Doripenem in the Treatment of Complicated Intra-Abdominal Infections

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00229060
Study type	Interventional
Source	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status	Completed
Phase	Phase 3
Start date	March 2004
Completion date	March 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04529980` - Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis	N/A
Withdrawn	`NCT03528343` - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy	Phase 1/Phase 2
Recruiting	`NCT03522233` - Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
Recruiting	`NCT03380793` - A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis	Phase 4
Recruiting	`NCT02108340` - Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis	N/A
Terminated	`NCT02029781` - The Laparoscopic Appendicitis Score; a Multicenter Validation Study	N/A
Completed	`NCT01356641` - Antibiotic Treatment Alone for Acute Simple Appendicitis in Children	N/A
Completed	`NCT01515293` - Single Incision Versus Conventional Laparoscopic Appendectomy	Phase 3
Terminated	`NCT00971438` - Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging	N/A
Completed	`NCT00913380` - Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT	Phase 3
Completed	`NCT00616616` - Single Incision Laparoscopy	N/A
Completed	`NCT00530998` - Minimally Invasive Surgery: Using Natural Orfices
Completed	`NCT00195351` - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection	Phase 4
Completed	`NCT02916134` - Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis	N/A
Completed	`NCT04614649` - Right Iliac Fossa Treatment-Turkey Audit
Completed	`NCT04365491` - European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
Completed	`NCT03770897` - Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome	N/A
Completed	`NCT02507674` - Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
Active, not recruiting	`NCT01718275` - Non-operative Management of Early Appendicitis in Children
Terminated	`NCT01575028` - Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies	Phase 2