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This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tigecycline | Drug | every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population | The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons). | Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
| Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population | The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons). | Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population | The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anqing City Hospital | Anqing | Anhui | 246003 | China | ||
| Department of Hepatobiliary Surgery, Peking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30584308 | Derived | Chen Y, Zhu D, Zhang Y, Zhao Y, Chen G, Li P, Xu L, Yan P, Hickman MA, Xu X, Tawadrous M, Wible M. A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China. Ther Clin Risk Manag. 2018 Nov 30;14:2327-2339. doi: 10.2147/TCRM.S171821. eCollection 2018. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Of the total of 470 participants randomized, 235 were randomized to each treatment group. Seven participants (4 in tigecycline group and 3 in imipenem/cilastatin group) did not receive study treatment. One participant was randomized to imipenem/cilastatin group but received tigecycline and was reported and analyzed under the tigecycline group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tigecycline 50mg | Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Imipenem/cilastatin | Drug | every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment. |
|
| Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
| Microbiological Response at the Subject Level in the ME Population at the TOC Assessment | The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection. | Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
| From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy) |
| Xicheng District |
| Beijing Municipality |
| 100044 |
| China |
| Zhongshan Hospital Xiamen University | Xiamen | Fujian | 361004 | China |
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | Fujian | 363000 | China |
| Department of General Surgery, the First Affiliated Hospital Of Guangzhou Medical University | Guangzhou | Guangdong | 510120 | China |
| The First Affiliated Hospital of JiNan University/General Surgery | Guangzhou | Guangdong | 510630 | China |
| The First Hospital of Shantou University School of Medicine | Shantou | Guangdong | 515041 | China |
| Shenzhen Second People's Hosptial/Department of hepatobiliary surgery | Shenzhen | Guangdong | 518039 | China |
| Affiliated Hospital of Guilin Medical University | Guilin | Guangxi | 541001 | China |
| HaiKou Municipal People's Hospital | Haikou | Hainan | 570208 | China |
| Hainan Provincial People's Hospital | Haikou | Hainan | 570311 | China |
| The Third People's Hospital of Hainan Province/department of general surgery | Sanya | Hainan | 572000 | China |
| Tongji Medical College, Huazhong University of Science and Technology, The Central Hospital of Wuhan | Wuhan | Hubei | 430014 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Zhongnan Hospital of Wuhan University/Intensive Care Unit | Wuhan | Hubei | 430071 | China |
| Xiangya Hospital Central-South University/General Surgery | Changsha | Hunan | 410008 | China |
| The Third Xiangya Hospital of Central South University/Department of General Surgery | Changsha | Hunan | 410013 | China |
| The Third Hospital of Changsha/Department of Surgery | Changsha | Hunan | 410015 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | 014000 | China |
| The Affiliated Jiangyin Hospital of Southeast University Medical College, General Surgery Department | Jiangyin | Jiangsu | 214400 | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| Yangzhou No.1 People's Hospital | Yangzhou | Jiangsu | 225001 | China |
| Jilin Province People's Hospital | Changchun | Jilin | 130021 | China |
| The First Hospital of Jilin University/Surgery | Changchun | Jilin | 130021 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130041 | China |
| Qinghai Provincial People's Hospital | Xining | Qinghai | 810007 | China |
| Binzhou Medical University Hospital | Binzhou | Shandong | 256603 | China |
| Shanghai Fengxian District Central Hospital, Department of Surgery | Shanghai | Shanghai Municipality | 201400 | China |
| Department of General Surgery, Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| General Hospital of Chengdu Military Region of PLA | Chengdu | Sichuan | 610083 | China |
| First people's Hospital of Kunming | Kunming | Yunnan | 650011 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| Taizhou Hospital of Zhejiang Province | Linhai | Zhejiang | 317000 | China |
| Lishui People's Hospital/Intensive Care Unit | Lishui | Zhejiang | 323000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| China Meitan General Hospital/General Surgery Department | Beijing | 100028 | China |
| Department of General Surgery,Beijing Shijitan Hospital,Capital Medical University | Beijing | 100038 | China |
| Navy General Hospital PLA China/Genaral Surgery Department | Beijing | 100048 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| Department of General Surgery, Peking Union Medical College Hospital | Beijing | 100730 | China |
| Institute of Antibiotics, Hua Shan Hospital, Fudan University | Shanghai | 200040 | China |
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200092 | China |
| Zhongshan Hospital Affiliated to Fudan University Qingpu Branch, Department of Surgery, | Shanghai | 201700 | China |
| Tianjin Union Medical Center | Tianjin | 300000 | China |
| Department of General Surgery, Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| Tianjin Nankai Hospital | Tianjin | 300100 | China |
| Imipenem/Cilastatin |
Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tigecycline 50mg | Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline. |
| BG001 | Imipenem/Cilastatin | Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin. |
| 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 |
|
| 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 | Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population | The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons). | The CE population was defined as all clinical modified intent-to-treat (c-mITT) participants who satisfied clinical evaluability criteria and had no major protocol violations. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population | The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons). | The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Microbiological Response at the Subject Level in the ME Population at the TOC Assessment | The microbiological response at the subject level was described according to the following definitions of efficacy. Eradication (documented or presumed): none of the baseline pathogens were present in repeat intra-abdominal cultures from the original site of infection taken during the study or a clinical response of cure precluded the necessity of a repeat intra-abdominal culture. Persistence (documented or presumed): documented: any baseline intra-abdominal pathogen was present in the cultures obtained from the original site of the intra-abdominal abscess, peritonitis, or surgical wound infection during the study; Presumed: repeat microbiological data were not obtained for a participant with a clinical response of failure. Superinfection: Emergence of a new pathogen during therapy, at the site of infection with emergence or worsening of clinical signs and symptoms of infection. | The ME population was defined as all CE participants who satisfied the pre-specified ME evaluable criteria. n=number of participants with each microbiological response. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
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| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (AEs) by Relationship and Seriousness | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both AEs and Non-SAEs. | Safety population included all participants who received at least 1 dose of investigational product. There was 1 participant (who was included in the safety population) had 7 AEs including 1 SAE which were identified after database release and were not reflected in the table. | Posted | Number | participants | From the first dose of study treatment through post therapy follow-up (28 days after the last dose of therapy) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population | The clinical response was to be determined by the investigator and was classified as 1 of the following: cure (relevant clinical signs and symptoms of infection at baseline disappeared or recovered to normal and relevant non microbiological results of laboratory tests returned to normal level or the resolution of signs and symptoms so that at no further therapy was required), failure (participant required additional surgical or radiologic intervention and/or received additional anti-infection therapy to cure the infection since administration of study drug until TOC; or death after study Day 2 due to the infection or a treatment related AE or discontinuation due to a treatment related AE or received greater than 120% of the prescribed number of investigational product doses), or indeterminate (lost to follow-up; or died within 2 days after the first dose of study drug for any reason; or died after study Day 2 but prior to the TOC assessment because of non infection related reasons). | The MITT population was defined as all randomized participants who received at least 1 dose of investigational product. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 3, Day 14 or last day of therapy (treatment duration was at least 5 days and up to 14 days), and TOC (14-21 days after the last dose of therapy) |
|
From the first dose of study treatment (for non-serious AEs)/the time that the subject provided informed consent (for SAEs) through post therapy follow-up (28 days after the last dose of therapy)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tigecycline 50mg | Participants were administered with tigecycline every 12 hours (an initial intravenous [IV] dose of 100 mg followed by 50 mg twice a day [BID] approximately every 12 hours) and placebo (100-mL of normal saline) IV doses every 12 hours beginning 6 hours after the initial IV dose of tigecycline. | 32 | 232 | 57 | 232 | ||
| EG001 | Imipenem/Cilastatin | Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin. | 16 | 232 | 34 | 232 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| D000077728 | Cilastatin, Imipenem Drug Combination |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D015378 | Imipenem |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D015377 | Cilastatin |
| D003521 | Cyclopropanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| OG001 | Imipenem/Cilastatin | Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin. |
|
|
|
| OG001 | Imipenem/Cilastatin | Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin. |
|
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|
| OG001 | Imipenem/Cilastatin | Participants were administered with imipenem/cilastatin (approximately 100-mL IV infusion) intravenously approximately every 6 hours. IV placebo (100 mL of normal saline) was required to be dosed immediately After the first dose of imipenem/cilastatin. |
|
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