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Completed

NCT Number: NCT00229060

Doripenem in the Treatment of Complicated Intra-Abdominal Infections

The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.

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Key information

Conditions

Bacterial Infections and Mycoses Appendicitis Biliary Tract Diseases Cecal Diseases Cholecystitis Digestive System Diseases Gallbladder Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections Pancreatic Diseases Pancreatitis Peritoneal Diseases Peritonitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of doripenem versus comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. Doripenem or comparator is administered. The primary endpoint is the clinical response measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has a requirement for surgical intervention within 24 hours of study entry
  • Requirement of antibacterial therapy in addition to surgical intervention in certain intra-abdominal infections

Exclusion criteria

  • Female patients who are pregnant, nursing, or if of child bearing potential not using a medically accepted, effective method of birth control
  • Any rapidly-progressing disease or immediately life-threatening illness

Treatment and study plan

Doripenem

Drug

Primary outcomes

  1. The clinical response measured at late follow-up visit.

Secondary outcomes

  1. The clinical response at early follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory test results) conducted throughout the study.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Industry

Collaborators

  • Peninsula Pharmaceuticals, Inc.

Registry information

Official study title

A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections

Important dates

Study start
2004
Study completion
2006
First posted
Sep 29, 2005
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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