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The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese adults. This study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertapenem sodium 1 g | Experimental | Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose |
|
| Ceftriaxone sodium 2 g | Active Comparator | Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ertapenem sodium | Drug | Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Success of Prophylaxis | Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy | From study drug dose (day of surgery) up to 4 weeks post therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Favorable Clinical Response | Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection | 4 weeks posttreatment |
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Inclusion Criteria:
- Participant is scheduled to undergo elective colon or colorectal surgery by
laparotomy that is scheduled in advance with adequate time prior to surgery to
complete preoperative bowel preparation.
- Participant is a Chinese adult between the ages of more than 18 years old and
less than 81 years old.
- Participant is highly unlikely to conceive.
Exclusion Criteria:
ulcerative colitis or Crohn's disease).
immunosuppressive therapy, or use of high-dose corticosteroids.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25151205 | Result | Leng XS, Zhao YJ, Qiu HZ, Cao YK, Zhu WH, Shen JF, Paschke A, Dai WM, Caldwell N, Wang J. Ertapenem prophylaxis of surgical site infections in elective colorectal surgery in China: a multicentre, randomized, double-blind, active-controlled study. J Antimicrob Chemother. 2014 Dec;69(12):3379-86. doi: 10.1093/jac/dku302. Epub 2014 Aug 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ertapenem | Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose |
| FG001 | Ceftriaxone/Metronidazole | Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ertapenem | Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose |
| BG001 | Ceftriaxone/Metronidazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Success of Prophylaxis | Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy | Primary analysis results are for "evaluable-patients-only", defined as patients who received a complete dose of prophylaxis, underwent elective colorectal surgery with completion of bowel preparation procedure, had primary skin closure of the wound, and did not receive any prohibited systemic antibiotics or other prohibited anti-infective agents. | Posted | Number | 95% Confidence Interval | percentage of participants | From study drug dose (day of surgery) up to 4 weeks post therapy |
|
Up to and including 28 days after last administration of study drug
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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 | Ertapenem | Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naimi Missoum | Merck Sharp & Dohme (China) Ltd. | +8621 2211 8546 | naimi_missoum@merck.com |
| ID | Term |
|---|---|
| D007239 | Infections |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| C108047 | L 749345 |
| D002443 | Ceftriaxone |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
| ceftriaxone sodium | Drug | Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision |
|
|
| placebo to metronidazole | Drug | Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision |
|
| metronidazole | Drug | Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision |
|
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Ceftriaxone/Metronidazole | Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose |
|
|
|
| Secondary | Percentage of Participants With Favorable Clinical Response | Percentage of participants who have no signs or symptoms of infection at the surgical site and do not require surgical intervention for infection | Population analyzed was participants who had no signs or symptoms of infection at the surgical site and did not require surgical intervention for infection. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks posttreatment |
|
|
|
|
| 6 |
| 290 |
| 23 |
| 290 |
| EG001 | Ceftriaxone/Metronidazole | Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose | 14 | 297 | 18 | 297 |
| Cardiac Failure Acute | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
|
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 14.0 | Systematic Assessment |
|
| Incision Site Infection | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Pelvic Abscess | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
|
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Anastomotic Fistula | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Anastomotic Leak | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
|
| Vocal Cord Paralysis | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
|
| Embolism Venous | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
| Venous Thrombosis Limb | Vascular disorders | MedDRA 14.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |