Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-7625A-015 | Other Identifier | Merck |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the efficacy of ceftolozane/tazobactam (MK-7625A) plus metronidazole versus meropenem in adults diagnosed with complicated intra-abdominal infection (cIAI). The primary hypothesis is ceftolozane/tazobactam plus metronidazole is non-inferior to meropenem, as measured by the clinical response rate at the Test-of Cure (TOC) visit in the Clinically Evaluable (CE) population.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftolozane/Tazobactam + Metronidazole | Experimental | Participants receive ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam may be adjusted to 500 mg/250 mg if creatinine clearance [CrCL] is 30 to ≤50 mL/min) |
|
| Meropenem + Placebo | Active Comparator | Participants receive meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem may be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ceftolozane/Tazobactam | Drug | Ceftolozane 1000 mg / tazobactam 500 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive ceftolozane 500 mg / tazobactam 250 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | 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. | Up to approximately Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital ( Site 0033) | Hefei | Anhui | 230001 | China | ||
| Navy General Hospital ( Site 0009) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35987467 | Result | Sun Y, Fan J, Chen G, Chen X, Du X, Wang Y, Wang H, Sun F, Johnson MG, Bensaci M, Huntington JA, Bruno CJ. A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections. Int J Infect Dis. 2022 Oct;123:157-165. doi: 10.1016/j.ijid.2022.08.003. Epub 2022 Aug 17. | |
| 40913503 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Adult participants with complicated intra-abdominal infection (cIAI) were recruited at 21 study sites in China. Participants with severe impairment of renal function (estimated creatinine clearance [CrCL] <30 mL/min) were excluded.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ceftolozane/Tazobactam + Metronidazole | Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Metronidazole | Drug | Metronidazole 500 mg by IV infusion every 8 hours for 4 to 14 days. |
|
| Meropenem | Drug | Meropenem 1000 mg by IV infusion every 8 hours for 4 to 14 days. Participants with CrCL of 30 to ≤ 50 mL/min will receive IV infusion every 12 hours. |
|
| Placebo | Drug | Saline by IV infusion every 8 hours for 4 to 14 days. |
|
| Up to approximately Day 30 |
| Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at End of Therapy (EOT) Visit: CE Population | 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. | Up to approximately Day 15 |
| Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at EOT Visit: ITT Population | 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. | Up to approximately Day 15 |
| Percentage of Participants With Favorable Per-Participant Microbiological Response of Eradication or Presumed Eradication at TOC Visit: Expanded Microbiologically Evaluable (EME) Population | 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. | Up to approximately Day 30 |
| Percentage of Participants With Favorable Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the TOC Visit: EME Population | 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. | Up to approximately Day 30 |
| Percentage of Participants Who Experienced 1 or More Adverse Events (AEs) | 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. | Up to approximately Day 30 |
| Percentage of Participants That Discontinued Study Treatment Due to an AE | 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. | Up to Day 14 |
| Beijing |
| Beijing Municipality |
| 100048 |
| China |
| Peking University Third Hospital ( Site 0002) | Beijing | Beijing Municipality | 100191 | China |
| The First Affiliated Hospital of Guangzhou Medical University ( Site 0026) | Guangzhou | Guangdong | 510120 | China |
| Hainan General Hospital ( Site 0042) | Haikou | Hainan | 570311 | China |
| Baotou Central Hospital ( Site 0013) | Baotou | Inner Mongolia | 014040 | China |
| The First People's Hospital of Changzhou ( Site 0054) | Changzhou | Jiangsu | 213000 | China |
| Wuxi No.2 People's Hospital ( Site 0050) | Wuxi | Jiangsu | 214002 | China |
| Wuxi People's Hospital ( Site 0020) | Wuxi | Jiangsu | 214023 | China |
| Subei People's Hospital ( Site 0046) | Yangzhou | Jiangsu | 200080 | China |
| Affiliated Hospital of Jiangsu University ( Site 0049) | Zhenjiang | Jiangsu | 212000 | China |
| The First Affiliated Hospital of Nanchang University ( Site 0029) | Nanchang | Jiangxi | 330006 | China |
| The Second Affiliated Hospital of Nanchang University ( Site 0053) | Nanchang | Jiangxi | 330006 | China |
| The Second Hospital of Jilin University ( Site 0048) | Changchun | Jilin | 130022 | China |
| Liaocheng People s hospital ( Site 0014) | Liaocheng | Shandong | 252000 | China |
| Zhongshan Hospital of Fudan University ( Site 0001) | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai General Hospital ( Site 0016) | Shanghai | Shanghai Municipality | 200080 | China |
| Central Hospital of Minhang District ( Site 0052) | Shanghai | Shanghai Municipality | 201100 | China |
| Tianjin People's Hospital ( Site 0040) | Tianjin | Tianjin Municipality | 300121 | China |
| The First Affiliated Hospital of Xinjiang Medical University ( Site 0034) | Ürümqi | Xinjiang | 830054 | China |
| The First Hospital of Kunming ( Site 0041) | Kunming | Yunnan | 650200 | China |
| Taizhou Hospital of Zhejiang Province ( Site 0035) | Taizhou | Zhejiang | 317000 | China |
| The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0051) | Wenzhou | Zhejiang | 325000 | China |
| The First Affiliated Hospital of Wenzhou Medical University ( Site 0015) | Wenzhou | Zhejiang | 325000 | China |
| Southern Medical University Nanfang Hospital ( Site 0055) | Guangzhou | 510515 | China |
| Derived |
| Li Z, Kang Y, Gao H, Zhao Y, Luo D, Wang D, Zhang X, Yu J, Chu G, Cao J, Wang F, Zhao X, Jensen E, Lin G, Chen G. Pooled data from phase 3 clinical trials comparing the clinical activity of ceftolozane/tazobactam versus meropenem for the treatment of complicated intra-abdominal infections. Infect Dis (Lond). 2026 Jan;58(1):40-51. doi: 10.1080/23744235.2025.2544828. Epub 2025 Sep 6. |
| FG001 |
| Meropenem + Placebo |
Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
| Clinically Evaluable Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent to treat (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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ceftolozane/Tazobactam + Metronidazole | Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min). |
| BG001 | Meropenem + Placebo | Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Primary Site of Infection | Primary site of infection consisted of bowel (small or large) and other site of infection. Participants with appendix, stomach, or duodenum as the anatomic site of infection, were stratified to the "other site" group. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at Test of Cure (TOC) Visit: Clinically Evaluable (CE) Population | 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. | 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. | Posted | Number | Percentage of Participants | Up to approximately Day 30 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at TOC Visit: Intent to Treat (ITT) Population | 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. | 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. | Posted | Number | Percentage of Participants | Up to approximately Day 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response (Clinical Cure or Clinical Failure) at End of Therapy (EOT) Visit: CE Population | 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. | 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. | Posted | Number | Percentage of Participants | Up to approximately Day 15 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response (Clinical Cure, Clinical Failure, or Indeterminate) at EOT Visit: ITT Population | 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. | 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. | Posted | Number | Percentage of Participants | Up to approximately Day 15 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Favorable Per-Participant Microbiological Response of Eradication or Presumed Eradication at TOC Visit: Expanded Microbiologically Evaluable (EME) Population | 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. | 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. | Posted | Number | Percentage of Participants | Up to approximately Day 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Favorable Microbiological Response of Eradication or Presumed Eradication, by Pathogen, at the TOC Visit: EME Population | 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. | 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. | Posted | Number | Percentage of Participants | Up to approximately Day 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Experienced 1 or More Adverse Events (AEs) | 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. | 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. | Posted | Number | Percentage of Participants | Up to approximately Day 30 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants That Discontinued Study Treatment Due to an AE | 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. | 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. | Posted | Number | Percentage of Participants | Up to Day 14 |
|
Up to approximately Day 30
The analysis population consisted of all randomized participants who received at least one dose of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ceftolozane/Tazobactam + Metronidazole | Participants received ceftolozane/tazobactam 1500 mg (ceftolozane 1000 mg + tazobactam 500 mg) plus metronidazole 500 mg administered as an intravenous (IV) infusion every 8 hours for 4 to 14 days (per protocol, ceftolozane/tazobactam could be adjusted to 500 mg/250 mg if CrCL was 30 to ≤50 mL/min). | 0 | 134 | 7 | 134 | 28 | 134 |
| EG001 | Meropenem + Placebo | Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). | 1 | 134 | 7 | 134 | 33 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Sep 24, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C000594038 | ceftolozane, tazobactam drug combination |
| D008795 | Metronidazole |
| D000077731 | Meropenem |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other site of infection |
|
| OG001 | Meropenem + Placebo | Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
|
|
|
| OG001 |
| Meropenem + Placebo |
Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
|
|
|
| OG001 | Meropenem + Placebo | Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
|
|
|
| OG001 | Meropenem + Placebo | Participants received meropenem 1000 mg plus saline administered as an IV infusion every 8 hours for 4 to 14 days (per protocol, meropenem could be adjusted to every 12 hours if CrCL was 30 to ≤50 mL/min). |
|
|
|
|
|
|
|
|
|
|
|
|