A Prospective, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of a Single Dose of Ertapenem Sodium (MK0826) Versus Cefotetan for the Prophylaxis of Surgical Site Infection Following Elective Colorectal Surgery

Merck Sharp & Dohme LLC0 个研究点目标入组 952 人开始时间: 2002年4月1日最近更新: 2017年2月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 952
主要终点: Surgical site infection following elective colorectal surgery based on surgical site assessment.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.

详细描述

The duration of treatment is 1 day.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female patients 18 years of age scheduled to undergo elective colon or colorectal surgery by laparotomy must meet the following criteria:
•Surgery must be scheduled in advance.
•There must be adequate time to complete preoperative bowel preparation

排除标准

未提供

结局指标

主要结局

Surgical site infection following elective colorectal surgery based on surgical site assessment.

次要结局

Microbiology of surgical site infection in pts who fail prevention or have distant site infection; Safety profile based on AE monitoring and lab results.

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

1 期

A Randomized Placebo-controlled Multicenter Trial to Evaluate the Efficacy and Safety of JTR-161, Allogeneic Human Dental Pulp Stem Cell, in Patients With Acute Ischemic stRoke (J-REPAIR)Acute Ischemic Stroke

NCT04608838Teijin Pharma Limited79

终止

2 期

Phase IIa Clinical Study of N-Rephasin® SAL200Staphylococcus Aureus BacteremiaAnti-Bacterial Agents

NCT03089697Intron Biotechnology, Inc.25

已完成

1 期

Study to Assess the Safety, Tolerability, and Pharmacokinetics of REGN5381 (an NPR1 Agonist) in Adult HumansHealthy

NCT04506645Regeneron Pharmaceuticals90

已完成

1 期

Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)Anthrax

NCT00845650Emergent BioSolutions129

已完成

2 期

Study to Evaluate Analgesic Effect of Intravenous Administration of Kappa Agonist CR845 After Hysterectomy SurgeryAcute Pain

NCT00877799Cara Therapeutics, Inc.114