77 | 0 of 19 | 0 of 67 |
| Acute Myocardial Infarction | Cardiac disorders | 0 of 53 | 2 of 77 | 0 of 19 | 0 of 67 |
| Bradycardia | Cardiac disorders | 0 of 53 | 2 of 77 | 0 of 19 | 0 of 67 |
| Multi-Organ Failure | General disorders | 0 of 53 | 1 of 77 | 0 of 19 | 1 of 67 |
| Urinary Tract Infection | Infections and infestations | 1 of 53 | 1 of 77 | 0 of 19 | 0 of 67 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Nosocomial Pneumonia (NP) | Ventilator-Associated Pneumonia (VAP) | Complicated Urinary Tract Infection (cUTI) | Complicated Intra-abdominal Infection (cIAI) |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 3 of 53 | 4 of 77 | 1 of 19 | 3 of 67 |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | 4 of 53 | 5 of 77 | 0 of 19 | 0 of 67 |
| Thrombophlebitis | Vascular disorders | 3 of 53 | 1 of 77 | 4 of 19 | 1 of 67 |
| Pneumonia | Infections and infestations | 1 of 53 | 4 of 77 | 2 of 19 | 1 of 67 |
| Alanine Aminotransferase Increased | Investigations | 4 of 53 | 3 of 77 | 0 of 19 | 1 of 67 |
| Blood Alkaline Phosphatase Increased | Investigations | 5 of 53 | 2 of 77 | 1 of 19 | 0 of 67 |
| Hypokalaemia | Metabolism and nutrition disorders | 4 of 53 | 2 of 77 | 1 of 19 | 1 of 67 |
| Diarrhoea | Gastrointestinal disorders | 1 of 53 | 2 of 77 | 1 of 19 | 2 of 67 |
| Gamma-Glutamyltransferase Increased | Investigations | 5 of 53 | 0 of 77 | 0 of 19 | 1 of 67 |
| Hypertension | Vascular disorders | 0 of 53 | 1 of 77 | 0 of 19 | 5 of 67 |
Serious events with the highest arm-level rate: septic shock (11.3%), pneumonia (9.4%), sepsis (7.5%), pyelonephritis (5.3%), convulsion (3.8%).
The registry lists serious and other adverse event counts for nosocomial pneumonia, ventilator-associated pneumonia, complicated urinary tract infection and complicated intra-abdominal infection. For nosocomial pneumonia, the listed serious-event count is 22 among 53 at risk, and the other-event count is 27 among 53 at risk. For ventilator-associated pneumonia, the counts are 24 among 77 at risk for serious events and 38 among 77 at risk for other events.
For complicated urinary tract infection, the registry lists 3 serious events among 19 at risk and 11 other events among 19 at risk. For complicated intra-abdominal infection, it lists 15 serious events among 67 at risk and 32 other events among 67 at risk. These are counts as recorded; they are not newly calculated rates. The record does not explain whether participants could contribute more than one event or how the event categories were defined.
The listed serious adverse event terms include septic shock at 11.3%, pneumonia at 9.4%, sepsis at 7.5%, pyelonephritis at 5.3%, convulsion at 3.8% and acute renal failure at 3.8%. The denominator and calculation method for these percentages are not reported in the registry record. Death counts are not reported in the registry record.
These data are descriptive. There is no randomized control group in the registry record, and the counts alone do not establish that doripenem caused an event or allow comparison with another treatment. They also do not constitute a complete account of safety beyond the listed categories and terms.
12. What the Result Does, and Does Not, Mean
The study's stated purpose was to describe doripenem utilization patterns in the Asia Pacific region, including the profile of patients treated with carbapenems. Its primary measure asks for the number of participants whose use was per the approved indication. That framing is relevant to understanding prescribing practice, but the registry record does not report the primary count or the size of the endpoint population. It therefore does not show the observed level of use meeting the criterion.
The registry describes a prospective Phase 4 study with a single-group design, no masking and allocation listed as NA. Those details define the kind of evidence available: the study can describe use and recorded outcomes in its study population, but it does not provide a randomized comparison. The outcome definitions for clinical cure, clinical failure, relapse, intermediate outcome and microbiological response indicate the kinds of secondary questions considered. Their results are not reported in the registry record.
The record also lists selected adverse event counts and serious adverse event terms. These entries can convey which counts and terms were recorded, but they do not establish causal attribution, comparative risk or the full safety experience. Denominators for the listed serious-event-term percentages are not reported, and death counts are not reported in the registry record.
What the record does not establish is as important as what it describes. It does not provide an estimate of the primary outcome, uncertainty around that estimate, or a statistical test. It does not report a comparator group, so it cannot show whether outcomes differed from those under another treatment. A missing result is not evidence that the outcome did not occur or that there was no effect; it means the result is not reported in the registry record.
In general, a descriptive utilization study can contribute information about treatment patterns and the outcomes recorded in a defined setting. Its usefulness depends on clear population and outcome definitions, complete reporting and an appropriately cautious interpretation. Here, the registry supplies some design and endpoint definitions, but not the primary numerical result or analyses needed to quantify the outcome. The record should therefore be read as a description of study intent and selected observations, not as proof of comparative effectiveness or safety.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary question is about use per an approved indication, not a randomized contrast in treatment outcomes. That distinction matters: a descriptive measure of prescribing can address whether use matched a stated criterion, while a treatment-effect question asks how outcomes differ between strategies. The registry's single-group design is aligned with describing use, but it does not provide a randomized comparator for estimating a comparative treatment effect.
The endpoint is framed as a participant count, and its population is defined as enrolled participants who received at least one dose. Those definitions matter because interpreting a count depends on knowing who was assessed and how the criterion was applied. The registry record does not report the primary count or the size of that population. As a result, it cannot quantify how often use met the criterion or how precisely that estimate is known.
The record also demonstrates why endpoint definitions and endpoint results are not interchangeable. It supplies timing definitions for early and late onset of nosocomial pneumonia and ventilator-associated pneumonia, and lists multiple secondary outcomes. Definitions indicate what investigators intended to measure; they do not reveal the observed findings. With 0 analyses listed, the record contains no statistical estimate or test result to support inferential conclusions.
Finally, the safety entries are counts and selected term percentages without a randomized comparison or reported denominators for the term percentages. They can be read as descriptive registry entries, not as causal estimates. The value of the record is therefore in documenting the study's design, its utilization-focused objective and the outcome domains it planned to capture. Its statistical limits are equally important: numerical primary results, analysis details and comparative estimates are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report the primary endpoint count, the size of the intent-to-treat population, or an estimate with a measure of uncertainty. Although enrollment is listed as 216, the endpoint population is defined by receipt of at least one dose, and the number meeting that condition is not reported. The enrollment figure should not be substituted for an outcome denominator.
The single-group design, allocation listed as NA and absence of masking mean that no randomized control comparison is described. Consequently, outcomes cannot be interpreted as estimates of differences between treatment strategies. The record also does not report how participants were selected, whether enrollment was consecutive, or how the approved-indication criterion was operationalized.
Secondary outcomes are named but their numerical results are not reported in the registry record. Nor does the record describe outcome adjudication, follow-up completeness, missing-data handling, analysis populations beyond the stated intent-to-treat definition, or sensitivity analyses. The statistical analysis plan, treatment of multiplicity and any interim analyses are not reported in the registry record.
The safety counts are presented for infection categories, but the registry does not clarify event definitions, whether repeated events were counted separately, or how participants were assigned to the categories. Denominators and calculation methods for the serious adverse event term percentages are not reported. Death counts are not reported in the registry record. These omissions limit assessment of event frequency, completeness and causal attribution.
The registry lists conditions that include pneumonia, ventilator-associated pneumonia and urinary tract infections, while safety groupings also include complicated intra-abdominal infection. It does not explain the relationship between those lists or provide additional subgroup details. These limitations apply to interpretation of the registry record; they do not establish that information was unavailable to the investigators.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region — NCT00986102.
- Registry record last updated 2024-11-19; status last verified 2024-10.
- Results first posted 2013-02-07.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The PROUD Study is a completed prospective Phase 4 study of doripenem usage patterns in the Asia Pacific region. The registry lists enrollment of 216, a single-group model, no masking and allocation as NA. Doripenem is described as a 500mg vial by injection every 8 hours for 5 to 14 days.
The primary measure is the number of participants whose doripenem use was per the approved indication. Its population is the intent-to-treat population, defined as enrolled participants who received at least one dose. The primary count and population size are not reported in the registry record. Secondary outcomes cover clinical and microbiological response, resource utilization and readmission, but their results are also not reported.
Selected adverse event counts are listed for nosocomial pneumonia, ventilator-associated pneumonia, complicated urinary tract infection and complicated intra-abdominal infection. The record lists 10 outcome measures and 0 analyses. With no randomized comparator and no reported primary analysis, the available registry information supports description of study design and outcome definitions, but not a quantified treatment-effect conclusion.