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

Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360607
• Other study ID #: A1891002
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2006
• Last updated: December 1, 2008
• Start date: July 2004
• Est. completion date: April 2005

Study information

• Verified date: December 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Intraabdominal Infections

Intervention

Drug:
• Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.

• Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited

• Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.

• Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Bangalore
India	Pfizer Investigational Site	Bhopal	Madhya Pradesh
India	Pfizer Investigational Site	Chandigarh
India	Pfizer Investigational Site	Coimbatore
India	Pfizer Investigational Site	Hyderabad
India	Pfizer Investigational Site	Hyderabad
India	Pfizer Investigational Site	Indore	Madhya Pradesh
India	Pfizer Investigational Site	Jaipur	Rajasthan
India	Pfizer Investigational Site	Kochi	Kerala
India	Pfizer Investigational Site	Kochi	Kerala
India	Pfizer Investigational Site	Lucknow
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Ludhiana
India	Pfizer Investigational Site	Mumbai
India	Pfizer Investigational Site	Mumbai	Maharashtra
India	Pfizer Investigational Site	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
Primary	Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
Primary	Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
Primary	Physical examination findings.
Secondary	The proportion of clinical efficacy
Secondary	evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;
Secondary	proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome
Secondary	success or presumed success) at the end of study treatment,
Secondary	Total duration of study treatment
Secondary	Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.

External Links

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