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 A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia (NCT01808092), a randomized phase 3 study. The primary outcome is The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01808092 |
| Phase | Phase 3 |
| Condition | Nosocomial Pneumonia (NP), Ventilator-associated Pneumonia (VAP) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 969 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Hospitalized adults with nosocomial pneumonia, including ventilator-associated pneumonia, were eligible for the trial. The primary endpoint population was the clinical modified intent-to-treat set: patients who met minimum disease criteria, received any study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
Intervention
Ceftazidime-avibactam, identified in the registry record as CAZ-AVI, was given by intravenous treatment. The trial was designed to compare its efficacy, safety, and tolerability with meropenem.
Comparator
Meropenem was the active comparator and was also given by intravenous treatment. Both treatments were studied within a randomized, parallel-group trial.
Primary question
The co-primary endpoint asked how many patients in the clinical modified intent-to-treat population met the clinical-cure criteria at the test-of-cure visit, scheduled for Day 21 to 25. The registry record does not report the group counts or a between-group effect estimate for this outcome, so the comparative result cannot be assessed from that record.
The cure definition combined the patient's status at the end of treatment with their subsequent clinical course. A patient had to be free of clinical failure at the end of treatment, alive at test of cure, and have all pneumonia signs and symptoms resolved or improved enough that no antibacterial therapy for nosocomial pneumonia was taken between the end-of-treatment and test-of-cure visits, inclusive. This definition makes the endpoint a clinical status assessment at a specified follow-up visit rather than a measure of a single symptom or a laboratory finding.
The question is therefore not simply whether patients received either antibiotic or whether a pathogen was present. It concerns the count meeting a composite clinical definition in a population selected by disease and baseline-pathogen criteria. The record describes a comparison intended to evaluate the treatments, but it does not report enough primary-outcome results to establish the direction, magnitude, or precision of any difference.
3. Trial Design
The registry record describes a Phase III, randomized, multicentre, double-blind, double-dummy, parallel-group comparative study. Its stated purpose was to evaluate the efficacy, safety, and tolerability of ceftazidime-avibactam versus meropenem for nosocomial pneumonia, including ventilator-associated pneumonia, in hospitalized adults. The masking field is recorded as quadruple. The record does not explain which people or roles were included in that masking designation, so further details of the masking arrangement are not reported in the registry record.
The study was listed as completed and had an enrollment of 969. The registry record gives a start of 2013-04 and a primary completion of 2016-01. Those dates describe the study timeline in the record; they do not supply participant-level follow-up information or the timing of each person's assessment. Both interventions are described as intravenous treatment. Meropenem is identified as the active comparator.
Random allocation and a parallel-group model indicate that participants were assigned to one of the treatment groups and followed in those groups, rather than crossing between treatments as part of the listed design. Randomization is intended to reduce systematic differences between groups at the point of assignment. It does not guarantee identical groups in every respect, and the record does not provide the allocation procedure, allocation ratio, or details of any stratification.
The primary outcome listing concerns clinical cure at the test-of-cure visit, with a timeframe of Day 21 to 25. It identifies co-primary analyses and defines the clinical modified intent-to-treat population. There are also 49 outcome measures and 2 analyses listed in the record, but the detailed analysis procedures and results for the primary comparison are not reported in the registry record. The enrollment total should not be treated as the denominator for every outcome: analysis populations and outcome-specific denominators can differ, and the primary endpoint counts are not reported.
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: The first patient was enrolled on 13 April 2013 and the last patient last vist was on 07 January 2016. Overall, 969 patients were enrolled in this study, 90 of them screen failures.
Overall Study
| Stage | CAZ-AVI | Meropenem |
|---|---|---|
| STARTED | 409 | 408 |
| COMPLETED | 355 | 363 |
| NOT COMPLETED | 54 | 45 |
Reasons for not completing this period:
| Reason | CAZ-AVI | Meropenem |
|---|---|---|
| Death | 39 | 29 |
| Lost to Follow-up | 3 | 7 |
| Withdrawal by Subject | 9 | 4 |
| Other Eligibility criteria | 3 | 5 |
Analysis population for the primary outcome, as defined in the registry: The clinical modified intent-to-treat (cMITT) included all patients who met the minimum disease criteria and received any amount of study treatment, and had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen.
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.
Population: Baseline characteristics analysis is based on safety analysis set: randomized patients who received any amount of study therapy. 9 patients were randomized but not treated.
| Characteristic | Unit | CAZ-AVI | Meropenem | Total |
|---|---|---|---|---|
| Participants analysed | 405 | 403 | 808 | |
| Age, Continuous | Years | 61.8 (SD 16.76) | 61.7 (SD 17.57) | 61.7 (SD 17.16) |
| Age, Customized: 18-45 | Participants | 74 | 74 | 148 |
| Age, Customized: 46-64 | Participants | 124 | 122 | 246 |
| Age, Customized: 65-74 | Participants | 97 | 95 | 192 |
| Age, Customized: 75-90 | Participants | 110 | 112 | 222 |
| Sex: Female, Male: Female | Participants | 101 | 105 | 206 |
| Sex: Female, Male: Male | Participants | 304 | 298 | 602 |
| Race/Ethnicity, Customized: Asian | Participants | 226 | 217 | 443 |
| Race/Ethnicity, Customized: Black/African American | Participants | 3 | 2 | 5 |
| Race/Ethnicity, Customized: Native Hawaiian/Pacific Islander | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Other | Participants | 5 | 7 | 12 |
| Race/Ethnicity, Customized: White | Participants | 171 | 177 | 348 |
6. Primary Endpoint
The registry lists the primary outcome as The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses), measured over At the test-of-cure (TOC) visit (Day 21 to 25).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts patients classified as having clinical cure at the test-of-cure visit, scheduled for Day 21 to 25. The registry definition requires that a patient was not a clinical failure at the end of treatment, was alive at test of cure, and had all signs and symptoms of pneumonia resolved or improved to an extent that no antibacterial therapy for nosocomial pneumonia was taken between the end of treatment and test of cure, inclusive. It is therefore a defined clinical outcome that incorporates both clinical status and the need for additional antibacterial treatment during the specified interval.
The outcome is listed as a number of participants, so the underlying data type is a count of people meeting the cure criteria. In a treatment comparison, that count is ordinarily interpreted alongside the number assessed in each group. The number alone would not describe the proportion meeting the endpoint unless its denominator were also known. The registry record does not report the primary endpoint counts or group denominators for this analysis.
Clinical cure is used to assess the patient's overall pneumonia-related clinical status rather than a single sign, symptom, or microbiological result. The specified population further restricts the endpoint analysis to patients meeting the disease and treatment criteria and the baseline-pathogen condition in the definition. The record does not give an estimate of how many patients met the endpoint, how the groups compared, or how precise that comparison was. Consequently, the endpoint definition can be described, but its observed comparative result cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison and identifies clinical cure at test of cure as a co-primary outcome. However, it does not report the outcome counts by treatment group, the denominators for the primary analysis, or a comparative effect estimate. It also does not report a confidence interval or p-value for this endpoint. Without those results, the direction and size of the observed treatment difference, and the precision of that difference, are not reported in the registry record.
The word “number” in the endpoint title refers to patients meeting the cure definition. It should not be read as a group rate or treatment effect on its own. To compare groups, readers need the number meeting the endpoint together with the number assessed in each group, and an appropriate measure of the between-group difference. Those primary-outcome figures are not reported in the registry record. The total enrollment of 969 does not replace those missing denominators, because the primary endpoint uses a specifically defined analysis population.
The record identifies two analyses and calls the primary outcome co-primary. That establishes that the primary evaluation was not described as a single standalone analysis, but it does not reveal the results or the rules for interpreting multiple co-primary tests. The statistical plan, including the testing hierarchy or any adjustment for multiplicity, is not reported in the registry record. Therefore, there is no basis in the record to decide whether a particular threshold was met or how any co-primary findings should be combined.
The safety information is separate from the missing primary efficacy comparison. The adverse-event entries report serious adverse events and other adverse events for the two groups, and list several serious-event terms with percentages. Those entries describe recorded safety events in the listed groups; they do not supply a complete account of all event types, event timing, severity gradations, or causal attribution. Death counts are not reported. A numerical comparison of event counts alone would not establish that an event was caused by a treatment, nor would it resolve the clinical-cure question.
Planning illustrations are also distinct from trial results. The described planning approach uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. Such calculations are planning scenarios, not observed power, and they do not fill in unreported endpoint results. No conclusion about the primary treatment comparison can be drawn from a planning illustration without the observed outcome data.
9. Statistical Methods Explained
What kind of endpoint is this? The registry lists the primary outcome as a number of participants meeting a clinical-cure definition. In statistical terms, each eligible participant can be classified according to whether the defined outcome occurred by the specified assessment. The group result is a count, while a comparison between groups generally needs the count and the corresponding number of participants assessed. A count without its denominator cannot show how frequently the outcome occurred in that group. The registry record does not report the primary counts or denominators.
What does randomization contribute? Random assignment is intended to make treatment groups comparable, on average, with respect to both measured and unmeasured baseline characteristics. This supports interpretation of a between-group comparison, provided the assignment is implemented as planned and outcome data are analyzed appropriately. Randomization does not remove uncertainty, guarantee balance in every characteristic, or compensate for incomplete outcome reporting. The record says the study was randomized, but the allocation sequence, concealment procedures, and allocation ratio are not reported in the registry record.
How should masking be understood? The design is described as double-blind and double-dummy, and the registry masking field records quadruple masking. Masking can limit the influence of expectations on care, outcome assessment, or reporting. Double-dummy designs are generally used when treatment regimens differ in a way that makes matching treatment procedures relevant; however, the particular rationale and implementation details are not reported in the registry record. The record does not identify which roles were masked or explain whether masking was maintained throughout follow-up.
What does a confidence interval communicate? In general, a confidence interval describes the range of values for an effect estimate that are compatible with the observed data under the specified statistical method. Its width reflects precision: a narrower interval indicates more precise estimation than a wider interval. The interval also helps readers judge whether the data are compatible with effects of different sizes and directions. No primary-outcome effect estimate or confidence interval is reported in the registry record, so precision cannot be evaluated for the clinical-cure comparison.
What does a p-value communicate? In general, a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions were true. It is not the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. A p-value needs to be read with the effect estimate, its uncertainty, the endpoint definition, and the analysis plan. The primary-outcome p-value and the testing details are not reported in the registry record.
Why does multiplicity matter? The primary outcome is labelled co-primary, and the record lists 2 analyses. When more than one primary hypothesis is assessed, the chance of at least one false-positive conclusion can depend on how the tests are planned and interpreted. Common approaches can allocate a significance level across tests or use a specified decision rule, but the record does not state which approach was used. No multiplicity adjustment or co-primary success rule should be assumed from the fact that the endpoint is labelled co-primary.
What do planning illustrations mean? The described sample-size assumptions use a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. These are planning assumptions, not evidence of an observed treatment effect and not a report of observed power. A planning estimate can indicate the scale of a hypothetical study under stated assumptions, but its interpretation depends on those assumptions. Sample-size illustrations are not a substitute for the primary group counts, effect estimate, or confidence interval, none of which are reported for the primary endpoint in the registry record.
Why do analysis populations matter? The primary population is the clinical modified intent-to-treat set. It includes patients who met minimum disease criteria and received any amount of study treatment, with either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen. This definition is more specific than simply including everyone enrolled. Applying population criteria can change which participants contribute to an outcome analysis, so the analyzed denominator is important. The record lists other microbiological and clinical analysis sets among secondary outcomes, but their full definitions and the actual primary denominators are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is explicitly described as a co-primary analysis, and the registry record lists 2 analyses. Multiple primary analyses require a prespecified interpretation rule if the overall conclusion is to account for the chance of false-positive findings across tests. The record does not report whether both analyses had to meet a criterion, whether one result could support a conclusion on its own, whether a hierarchy was used, or whether the significance level was adjusted. The results of the co-primary analyses are not reported in the registry record.
Missing outcome data can affect an analysis when participants do not attend an assessment or cannot be classified under the endpoint definition. Appropriate interpretation depends on how much data are missing, why they are missing, and how the analysis handles them. The registry record does not report the amount or reasons for missing primary endpoint data, any imputation approach, or sensitivity analyses addressing missingness. No particular missing-data procedure should therefore be inferred.
The primary analysis population is defined as the clinical modified intent-to-treat set. It includes patients who met minimum disease criteria and received any amount of study treatment, and who had either no baseline pathogens or at least one study-qualifying Gram-negative baseline pathogen. This population definition is relevant to the scope of the endpoint result. The record also names clinical and microbiological analysis sets for secondary outcomes, but their full operational definitions are not reported in the registry record.
The total enrollment of 969 is not a substitute for the number contributing to the primary analysis. The record does not give the primary outcome denominators or participant flow for that endpoint. It also does not provide enough information to assess whether exclusions, missing assessments, or differences among analysis populations could have changed the comparison.
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 |
|---|---|---|---|
| CAZ-AVI | 75 | 405 | 18.5% |
| Meropenem | 54 | 403 | 13.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| CAZ-AVI | 198 of 405 |
| Meropenem | 195 of 403 |
Most frequent serious adverse event terms
| Event term | Organ system | CAZ-AVI | Meropenem |
|---|---|---|---|
| Pneumonia | Infections and infestations | 7 of 405 | 6 of 403 |
| Sepsis | Infections and infestations | 5 of 405 | 4 of 403 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 5 of 405 | 4 of 403 |
| Cardiac failure | Cardiac disorders | 4 of 405 | 3 of 403 |
| Septic shock | Infections and infestations | 3 of 405 | 3 of 403 |
| Cardiac arrest | Cardiac disorders | 2 of 405 | 3 of 403 |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | 4 of 405 | 1 of 403 |
| Death | General disorders | 3 of 405 | 1 of 403 |
| Multi-organ failure | General disorders | 3 of 405 | 1 of 403 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 405 | 3 of 403 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CAZ-AVI | Meropenem |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 60 of 405 | 62 of 403 |
| Hypokalaemia | Metabolism and nutrition disorders | 43 of 405 | 33 of 403 |
| Constipation | Gastrointestinal disorders | 25 of 405 | 31 of 403 |
| Vomiting | Gastrointestinal disorders | 23 of 405 | 22 of 403 |
| Anaemia | Blood and lymphatic system disorders | 24 of 405 | 18 of 403 |
| Alanine aminotransferase increased | Investigations | 16 of 405 | 19 of 403 |
| Aspartate aminotransferase increased | Investigations | 16 of 405 | 17 of 403 |
| Oedema peripheral | General disorders | 17 of 405 | 15 of 403 |
| Hypertension | Vascular disorders | 14 of 405 | 15 of 403 |
| Urinary tract infection | Infections and infestations | 11 of 405 | 14 of 403 |
Serious events with the highest arm-level rate: pneumonia (1.7%), sepsis (1.2%), respiratory failure (1.2%), cardiac failure (1.0%), pneumonia aspiration (1.0%).
The safety entries list 405 participants at risk in the CAZ-AVI group and 403 in the meropenem group for both serious and other adverse events. Serious adverse events are recorded for 75 participants in the CAZ-AVI group and 54 in the meropenem group. Other adverse events are recorded for 198 participants in the CAZ-AVI group and 195 in the meropenem group. These are event counts among the listed groups; they are not the primary clinical-cure outcome.
The registry record lists the following serious adverse-event terms and percentages: Pneumonia, 1.7%; Sepsis, 1.2%; Respiratory failure, 1.2%; Cardiac failure, 1.0%; Pneumonia aspiration, 1.0%; and Cardiac arrest, 0.7%. The record does not provide the denominators or additional detail for these term-specific percentages in the listed information, so they should be read as reported rather than converted into counts. The deaths field is not reported in the registry record.
These figures are descriptive. They do not by themselves show whether an event was caused by a study treatment, when it occurred, whether an individual had more than one event, or how event risks compare after accounting for uncertainty. The listed serious-event terms are not a complete narrative of the safety assessment, and the record does not report all details needed to characterize severity, duration, or clinical course.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group study compared intravenous ceftazidime-avibactam with intravenous meropenem in hospitalized adults with nosocomial pneumonia, including ventilator-associated pneumonia. It also defines a co-primary clinical-cure endpoint and specifies the population and test-of-cure timeframe used for that endpoint. These details explain what the planned comparison concerned and how cure was defined.
The record does not report the primary endpoint counts, denominators, between-group effect estimate, confidence interval, or p-value. As a result, the posted information does not establish which group had more patients meeting the clinical-cure definition, the size of any observed difference, or the precision of a comparison. It is not possible to conclude from the record whether a statistical decision rule was met. The endpoint label and trial design alone are not results.
The safety entries provide counts for serious and other adverse events in the listed groups and percentages for selected serious-event terms. Those data are descriptive and do not establish treatment causality or provide a full comparative safety analysis. Death counts are not reported in the registry record. Safety counts also cannot be used as a substitute for the clinical-cure outcome.
More broadly, a study result is interpreted in relation to its outcome definition, analysis population, missing data, statistical plan, and uncertainty. Several of those details are absent from the record, including the co-primary decision rule, missing-data handling, and primary comparison estimates. The registry record therefore supports a description of the study question and design, but not a conclusion about the comparative efficacy or overall benefit of either treatment. No medical decision should be inferred from the incomplete primary results.
13. Why This Trial Matters Statistically
This trial illustrates why an endpoint title and a completed randomized design are not enough to interpret a treatment comparison. The endpoint is carefully defined: it counts patients who are alive at the test-of-cure visit, were not clinical failures at the end of treatment, and had pneumonia signs and symptoms resolved or improved sufficiently that no further antibacterial therapy was taken in the specified interval. That definition gives the outcome clinical meaning, but it does not tell readers how often it occurred in either group.
The analysis population also matters. The clinical modified intent-to-treat set is defined by disease criteria, receipt of any study treatment, and baseline-pathogen status. Its scope differs from an all-enrolled population. Reporting the outcome denominators alongside counts would allow readers to understand precisely which patients contributed to the comparison. Those primary-outcome results are not reported in the registry record.
The co-primary designation highlights another important statistical issue: multiple primary tests need an interpretation plan. Without the decision rule, readers cannot tell how evidence from the co-primary analyses was intended to support an overall conclusion. Likewise, without an effect estimate and its uncertainty, statistical significance and practical importance cannot be evaluated. The record identifies 2 analyses but does not report their primary results or the multiplicity strategy.
Finally, planning illustrations and observed evidence answer different questions. Calculations under stated assumptions describe hypothetical planning scenarios; they do not recover missing trial outcomes or establish observed power. The distinction is useful whenever a registry contains design information and safety counts but lacks the primary comparative estimates. In this case, the design can be described, but the central efficacy comparison cannot be judged from the reported primary results.
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 central limitation for interpreting the clinical-cure endpoint is that its group counts and denominators are not reported in the registry record. No comparative effect estimate, confidence interval, or p-value is reported for the primary outcome. Without these values, readers cannot assess the direction, magnitude, or precision of the treatment comparison.
The endpoint is described as co-primary, and 2 analyses are listed, but the record does not explain the success criterion across those analyses or whether any multiplicity procedure was applied. It also does not report the full statistical analysis plan, missing-data methods, sensitivity analyses, or participant flow into the primary analysis. These omissions limit assessment of how robust the intended comparison was to analytical choices and unavailable outcome data.
The clinical modified intent-to-treat population is defined, but the number of participants meeting its criteria and contributing to the primary outcome is not reported. The total enrollment of 969 cannot be assumed to be the denominator for the primary analysis. Full definitions for the other clinical and microbiological analysis populations are also not reported in the registry record.
Safety information is limited to the reported event counts and selected serious-event terms. The deaths field is not reported, and the listed entries do not provide detailed timing, causal attribution, or a complete account of participant-level event patterns. The record also does not describe the allocation ratio or detailed masking implementation. These gaps do not negate the recorded design, but they constrain independent evaluation of the outcome and safety evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia — NCT01808092.
- Registry record last updated 2017-09-06; status last verified 2017-09.
- Results first posted 2017-02-03.
- 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 registry record describes a completed Phase III, randomized, multicentre, double-blind, double-dummy, parallel-group study of intravenous ceftazidime-avibactam versus intravenous meropenem in hospitalized adults with nosocomial pneumonia, including ventilator-associated pneumonia. Enrollment was 969. The listed primary endpoint was clinical cure at the test-of-cure visit, Day 21 to 25, in the clinical modified intent-to-treat population, and was designated co-primary.
The endpoint definition and analysis-population criteria are reported, but the primary group counts, denominators, comparative effect estimate, confidence interval, and p-value are not reported in the registry record. The record lists 2 analyses and 49 outcome measures. Safety entries report serious and other adverse-event counts for both groups and selected serious-event terms with percentages; deaths are not reported.
The study question and design can be described, but the primary comparative result and its statistical precision cannot be assessed from the registry record.