Trial · NCT03830333
Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
NCT03830333, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-10-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015). Trials, record NCT03830333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03830333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015)
- NCT number
- NCT03830333
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 268 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Complicated Intra-abdominal Infections
- Interventions
- Ceftolozane/Tazobactam, Metronidazole, Meropenem, Placebo
- First posted
- 2019-02-05
- Last updated
- 2023-01-17
- Results first posted
- 2021-10-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | Up to approximately Day 30 | Clinical response was classified as "cure" or "failure". Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. The percentage of participants with clinical response of clinical cure or clinical failure at TOC was summarized. |
| Secondary | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Up to approximately Day 30 | Clinical response was classified as "cure", "failure", or "indeterminate". Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate (unfavorable) was defined as participants for whom study data were not available for evaluation of efficacy for any reason. The percentage of participants with clinical response of clinical cure, clinical failure, or indeterminate at TOC was summarized. |
| Secondary | Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at End of Therapy (EOT) Visit: CE Population | Up to approximately Day 15 | Clinical response was classified as "cure" or "failure". Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. The percentage of participants with clinical response of clinical cure or clinical failure at EOT was summarized. |
| Secondary | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at EOT Visit: ITT Population | Up to approximately Day 15 | Clinical response was classified as "cure", "failure", or "indeterminate". Clinical cure (favorable) was defined as complete resolution or significant improvement in signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure is required for the index infection. Clinical failure (unfavorable) was defined as death related to IAI at any time point; persisting or recurrent infection within the abdomen requiring additional intervention to cure; need for treatment with additional antibiotics for ongoing IAI symptoms; or post-surgical wound infection that requires additional antimicrobial therapy and/or non-routing wound care. Indeterminate (unfavorable) was defined as participants for whom study data are not available for evaluation of efficacy for any reason. The percentage of participants with clinical response of clinical cure, clinical failure, or indeterminate at EOT was summarized. |
| Secondary | Percentage of Participants With Favorable Per-Participant Microbiological Response of Eradication or Presumed Eradication at TOC Visit: Expanded Microbiologically Evaluable (EME) Population | Up to approximately Day 30 | An overall microbiological response was determined by the Sponsor for each participant based on individual microbiological responses for each baseline bacterial pathogen. A favorable individual microbiological response was eradication (absence of the baseline bacterial pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a participant who is assessed as a clinical cure). In order for the participant to have a favorable overall microbiological response, each individual baseline bacterial pathogen must have had a favorable microbiological outcome. The percentage of participants with a favorable per-participant microbiological response of eradication or presumed eradication was reported for the TOC visit. |
| Secondary | Percentage of Participants With Favorable Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the TOC Visit: EME Population | Up to approximately Day 30 | A microbiological response was determined for each bacterial pathogen isolated at baseline by the Sponsor. Favorable microbiological responses included eradication (absence of the baseline bacterial pathogen in a specimen appropriately obtained from the original site of infection) or presumed eradication (absence of material to culture in a participant who is assessed as a clinical cure). The percentage of participants with a favorable microbiological response of eradication or presumed eradication was reported per pathogen for the TOC visit. |
| Secondary | Percentage of Participants Who Experienced 1 or More Adverse Events (AEs) | Up to approximately Day 30 | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The percentage of participants who experienced 1 or more AEs were summarized. |
| Secondary | Percentage of Participants That Discontinued Study Treatment Due to an AE | Up to Day 14 | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product that did not necessarily have to have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The percentage of participants who had study drug discontinued during the study due to an AE was summarized. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | Up to approximately Day 30 | All participants of the CE population who met the protocol definition of cIAI, had no significant protocol deviations, received the minimum duration of randomized IV study therapy, and had an efficacy assessment of cure or failure at the TOC visit were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Up to approximately Day 30 | The ITT population consisted of all randomized participants. Participants in the ITT population were analyzed based on the treatment they were randomized to, irrespective of what they actually received. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at End of Therapy (EOT) Visit: CE Population | Up to approximately Day 15 | All participants of the CE population who met the protocol definition of cIAI, had no significant protocol deviations, received the minimum duration of randomized IV study therapy, and had an efficacy assessment of cure or failure at the EOT visit were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at EOT Visit: ITT Population | Up to approximately Day 15 | The ITT population consisted of all randomized participants. Participants in the ITT population were analyzed based on the treatment they were randomized to, irrespective of what they actually received. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Per-Participant Microbiological Response of Eradication or Presumed Eradication at TOC Visit: Expanded Microbiologically Evaluable (EME) Population | Up to approximately Day 30 | The EME population consisted of all randomized participants who had cIAI as evidenced by identification of at least 1 baseline intra-abdominal pathogen, regardless of susceptibility to study drug and met all CE population criteria. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Favorable Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the TOC Visit: EME Population | Up to approximately Day 30 | The EME population consisted of all randomized participants with data available who had cIAI as evidenced by identification of at least 1 baseline intra-abdominal pathogen, regardless of susceptibility to study drug and met all CE population criteria. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced 1 or More Adverse Events (AEs) | Up to approximately Day 30 | The All Participants as Treated (APaT) population was used for the analysis of safety data in this study. The APaT population consisted of all randomized participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants That Discontinued Study Treatment Due to an AE | Up to Day 14 | The APaT population was used for the analysis of safety data in this study. The APaT population consisted of all randomized participants who received at least one dose of study treatment. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | Ceftolozane/Tazobactam + Metronidazole | Clinical Cure (favorable) | 95.2 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | Meropenem + Placebo | Clinical Cure (favorable) | 93.1 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | Ceftolozane/Tazobactam + Metronidazole | Clinical Failure (unfavorable) | 4.8 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | Meropenem + Placebo | Clinical Failure (unfavorable) | 6.9 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Ceftolozane/Tazobactam + Metronidazole | Clinical Cure (favorable) | 85.1 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Meropenem + Placebo | Clinical Cure (favorable) | 89.6 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Ceftolozane/Tazobactam + Metronidazole | Clinical Failure (unfavorable) | 14.2 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Meropenem + Placebo | Clinical Failure (unfavorable) | 9.7 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Ceftolozane/Tazobactam + Metronidazole | Indeterminate (unfavorable) | 0.7 | Percentage of Participants | |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | Meropenem + Placebo | Indeterminate (unfavorable) | 0.7 | Percentage of Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ceftolozane/Tazobactam + Metronidazole | 134 | |
| Overall Study | STARTED | Meropenem + Placebo | 134 | |
| Overall Study | Clinically Evaluable Population | Ceftolozane/Tazobactam + Metronidazole | 105 | |
| Overall Study | Clinically Evaluable Population | Meropenem + Placebo | 116 | |
| Overall Study | COMPLETED | Ceftolozane/Tazobactam + Metronidazole | 126 | |
| Overall Study | COMPLETED | Meropenem + Placebo | 130 | |
| Overall Study | NOT COMPLETED | Ceftolozane/Tazobactam + Metronidazole | 8 | |
| Overall Study | NOT COMPLETED | Meropenem + Placebo | 4 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Ceftolozane/Tazobactam + Metronidazole | 1 | 134 | 1 |
| other | Constipation | Gastrointestinal disorders | Meropenem + Placebo | 8 | 134 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Ceftolozane/Tazobactam + Metronidazole | 8 | 134 | 8 |
| other | Diarrhoea | Gastrointestinal disorders | Meropenem + Placebo | 11 | 134 | 12 |
| other | Pyrexia | General disorders | Ceftolozane/Tazobactam + Metronidazole | 9 | 134 | 11 |
| other | Pyrexia | General disorders | Meropenem + Placebo | 14 | 134 | 15 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Ceftolozane/Tazobactam + Metronidazole | 7 | 134 | 7 |
| other | Hypokalaemia | Metabolism and nutrition disorders | Meropenem + Placebo | 2 | 134 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ceftolozane/Tazobactam + Metronidazole | 7 | 134 | 7 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Meropenem + Placebo | 9 | 134 | 9 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ceftolozane/Tazobactam + Metronidazole | 0 | 134 |
| Total, all-cause mortality | Meropenem + Placebo | 1 | 134 |
| Total, other adverse events | Ceftolozane/Tazobactam + Metronidazole | 28 | 134 |
| Total, other adverse events | Meropenem + Placebo | 33 | 134 |
| Total, serious adverse events | Ceftolozane/Tazobactam + Metronidazole | 7 | 134 |
| Total, serious adverse events | Meropenem + Placebo | 7 | 134 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ceftolozane/Tazobactam + Metronidazole vs Meropenem + Placebo: deaths from any cause | Trial comparisons |
| Ceftolozane/Tazobactam + Metronidazole vs Meropenem + Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03830333
GET https://conductscience.org/api/trials/v1/NCT03830333/results?page=2