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 Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777) (NCT05645757), a randomized phase 1 study. The primary outcome is Number of Participants With Treatment-Emergent Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05645757 |
| Phase | Phase 1 |
| Condition | Bacterial Infection |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | Triple |
| Enrollment | 54 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Results posted | Yes |
2. Clinical Question
The study asks whether single daily doses over 7 days of intravenous ertapenem and zidebactam, given alone or together at escalating dose levels, are associated with treatment-emergent adverse events in healthy adults. It also includes pharmacokinetic objectives, but the registry record does not report their results in the information described.
Population
The brief summary describes healthy adult male and female subjects aged 18 to 45 years old, inclusive. The registry enrollment is 54, while the brief summary describes 52 subjects; the registry record does not explain this difference.
Intervention
Three cohorts received ertapenem with zidebactam as WCK 6777, at the listed dose levels of 1 g plus 1 g, 2 g plus 2 g, or 3 g plus 3 g. Other cohorts received ertapenem alone or zidebactam alone at escalating dose levels.
Comparator
Placebo was included in the combination and standalone ertapenem cohorts. The two standalone zidebactam cohorts had no placebo participants. The registry record describes the study as placebo-controlled, with this exception.
Primary question
The primary endpoint counts participants with treatment-emergent adverse events from Day 1 through Day 11. The registry describes these events by dose group and MedDRA System Organ Class.
This is a safety and tolerability question, not a test of clinical benefit in people with bacterial infection. Although bacterial infection is listed as a condition, the participants described in the brief summary were healthy adults. The study also assessed pharmacokinetic measures for ertapenem and zidebactam after Dose 1.
3. Trial Design
The registry identifies this as a randomized Phase 1 study with a factorial model and triple masking. Its official title describes a double-blind, placebo-controlled, dose-escalation study. The brief summary says the study was single-center and double-blinded in all cohorts except the two standalone zidebactam cohorts. The registry record does not explain the difference between the triple-masking classification and the double-blinding descriptions, or specify which roles were masked.
Seven cohorts were planned. WCK 6777 was evaluated in Cohorts 1, 4 and 7, each described as having 8 participants, with 6 receiving the study drug combination and 2 receiving placebo. Ertapenem alone was evaluated in Cohorts 2 and 5, also described as having 8 participants each, with 6 receiving ertapenem and 2 placebo. Cohorts 3 and 6 evaluated zidebactam alone and each were described as having 6 participants; neither included placebo.
The listed regimens were given by intravenous infusion once daily for 7 days. The infusion duration varied by cohort: 30 (±5) minutes, 1 hour, or 2 hours, as described in the cohort details. The primary endpoint timeframe was Day 1 through Day 11. The study status is completed. The registry lists a start date of 2023-04-19 and a primary completion date of 2023-11-03.
The registry enrollment is 54, whereas the brief summary says the study involved 52 subjects. Those figures are both retained in the record, and the reason for the difference is not reported in the registry record. Allocation procedures, dose-escalation decision rules, and any criteria for moving between dose levels are not reported in the registry record.
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.
Only the first 6 of 8 groups are shown.
Overall Study
| Stage | Cohort 1 - WCK 6777 2 g | Cohort 2 - ERT 2 g | Cohort 3 - ZID 2 g | Cohort 4 - WCK 6777 4 g | Cohort 5 - ERT 3 g | Cohort 6 - ZID 3 g |
|---|---|---|---|---|---|---|
| STARTED | 6 | 6 | 6 | 6 | 7 | 7 |
| COMPLETED | 6 | 6 | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 1 | 1 |
Reasons for not completing this period:
| Reason | Cohort 1 - WCK 6777 2 g | Cohort 2 - ERT 2 g | Cohort 3 - ZID 2 g | Cohort 4 - WCK 6777 4 g | Cohort 5 - ERT 3 g | Cohort 6 - ZID 3 g |
|---|---|---|---|---|---|---|
| Enrolled but treatment not administered | 0 | 0 | 0 | 0 | 1 | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety Population: All participants that received any amount of study drug(s).
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.
Only the first 6 of 9 groups are shown.
| Characteristic | Unit | Cohort 1 - WCK 6777 2 g | Cohort 2 - ERT 2 g | Cohort 3 - ZID 2 g | Cohort 4 - WCK 6777 4 g | Cohort 5 - ERT 3 g | Cohort 6 - ZID 3 g |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 6 | 6 | 6 | 7 | 7 | |
| Age, Continuous | years | 33.7 (SD 7.3) | 35.2 (SD 9.2) | 32.3 (SD 9.5) | 33.2 (SD 7.0) | 33.6 (SD 7.9) | 37.3 (SD 5.6) |
| Sex: Female, Male: Female | Participants | 2 | 3 | 2 | 3 | 2 | 2 |
| Sex: Female, Male: Male | Participants | 4 | 3 | 4 | 3 | 5 | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 1 | 0 | 1 | 2 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 5 | 6 | 5 | 5 | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 1 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 | 4 | 2 | 1 | 2 | 2 |
| Race (NIH/OMB): White | Participants | 0 | 2 | 4 | 5 | 4 | 5 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| BMI | kg/m2 | 27.08 (SD 2.93) | 28.57 (SD 2.05) | 25.18 (SD 3.38) | 27.63 (SD 2.85) | 23.83 (SD 1.62) | 27.27 (SD 2.76) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment-Emergent Adverse Events, measured over Day 1 through Day 11.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with treatment-emergent adverse events during Day 1 through Day 11. The registry defines an adverse event as an untoward medical occurrence after administration of a pharmaceutical product, regardless of whether it is considered related to that product. The definition includes unfavorable signs, abnormal laboratory findings, symptoms, or diseases temporally associated with product use.
The endpoint is expressed as a participant count, with results described by dose group and MedDRA System Organ Class. A participant count answers how many people in each group experienced an event; it does not by itself describe how many events each person experienced, the duration or severity of events, or whether investigators attributed them to treatment. Those details are not reported in the registry record for the primary outcome.
In general, safety endpoints of this kind are used to characterize the types and frequency of events observed during a defined observation period. Including events regardless of causal attribution helps capture occurrences temporally associated with treatment without assuming that treatment caused them. In a small early-phase study, such counts are descriptive: they can identify events observed during exposure, but they do not by themselves establish comparative safety or rule out uncommon harms.
The primary outcome description names treatment-emergent adverse events by dose group and System Organ Class. The posted safety figures separately give participant counts for serious and other adverse events. The registry record does not provide a single combined primary endpoint result or a statistical comparison across the seven cohorts.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted safety figures report no participants with serious adverse events in any of the seven active-treatment cohorts or the placebo group. They also report no deaths in any group. For other adverse events, the recorded affected-participant counts vary across cohorts: the two lowest combination or ertapenem cohorts each list 6 of 6 at risk, while the placebo group lists 9 of 10. The zidebactam 2 g cohort lists 5 of 6; the WCK 6777 4 g cohort lists 5 of 6; the ertapenem 3 g cohort lists 4 of 6; the zidebactam 3 g cohort lists 2 of 6; and the WCK 6777 6 g cohort lists 4 of 6. These are descriptive counts, not evidence that a dose or regimen caused the events.
The groups are small and have different structures. Combination and ertapenem cohorts include placebo participants, while the two standalone zidebactam cohorts do not. The figures therefore should not be read as a balanced set of direct comparisons across all treatments. Variation in observed counts can reflect chance, differences between cohorts, or other factors; the registry record does not report an analysis that separates these possibilities.
The primary outcome is defined over Day 1 through Day 11 and is intended to capture participants with treatment-emergent events. However, the posted figures distinguish serious from other adverse events, and the registry record does not present a consolidated treatment-emergent adverse-event count by System Organ Class in the information described. No confidence intervals, p-values, adjusted comparisons, or estimates of treatment effects are reported in the registry record. Accordingly, the counts do not quantify the precision of differences between groups.
The secondary outcomes concern plasma pharmacokinetics after Dose 1, including maximum, minimum, and predicted end-of-interval concentrations; time to maximum and minimum concentration; and several area-under-the-curve measures. The registry lists these outcomes, but numerical pharmacokinetic results are not reported in the registry record. The presence of those objectives does not support conclusions about drug exposure from the safety counts.
The study is identified as Phase 1 and enrolled healthy adults, so its results describe the reported safety observations in that study population and follow-up period. They do not establish what would occur in people being treated for bacterial infection. The registry record gives no formal comparative analysis, and the absence of reported serious events in these groups should be interpreted as an observed count, not as proof that serious events cannot occur.
9. Statistical Methods Explained
The primary outcome is a count of participants with an event, rather than a continuous measurement such as a laboratory value. For a count endpoint, the basic descriptive information is the number of participants affected and the number assessed or at risk in each group. The posted safety figures use that form for serious and other adverse events. A count is easy to interpret as an observed number of people, but it does not communicate uncertainty on its own.
General statistical explanation: a confidence interval expresses the range of values reasonably compatible with the data under a specified method. For event counts in small groups, an interval can be wide even when the observed count is low or zero. The registry record does not report confidence intervals for the primary outcome or the adverse-event counts. It also does not report p-values or a model-based comparison. Without those, the posted counts should be read descriptively rather than as estimates demonstrating a difference between treatments.
The groups are dose cohorts, not a single two-arm comparison. The combination and standalone ertapenem cohorts include placebo allocations, whereas the standalone zidebactam cohorts have no placebo. This structure matters: a direct comparison requires a clearly specified pair of groups and an analysis appropriate to the allocation and endpoint. The registry record does not report a prespecified primary comparison, a model for the seven cohorts, or an adjustment for differences in dose and treatment composition. No adjusted treatment-effect estimate is reported.
General statistical explanation: randomization can support fair comparisons when allocation and analysis are appropriately conducted, but it does not make every comparison among multiple cohorts automatically interpretable. With several groups, the analysis needs to specify which comparisons answer the main question and how uncertainty is handled. That statistical plan is not reported in the registry record. The factorial model classification alone does not describe the actual analysis or establish which treatment effects were estimated.
The study also lists pharmacokinetic outcomes. Maximum and minimum observed concentrations describe the highest and lowest measured plasma concentrations over the stated measurement scheme. Ctau is a predicted concentration at the end of the dosing interval. Tmax and Tmin describe the times associated with maximum and minimum concentrations. Area-under-the-curve outcomes summarize concentration over time, while dose-normalized maximum concentration expresses maximum concentration relative to dose. General statistical explanation: these measures can characterize exposure and its timing, but their interpretation depends on the sampling schedule, assay details, analysis population, and calculation methods. These details and the numerical pharmacokinetic results are not reported in the registry record.
The sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the stated effect to detect is a fraction of the observed effect. Those assumptions do not constitute the trial's own design justification. No numerical sample-size illustration is reported in the registry record, and no protocol sample-size justification is reported in the registry record. Any such planning illustration is not observed power and should not be treated as a finding about the completed study.
General statistical explanation: power is a design property tied to a specified effect, variability, significance threshold, and analysis. Retrospective calculations based on an observed effect do not show the probability that the trial detected a true effect. For safety outcomes in small cohorts, precision and the range of plausible event rates are often more informative than a binary declaration of significance, but no such interval estimates are reported for these figures.
The registry lists 52 outcome measures and 0 analyses. The registry record does not provide outcome-level statistical methods, missing-data procedures, interim-analysis plans, or a multiplicity strategy. The available information therefore supports a descriptive reading of the reported counts, not reconstruction of an inferential analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 52 outcome measures, including the primary adverse-event endpoint and multiple pharmacokinetic outcomes. It does not report a multiplicity strategy for considering several outcomes or comparisons. In general, when many hypotheses are tested, the chance of at least one apparently unusual result can increase; planned prioritization or statistical adjustment can help define how such results should be interpreted. Whether any such approach was used is not reported in the registry record.
The registry identifies the safety population as all participants who received any amount of study drug. This is a treatment-exposed population, not necessarily the same as every randomized participant. The reported adverse-event figures show 6 at risk in each active cohort and 10 in placebo. The registry record does not explain the difference between those safety-group totals and the enrollment or cohort descriptions, nor does it describe participant flow, exclusions, or reasons for any missing outcome data.
Missing-data handling, censoring rules, and the approach to participants with incomplete follow-up are not reported in the registry record. The registry also does not report whether all participants completed the observation period or whether event ascertainment differed by cohort. These details matter because event counts depend on the population observed and the completeness of follow-up.
No interim-analysis plan, stopping rule, or statistical analysis plan is reported in the registry record. The brief summary describes dose escalation, but the rules governing escalation are not reported in the registry record. Without these details, the available account does not establish how multiplicity, missing observations, or decision-making across dose levels was handled.
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 |
|---|---|---|---|
| Cohort 1 - WCK 6777 2 g | 0 | 6 | 0.0% |
| Cohort 2 - ERT 2 g | 0 | 6 | 0.0% |
| Cohort 3 - ZID 2 g | 0 | 6 | 0.0% |
| Cohort 4 - WCK 6777 4 g | 0 | 6 | 0.0% |
| Cohort 5 - ERT 3 g | 0 | 6 | 0.0% |
| Cohort 6 - ZID 3 g | 0 | 6 | 0.0% |
| Cohort 7 - WCK 6777 6 g | 0 | 6 | 0.0% |
| Placebo | 0 | 10 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1 - WCK 6777 2 g | 0 of 6 |
| Cohort 2 - ERT 2 g | 0 of 6 |
| Cohort 3 - ZID 2 g | 0 of 6 |
| Cohort 4 - WCK 6777 4 g | 0 of 6 |
| Cohort 5 - ERT 3 g | 0 of 6 |
| Cohort 6 - ZID 3 g | 0 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort 1 - WCK 6777 2 g | 6 of 6 |
| Cohort 2 - ERT 2 g | 6 of 6 |
| Cohort 3 - ZID 2 g | 5 of 6 |
| Cohort 4 - WCK 6777 4 g | 5 of 6 |
| Cohort 5 - ERT 3 g | 4 of 6 |
| Cohort 6 - ZID 3 g | 2 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1 - WCK 6777 2 g | Cohort 2 - ERT 2 g | Cohort 3 - ZID 2 g | Cohort 4 - WCK 6777 4 g | Cohort 5 - ERT 3 g | Cohort 6 - ZID 3 g |
|---|---|---|---|---|---|---|---|
| Infusion site erythema | General disorders | 0 of 6 | 2 of 6 | 3 of 6 | 1 of 6 | 1 of 6 | 1 of 6 |
| Infusion site extravasation | General disorders | 1 of 6 | 0 of 6 | 0 of 6 | 2 of 6 | 2 of 6 | 0 of 6 |
| Infusion site pain | General disorders | 1 of 6 | 2 of 6 | 1 of 6 | 0 of 6 | 0 of 6 | 0 of 6 |
| Headache | Nervous system disorders | 1 of 6 | 1 of 6 | 1 of 6 | 0 of 6 | 1 of 6 | 0 of 6 |
| Diarrhoea | Gastrointestinal disorders | 0 of 6 | 2 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 6 |
| Nausea | Gastrointestinal disorders | 2 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 |
| Anaemia | Blood and lymphatic system disorders | 0 of 6 | 1 of 6 | 1 of 6 | 0 of 6 | 0 of 6 | 0 of 6 |
| Infusion site phlebitis | General disorders | 0 of 6 | 1 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 0 of 6 |
| Infusion site pruritus | General disorders | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 1 of 6 | 0 of 6 |
| Infusion site swelling | General disorders | 0 of 6 | 1 of 6 | 1 of 6 | 0 of 6 | 0 of 6 | 0 of 6 |
The serious adverse-event figures show 0 affected participants among 6 at risk in each active-treatment cohort and 0 among 10 at risk in placebo. The registry also lists 0 deaths in every group. The serious-event terms list is empty. These figures describe what was recorded during the study; they do not establish that the risk of a serious event is zero.
Other adverse events were recorded in all groups. The affected counts were 6 of 6 in Cohort 1, 6 of 6 in Cohort 2, 5 of 6 in Cohort 3, 5 of 6 in Cohort 4, 4 of 6 in Cohort 5, 2 of 6 in Cohort 6, 4 of 6 in Cohort 7, and 9 of 10 in placebo. These are numbers of participants affected, not numbers of separate events.
General statistical explanation: when groups are small, zero observed serious events still leaves uncertainty about the frequency of events that might occur in a larger population or over a longer period. Also, counts across different dose cohorts should not be treated as a controlled comparison unless a suitable comparison and analysis are specified. No such statistical comparison is reported in the registry record.
12. What the Result Does, and Does Not, Mean
The findings establish that the posted registry results include no serious adverse events or deaths among the listed participants at risk in the seven active-treatment cohorts and placebo. They also show that other adverse events were recorded in each group, with the affected-participant counts varying by cohort. These are observations within the study's Day 1 through Day 11 primary endpoint timeframe, not estimates of longer-term risk.
They do not establish that any regimen caused the other adverse events, or that differences in the counts reflect a dose-related pattern. The cohorts are small, the standalone zidebactam groups lack placebo, and the registry record does not report statistical comparisons or uncertainty intervals. A numerical contrast between groups would not, by itself, resolve those limitations.
The study's purpose included assessing safety, tolerability, and pharmacokinetics in healthy adults. The adverse-event counts speak only to events recorded in the described study setting and participants. They do not provide evidence about clinical effectiveness, and they do not establish safety in people with bacterial infection. Although pharmacokinetic outcomes are listed, their numerical results are not reported in the registry record.
The record also leaves important details unavailable, including a complete primary-outcome analysis by System Organ Class, participant flow, missing-data handling, dose-escalation rules, and the statistical analysis plan. The enrollment is listed as 54, while the brief summary describes 52 subjects, and the reason is not reported in the registry record. These features limit how fully the reported observations can be interpreted.
In general, early-phase safety findings are best understood as a description of observed events under the studied conditions. Absence of an observed event is not proof that the event is impossible, and an event occurring after treatment is not proof that treatment caused it. The registry results support neither a definitive comparative safety conclusion nor a claim about treatment benefit.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of an early-phase, dose-escalation safety design with combination and single-agent cohorts. It places multiple dose regimens in one study framework and includes placebo in the combination and ertapenem cohorts, while the standalone zidebactam cohorts have no placebo. That structure highlights why the specific comparison matters: not every cohort has the same comparator or allocation pattern.
Safety outcomes are often sparse counts, and this record illustrates why a count needs its denominator and context. The serious-event counts are zero in every listed group, while other adverse events were recorded in each. With small groups, such data describe what occurred but offer limited precision for comparing event frequencies. General statistical explanation: uncertainty intervals and prespecified comparisons help distinguish a clear signal from variation that could plausibly arise by chance; those analyses are not reported in the registry record.
The multiple dose levels and the set of listed outcomes also make prespecification important. A statistical plan can clarify which endpoint is primary, how cohorts are compared, how multiplicity is addressed, and how missing observations are handled. Those details are not reported in the registry record. Consequently, the reported information is most useful as descriptive safety and design context rather than as a basis for inferential claims.
The discrepancy between the registry enrollment of 54 and the brief summary's 52 subjects is another practical lesson in reading trial records. Likewise, the registry's triple-masking classification appears alongside descriptions of double-blinding and exceptions for two cohorts; the record does not reconcile those descriptions. These inconsistencies do not change the event counts, but they affect the clarity of design interpretation.
Finally, the listed pharmacokinetic objectives show that safety studies can collect exposure measures alongside adverse events. Without the numerical pharmacokinetic results, however, the outcome list alone cannot connect exposure patterns to the observed safety counts.
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.
Several record-specific limitations constrain interpretation. The enrollment is listed as 54, while the brief summary describes 52 subjects; the reason for that difference is not reported in the registry record. The safety figures list 6 at risk in each active cohort and 10 in placebo, but the record does not provide a participant-flow account explaining how those analyzed groups relate to enrollment and cohort plans.
The summary describes a single-center study, but details about the site are not reported in the registry record. The registry classifies masking as triple, while the official title and brief summary describe double-blinding, with the summary noting exceptions for the standalone zidebactam cohorts. The roles masked and the reason for the classification difference are not reported in the registry record.
The study includes seven cohorts with different treatments and comparator availability. Placebo was not included in the two standalone zidebactam cohorts. The registry record does not report a prespecified statistical comparison across these groups, a dose-response analysis, or adjustment for multiple comparisons. It also does not report confidence intervals or p-values for the safety counts.
The primary outcome is described by dose group and MedDRA System Organ Class, but the detailed primary endpoint results are not reported in the registry record in the information described. Serious and other adverse-event counts are available, but event-level descriptions, severity and attribution details, and missing-data procedures are not reported in the registry record. The pharmacokinetic outcomes are listed without numerical results. Dose-escalation rules, a sample-size justification, interim analyses, and a statistical analysis plan are not reported in the registry record.
The population described is healthy adults aged 18 to 45 years old, inclusive, and the primary observation period runs through Day 11. The registry record therefore does not establish how the findings extend to other populations or longer observation periods.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777) — NCT05645757.
- Registry record last updated 2025-01-20; status last verified 2022-09-22.
- Results first posted 2024-12-05.
- 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
NCT05645757 is a completed randomized Phase 1 study of intravenous ertapenem, zidebactam, their combination as WCK 6777, and placebo. The registry lists an enrollment of 54; its brief summary describes 52 healthy adult male and female subjects aged 18 to 45 years old, inclusive. Seven cohorts evaluated combination, ertapenem-alone, or zidebactam-alone regimens, with placebo included in the combination and ertapenem cohorts but not the zidebactam-alone cohorts.
The primary outcome counts participants with treatment-emergent adverse events from Day 1 through Day 11. No serious adverse events or deaths are listed in any group. Other adverse events are recorded in each group, with participant counts varying by cohort. The study also lists pharmacokinetic outcomes, but numerical results for those measures are not reported in the registry record.
The registry lists the sponsor as the National Institute of Allergy and Infectious Diseases (NIAID), a start date of 2023-04-19, and a primary completion date of 2023-11-03. Statistical comparisons, confidence intervals, and a detailed analysis plan are not reported in the registry record.