A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00360607
First received: August 3, 2006
Last updated: December 1, 2008
Last verified: December 2008
  Purpose

Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside and metronidazole are often used to treat such infections in surgical settings. An alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections. The combination of ceftazidime, amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of Gram-negative and anaerobic organisms found in such conditions.


Condition Intervention Phase
Infection
Drug: Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.
Drug: Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited
Drug: Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.
Drug: Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Multicentre Phase Iv Study To Evaluate The Efficacy And Safety Of Magnex (Cefoperazone-Sulbactam) In Comparison With Ceftazidime Plus Amikacin And Metronidazole In The Treatment Of Intra-Abdominal Infections

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
  • Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
  • Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
  • Physical examination findings.

Secondary Outcome Measures:
  • The proportion of clinical efficacy
  • evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;
  • proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome
  • success or presumed success) at the end of study treatment,
  • Total duration of study treatment
  • Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.

Enrollment: 307
Study Start Date: July 2004
Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects aged greater or equal to 12 years
  • Intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening
  • Presence of at least three of the following five indicators consistent with intra-abdominal infections (Fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation)
  • Written informed consent obtained

Exclusion Criteria:

  • Rapidly progressive illness or critically ill subjects
  • Pregnant or lactating women, or women of childbearing potential not using an effective method of contraception.
  • Treatment with a presumably effective systemic antimicrobial agent for >24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360607

Locations
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380016
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 052
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 009
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 001
Pfizer Investigational Site
Kochi, Kerala, India, 682304
Pfizer Investigational Site
Kochi, Kerala, India, 682 026
Pfizer Investigational Site
Bhopal, Madhya Pradesh, India, 462 038
Pfizer Investigational Site
Indore, Madhya Pradesh, India, 452 014
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 022
Pfizer Investigational Site
Pune, Maharashtra, India, 411 001
Pfizer Investigational Site
Jaipur, Rajasthan, India, 302015
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226 014
Pfizer Investigational Site
Bangalore, India, 560 054
Pfizer Investigational Site
Chandigarh, India, 160 012
Pfizer Investigational Site
Coimbatore, India, 641 014
Pfizer Investigational Site
Hyderabad, India
Pfizer Investigational Site
Hyderabad, India, 500 068
Pfizer Investigational Site
Lucknow, India, 226 003
Pfizer Investigational Site
Ludhiana, India, 141 001
Pfizer Investigational Site
Mumbai, India, 400 012
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00360607     History of Changes
Other Study ID Numbers: A1891002
Study First Received: August 3, 2006
Last Updated: December 1, 2008
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Intraabdominal Infections
Infection
Amikacin
Cefoperazone
Ceftazidime
Sulbactam
Sulperazone
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014