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Doripenem in the Treatment of Complicated Intra-Abdominal Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00210938
First Posted: September 21, 2005
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Peninsula Pharmaceuticals, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  Purpose
The purpose of this study is to compare the clinical response rates of doripenem versus a comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal infections.

Condition Intervention Phase
Bacterial Infections and Mycoses Appendicitis Cholecystitis Pancreatitis Peritonitis Drug: Doripenem Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Phase 3 Study of Doripenem Versus Comparator Antibiotic in the Treatment of Complicated Intra-Abdominal Infections

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Clinical response rate measured at late follow-up visit.

Secondary Outcome Measures:
  • Clinical response rate measured at early follow-up visit. Microbiological response rate at both early and late follow-up visits. Safety assessment (adverse events, changes in vital signs, laboratory tests results) conducted throughout the study.

Enrollment: 478
Study Start Date: March 2004
Study Completion Date: January 2006
Detailed Description:
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, double-blind study of intravenous doripenem versus a comparator antibiotic to assess the effectiveness and safety of doripenem in the treatment of complicated intra-abdominal infections in hospitalized adults. The primary endpoint is the clinical response rate measured at late follow-up visit. The patients will receive either doripenem or comparator; treatment duration is 5 to 14 days.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00210938


Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00210938     History of Changes
Other Study ID Numbers: CR005383
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 10, 2011
Last Verified: April 2010

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Complicated Intra-Abdominal Infections
Appendicitis
Cholecystitis
Peritonitis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Pancreatitis
Mycoses
Bacterial Infections
Appendicitis
Peritonitis
Intraabdominal Infections
Cholecystitis
Acalculous Cholecystitis
Pancreatic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Cecal Diseases
Intestinal Diseases
Peritoneal Diseases
Gallbladder Diseases
Biliary Tract Diseases