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 Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia (NCT00707239), a randomized phase 2 study. The primary outcome is Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00707239 |
| Phase | Phase 2 |
| Condition | Pneumonia, Bacterial |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 108 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized participants with hospital-acquired pneumonia (HAP) were eligible for study treatment. The registry description states that at least 70% of enrolled participants would have ventilator-associated pneumonia (VAP). That is a stated study target, not a report of the proportion actually enrolled with VAP. The primary endpoint used the clinically evaluable (CE) population, described as participants who met specified efficacy-evaluability criteria.
Intervention
The trial compared two tigecycline regimens. The registry lists the safety groups as Tigecycline 75 mg and Tigecycline 100 mg. Treatment was intravenous, for a minimum of 7 and up to 14 consecutive days; the investigator determined duration based on the participant’s condition. Protocol-specified additional antibiotics could also be used to ensure appropriate coverage.
Comparator
The comparator was imipenem/cilastatin, listed in the safety groups as Imipenem/Cilastatin 1 Gram. The study was randomized, quadruple-masked, and parallel-group. The registry does not give further arm descriptions or explain the details of masking.
Primary question
The primary question concerned the percentage of participants in the CE population with a clinical response at the test-of-cure (TOC) visit. TOC was scheduled 10 to 21 days after the last day of therapy, with the primary timeframe described as Up to Day 24 to 35. The registry record does not report the primary endpoint results, so it does not show how clinical response compared across the regimens.
The study’s purpose was to compare safety and efficacy across the tigecycline regimens and the imipenem/cilastatin regimen in HAP. Clinical and microbiological efficacy were both planned for assessment. The secondary outcomes include clinical response in the c-mITT population, response by VAP status, and microbiological response at both pathogen and participant levels. These planned outcomes describe the breadth of the evaluation, but the registry record does not provide results for them.
3. Trial Design
NCT00707239 is a phase 2, randomized, quadruple-masked, parallel-group study sponsored by Pfizer. The registry lists enrollment of 108 and a status of terminated. The listed start was 2008-12 and the primary completion was 2011-06. The registry does not state why the study was terminated or provide details on how termination affected enrollment, follow-up, or analysis.
Three regimens were compared: Tigecycline 75 mg, Tigecycline 100 mg, and Imipenem/Cilastatin 1 Gram. The registry describes intravenous therapy for a minimum of 7 and up to 14 consecutive days, with duration decided by the investigator according to the participant’s condition. Additional protocol-specified antibiotics could be given to ensure appropriate coverage. The registry does not give the specific arm descriptions beyond the regimen names.
The planned population had HAP, with at least 70% of enrolled participants expected to have VAP. This is a design statement rather than a reported enrollment breakdown. The registry does not provide the actual number with VAP or non-VAP pneumonia, nor does it describe the demographic or clinical composition of the enrolled group.
The primary outcome was clinical response in the CE population at TOC. The registry defines TOC as occurring 10 to 21 days after the last day of therapy and gives a timeframe of Up to Day 24 to 35. Participants were to be followed for safety and efficacy, including clinical and microbiological assessments. The stated total participation duration was between 17 and 44 days, including a 30-day follow-up period after the last day of therapy for serious adverse events.
Randomization and masking can reduce some sources of bias, but the registry does not report the randomization method, allocation concealment procedures, or masking procedures. It also does not report the rationale for the enrollment target, interim analyses, or a detailed statistical analysis plan.
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.
Overall Study
| Stage | Tigecycline 75 mg | Tigecycline 100 mg | Imipenem/Cilastatin 1 Gram |
|---|---|---|---|
| STARTED | 37 | 36 | 35 |
| Treated | 36 | 35 | 34 |
| COMPLETED | 18 | 25 | 21 |
| NOT COMPLETED | 19 | 11 | 14 |
Reasons for not completing this period:
| Reason | Tigecycline 75 mg | Tigecycline 100 mg | Imipenem/Cilastatin 1 Gram |
|---|---|---|---|
| Adverse Event | 5 | 3 | 2 |
| Death | 3 | 1 | 3 |
| Physician Decision | 1 | 1 | 2 |
| Protocol Violation | 0 | 0 | 1 |
| Lack of Efficacy | 1 | 2 | 0 |
| Randomized, but not treated | 1 | 1 | 1 |
| Other | 8 | 3 | 5 |
Analysis population for the primary outcome, as defined in the registry: CE population included those participants who met specified evaluability criteria for efficacy.
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 | Tigecycline 75 mg | Tigecycline 100 mg | Imipenem/Cilastatin 1 Gram | Total |
|---|---|---|---|---|---|
| Participants analysed | 36 | 35 | 34 | 105 | |
| Age Continuous | years | 60.31 (SD 14.82) | 61.46 (SD 16.05) | 64.85 (SD 15.33) | 62.16 (SD 15.37) |
| Sex: Female, Male: Female | Participants | 13 | 16 | 5 | 34 |
| Sex: Female, Male: Male | Participants | 23 | 19 | 29 | 71 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit, measured over Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT]).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the percentage of participants in the clinically evaluable (CE) population with a clinical response at the test-of-cure (TOC) visit. The CE population included participants who met specified efficacy-evaluability criteria. The registry does not describe those criteria in detail, so the exact rules determining inclusion in this analysis are not available in the record.
The endpoint classified clinical outcomes as cure, failure, or indeterminate. Cure required improvement in all initial signs and symptoms of pneumonia, an improved or stable chest x-ray, no other antibiotics for pneumonia, and no worsening or new signs and symptoms. Failure included persistence or worsening of signs and symptoms, absence of clinical improvement, clinically important worsening after initial improvement, use of other antimicrobials for pneumonia, chest x-ray progression, or death greater than study day 2 due to pneumonia. Indeterminate status applied when the outcome could not be determined for reasons unrelated to study drug or infection, including loss to follow-up, or for specified deaths before the TOC visit.
In general, a clinical-response endpoint summarizes whether participants meet predefined clinical criteria at a chosen follow-up point. It gives a clinically interpretable outcome, while the explicit cure, failure, and indeterminate definitions help make classification more consistent. The endpoint’s timing matters because clinical status can change during treatment and after treatment ends. The registry record does not report the observed response percentages, so the endpoint’s results cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome but does not report its result. It gives no clinical-response percentage for the CE population at TOC, no comparison between treatment groups, and no uncertainty estimate for the primary outcome. The record therefore does not establish how the regimens compared on the primary endpoint. The outcome is classified as unsuitable for reduction to a single comparison because it has several categories or time points; the endpoint itself includes cure, failure, and indeterminate categories.
The enrollment listed is 108, but this is not the number analyzed for the primary endpoint. The endpoint population was CE, defined by meeting specified efficacy-evaluability criteria. Group-specific primary-analysis denominators are not reported in the registry record. The secondary outcomes also identify other analysis populations, including c-mITT, VAP and non-VAP participants, and microbiological populations. Their results and denominators are not reported.
The safety entries give numbers of participants at risk and affected in each listed regimen group. For serious adverse events, the registry lists 36 at risk and 12 affected in Tigecycline 75 mg, 35 at risk and 9 affected in Tigecycline 100 mg, and 34 at risk and 10 affected in Imipenem/Cilastatin 1 Gram. These are descriptive counts; the record does not provide a comparative safety estimate or an uncertainty interval. Counts for other adverse events are also listed, but they do not substitute for the missing efficacy results.
The registry separately lists serious adverse event terms with percentages, including Septic shock at 11.1%, Cardiac arrest at 5.9%, Pneumothorax at 5.9%, Pneumonia at 5.7%, Vascular disorders at 5.6%, and Ventricular fibrillation at 2.9%. The record does not identify these percentages by treatment group or provide their denominators in the listed information. They should not be read as treatment-specific comparisons.
No p-value, confidence interval, adjusted effect estimate, or unadjusted effect estimate for the primary endpoint is reported in the registry record. In general, a confidence interval describes the range of estimates compatible with the data under a statistical procedure; its width reflects precision as well as sample information. Without a reported effect estimate and interval, neither the magnitude nor precision of the primary comparison can be evaluated.
The status is terminated, but the reason and consequences are not reported. Termination alone does not establish that results are biased or that the study stopped for a particular reason. It does mean that interpretation should stay tied to the information actually recorded: planned design details, enrollment, and the listed safety counts, rather than unreported comparative efficacy findings.
9. Statistical Methods Explained
The registry identifies a randomized, quadruple-masked, parallel-group phase 2 study. These design features describe how participants were intended to receive treatment and how knowledge of assignment was intended to be limited. In general, randomization helps balance measured and unmeasured characteristics across groups on average, while masking can reduce bias in care, outcome assessment, or reporting. The registry does not describe the randomization procedure, allocation concealment, or which parties were masked, so those implementation details cannot be evaluated.
The primary outcome is a percentage: the share of participants meeting the clinical-response definition in the CE population at TOC. A percentage is a proportion expressed on a percentage scale. In general, its interpretation depends on both the count meeting the definition and the denominator eligible for analysis. The registry lists the CE population definition only broadly, and does not give the primary outcome counts or denominators by treatment group. No primary response estimate can therefore be interpreted from the record.
The endpoint has three possible classifications: cure, failure, and indeterminate. That structure is important for statistical interpretation. In general, a multi-category endpoint contains more information than a single binary outcome, but a simple comparison requires an explicit choice about how categories are handled. For example, an analysis might compare each category separately or define a combined outcome; the registry record does not report such a decision or a result. The posted classification rules describe what outcomes mean, but they do not by themselves specify the statistical model or comparison.
The endpoint is assessed at TOC, scheduled 10 to 21 days after the last day of therapy. The primary timeframe is also stated as Up to Day 24 to 35. In general, a fixed assessment window makes the timing of the endpoint explicit, while variation in when participants are assessed can affect the information available. The registry does not report actual assessment timing by participant, the handling of assessments outside the stated window, or the frequency of missing TOC assessments.
The record lists 19 outcome measures and 16 analyses. It also describes secondary clinical and microbiological outcomes, including outcomes in c-mITT participants and analyses by VAP status. In general, examining multiple outcomes or populations raises multiplicity concerns: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Whether and how to control that issue depends on the prespecified testing strategy. The registry record does not report a multiplicity adjustment, a hierarchy among endpoints, or which analyses were confirmatory.
The population definitions require attention. The primary endpoint uses the CE population, which is restricted to participants meeting specified efficacy-evaluability criteria. The secondary outcome list includes c-MITT and pathogen-level and participant-level populations. In general, restricting an analysis after randomization can affect comparability if exclusions are associated with treatment or outcome. A modified intention-to-treat analysis can also differ from a full randomized-population analysis, depending on its rules. The registry does not provide enough detail to determine how participants were included or excluded, or whether sensitivity analyses assessed the impact of population choice.
Missing data are especially relevant when response can be indeterminate. The endpoint definition includes inability to determine the outcome for reasons such as loss to follow-up, as well as specified deaths. In general, missing-data handling can change an estimated response proportion depending on whether missing outcomes are excluded, counted as failures, imputed, or handled through another method. The registry record does not report the method used for indeterminate outcomes or other missing observations. It also does not report counts of missing or unevaluable participants by group.
The record reports serious adverse event counts for each regimen group and lists other adverse event counts. These are descriptive safety summaries. In general, a treatment comparison should account for the number of participants at risk and the event definition; repeated events in one participant may also differ from counts of participants with at least one event. The listed information gives affected-participant counts, but does not describe event-level analysis, exposure-adjusted rates, statistical comparisons, or uncertainty intervals. Death counts are not reported in the registry record.
The sample-size assumptions described for planning illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These are characteristics of planning illustrations, not evidence of the trial’s own design justification. The registry does not report the protocol’s sample-size justification or explain whether those assumptions were used in planning the trial. Any such illustration should be understood as a planning exercise, not observed power. In general, power is a design property under stated assumptions; it does not measure the probability that a completed study’s result is true.
The record does not report interim analyses or a detailed statistical analysis plan. It also does not report a primary treatment-effect estimate, confidence interval, or p-value. These omissions prevent assessment of the exact inferential procedure, prespecified analysis choices, and precision of the primary comparison. General statistical concepts can clarify what such information would mean, but they cannot replace the missing trial-specific results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 19 outcome measures and 16 analyses, including the primary clinical-response outcome and secondary clinical and microbiological outcomes. A broad outcome set can answer different questions, but interpretation depends on which outcomes were prespecified as primary, how comparisons were organized, and whether adjustment for multiple testing was planned. The record does not report a testing hierarchy, multiplicity adjustment, or a detailed statistical analysis plan. It is therefore not possible to determine which comparisons were treated as confirmatory or how the risk of false-positive findings was managed.
The primary analysis population was CE, described as participants who met specified efficacy-evaluability criteria. Secondary outcomes include c-MITT and VAP/non-VAP populations, as well as microbiological outcomes at pathogen and participant levels. These populations need not contain the same participants. The registry does not provide group-specific denominators or detailed eligibility rules for these analyses, so the impact of population selection cannot be assessed.
The primary endpoint includes an indeterminate category, and the definition includes loss to follow-up and specified deaths. The registry record does not report how indeterminate outcomes or other missing data were handled statistically, how many participants had missing assessments, or whether sensitivity analyses were performed. As a result, the robustness of any primary estimate to missingness cannot be evaluated.
The registry does not report interim analyses, the reason for termination, or the protocol’s sample-size justification. Those omissions do not establish that a particular procedure was or was not used; they limit what can be concluded about design and analysis choices from the registry record.
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 |
|---|---|---|---|
| Tigecycline 75 mg | 12 | 36 | 33.3% |
| Tigecycline 100 mg | 9 | 35 | 25.7% |
| Imipenem/Cilastatin 1 Gram | 10 | 34 | 29.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 3% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Tigecycline 75 mg | 28 of 36 |
| Tigecycline 100 mg | 25 of 35 |
| Imipenem/Cilastatin 1 Gram | 26 of 34 |
Most frequent serious adverse event terms
| Event term | Organ system | Tigecycline 75 mg | Tigecycline 100 mg | Imipenem/Cilastatin 1 Gram |
|---|---|---|---|---|
| Septic shock | Infections and infestations | 4 of 36 | 1 of 35 | 2 of 34 |
| Pneumonia | Infections and infestations | 1 of 36 | 2 of 35 | 0 of 34 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 36 | 0 of 35 | 2 of 34 |
| Vascular disorders | Respiratory, thoracic and mediastinal disorders | 2 of 36 | 1 of 35 | 0 of 34 |
| Cardiac arrest | Cardiac disorders | 0 of 36 | 0 of 35 | 2 of 34 |
| Sepsis | Infections and infestations | 1 of 36 | 1 of 35 | 0 of 34 |
| Shock | Respiratory, thoracic and mediastinal disorders | 1 of 36 | 1 of 35 | 0 of 34 |
| Atrial flutter | Cardiac disorders | 1 of 36 | 0 of 35 | 0 of 34 |
| Sinoatrial block | Cardiac disorders | 0 of 36 | 1 of 35 | 0 of 34 |
| Tachyarrhythmia | Cardiac disorders | 0 of 36 | 1 of 35 | 0 of 34 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tigecycline 75 mg | Tigecycline 100 mg | Imipenem/Cilastatin 1 Gram |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 6 of 36 | 6 of 35 | 5 of 34 |
| Hypokalaemia | Metabolism and nutrition disorders | 4 of 36 | 3 of 35 | 4 of 34 |
| Anaemia | Blood and lymphatic system disorders | 3 of 36 | 4 of 35 | 3 of 34 |
| Vomiting | Gastrointestinal disorders | 4 of 36 | 2 of 35 | 4 of 34 |
| Constipation | Gastrointestinal disorders | 1 of 36 | 2 of 35 | 6 of 34 |
| Pyrexia | General disorders | 3 of 36 | 4 of 35 | 2 of 34 |
| Lipase increased | Investigations | 3 of 36 | 3 of 35 | 1 of 34 |
| Nausea | Gastrointestinal disorders | 2 of 36 | 4 of 35 | 1 of 34 |
| Atrial fibrillation | Cardiac disorders | 0 of 36 | 0 of 35 | 6 of 34 |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | 1 of 36 | 3 of 35 | 2 of 34 |
Serious events with the highest arm-level rate: septic shock (11.1%), cardiac arrest (5.9%), pneumothorax (5.9%), pneumonia (5.7%), vascular disorders (5.6%).
The serious adverse event counts are reported by regimen group. Tigecycline 75 mg lists 36 participants at risk and 12 affected; Tigecycline 100 mg lists 35 at risk and 9 affected; Imipenem/Cilastatin 1 Gram lists 34 at risk and 10 affected. The record also lists other adverse events: 36 at risk and 28 affected for Tigecycline 75 mg, 35 at risk and 25 affected for Tigecycline 100 mg, and 34 at risk and 26 affected for Imipenem/Cilastatin 1 Gram. These are participant counts, not comparative risk estimates or adjusted treatment effects.
The registry lists serious adverse event terms and percentages: Septic shock, 11.1%; Cardiac arrest, 5.9%; Pneumothorax, 5.9%; Pneumonia, 5.7%; Vascular disorders, 5.6%; and Ventricular fibrillation, 2.9%. The listed terms are not assigned to individual treatment groups in the registry information, and their denominators are not specified there. They cannot be used to infer a regimen-specific rate or compare groups.
In general, adverse-event summaries depend on definitions, observation time, participant exposure, and whether the count represents affected participants or event occurrences. The registry lists no death counts. These safety data should be read as descriptive registry entries, not as evidence establishing a causal difference between regimens.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel-group phase 2 study was registered to compare two tigecycline regimens with imipenem/cilastatin for HAP. It describes the primary clinical-response endpoint, its TOC timing, and the classification rules for cure, failure, and indeterminate outcomes. It also lists safety counts by regimen group and several serious adverse event terms with percentages.
It does not report the primary clinical-response results. There is no group-specific response percentage, treatment-effect estimate, confidence interval, or p-value in the registry record. The record therefore cannot show the size, direction, or precision of a primary efficacy comparison. The same limitation applies to the listed secondary outcomes: their names are present, but their results are not reported in the information available.
The safety counts can be described as the numbers of participants at risk and affected within each listed group. They do not, by themselves, establish whether one regimen has a different safety profile from another. The serious adverse event terms are not separated by treatment group in the listed information, and the registry does not report death counts. No causal conclusion about safety follows from these entries alone.
The status of terminated is relevant context, but the registry does not state the reason for termination or its consequences. Enrollment is listed as 108, but the primary endpoint’s CE population may differ from total enrollment, and its group-specific analysis denominators are not reported. The planned expectation that at least 70% of enrolled participants would have VAP is not a report of the observed participant mix.
In general, a trial result needs an effect estimate, a clear analysis population, and an indication of uncertainty to support a precise statistical interpretation. The available record describes the study question and some design and safety information, but lacks the primary outcome findings needed to evaluate the clinical-response comparison. It does not establish that a regimen is effective, ineffective, safer, or less safe.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record separates a detailed endpoint definition from the absence of the endpoint’s results. The primary outcome is not simply an unspecified judgment: the record defines cure, failure, and indeterminate status and identifies the CE analysis population and TOC timing. Yet those definitions cannot answer the comparative question without outcome counts, denominators, and an effect estimate.
The endpoint has multiple categories, while the listed study includes numerous outcomes and analyses. This makes the prespecified analysis strategy important. Choices about how to handle indeterminate outcomes, which populations to analyze, and how to account for multiple comparisons can shape interpretation. The registry record does not report these details, so the existence of several planned analyses should be distinguished from evidence that a particular analysis was used.
The record also illustrates why design targets must be kept separate from observed sample composition. At least 70% of enrolled participants were expected to have VAP, but the actual VAP proportion is not reported. Similarly, enrollment of 108 does not identify the number evaluable for the CE primary endpoint. A total enrollment figure is not a substitute for outcome-specific denominators.
Finally, the safety entries are useful as descriptive counts, but do not provide treatment-specific event estimates for the listed serious terms or a formal comparison. The terminated status and missing efficacy results further constrain interpretation, without revealing the reason for termination. Together, these features show why a registry record can document a study’s intended question and some observed safety information while remaining insufficient for judging its primary comparative result.
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 most consequential limitation is that the registry record does not report the primary clinical-response results. It gives no treatment-group response estimates, analysis denominators, effect estimate, confidence interval, or p-value. The primary comparison’s magnitude and precision cannot be evaluated.
The registry describes the CE population only as participants meeting specified efficacy-evaluability criteria. It does not give the detailed criteria, participant flow, exclusions, or group-specific numbers in the primary analysis. The record also does not report actual enrollment by VAP status, despite the stated expectation that at least 70% of participants would have VAP. This prevents assessment of how closely the enrolled population matched that target or how applicable the results might be to VAP and non-VAP groups.
The study status is terminated, but the reason, timing, and consequences of termination are not reported. The registry does not explain whether termination affected enrollment, follow-up, outcome collection, or analysis. It would be speculative to infer a reason from status alone.
The safety information has additional limits. Serious adverse event counts are listed by group, while the serious adverse event terms and percentages are not assigned to groups in the listed information. Denominators for those term percentages are not reported. Death counts, exposure-adjusted summaries, uncertainty estimates, and comparative safety analyses are also not reported.
Finally, the record does not provide the detailed statistical analysis plan, sample-size justification, multiplicity strategy, missing-data methods, or interim-analysis information. These omissions limit assessment of prespecification and analysis robustness. They do not show that any particular method was used or omitted in the conduct of the trial; they define what cannot be established from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia — NCT00707239.
- Registry record last updated 2012-07-10; status last verified 2012-06.
- Results first posted 2012-07-10.
- 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
NCT00707239 is a terminated phase 2 randomized, quadruple-masked, parallel-group study sponsored by Pfizer. Enrollment is listed as 108. The study compared Tigecycline 75 mg and Tigecycline 100 mg with Imipenem/Cilastatin 1 Gram for hospital-acquired pneumonia. The registry states that at least 70% of enrolled participants would have VAP, but does not report the observed proportion.
The primary outcome was clinical response in the CE population at TOC, with cure, failure, and indeterminate classifications. The registry record does not report the primary outcome results or treatment-group comparisons. It lists serious adverse event counts by regimen group and several serious adverse event terms with percentages, but the terms are not assigned to treatment groups in the listed information. The reason for termination, detailed analysis plan, and missing-data methods are not reported in the registry record.