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

Condition(s) targeted: Infection

Intervention: 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. (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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)

Pfizer Investigational Site, Mumbai 400 012, India

Pfizer Investigational Site, Chandigarh 160 012, India

Pfizer Investigational Site, Ludhiana 141 001, India

Pfizer Investigational Site, Coimbatore 641 014, India

Pfizer Investigational Site, Lucknow 226 003, India

Pfizer Investigational Site, Bangalore 560 054, India

Pfizer Investigational Site, Hyderabad 500 068, India

Pfizer Investigational Site, Hyderabad, India

Pfizer Investigational Site, Ahmedabad, Gujarat 380016, India

Pfizer Investigational Site, Ahmedabad, Gujarat 380 052, India

Pfizer Investigational Site, Ahmedabad, Gujarat 380 009, India

Pfizer Investigational Site, Bangalore, Karnataka 560 001, India

Pfizer Investigational Site, Kochi, Kerala 682 026, India

Pfizer Investigational Site, Kochi, Kerala 682304, India

Pfizer Investigational Site, Indore, Madhya Pradesh 452 014, India

Pfizer Investigational Site, Bhopal, Madhya Pradesh 462 038, India

Pfizer Investigational Site, Pune, Maharashtra 411 001, India

Pfizer Investigational Site, Mumbai, Maharashtra 400 022, India

Pfizer Investigational Site, Jaipur, Rajasthan 302015, India

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226 014, India

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: July 2004
Last updated: March 11, 2008