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Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status and phase

Completed
Phase 3

Conditions

Bacterial Infections and Mycoses
Cholecystitis
Appendicitis
Peritonitis
Pancreatitis

Treatments

Drug: doripenem

Study type

Interventional

Funder types

Industry

Identifiers

NCT00229060
CR005389

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

483 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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