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

Pfizer307 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

307

Conditions

Infection

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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)

Locations (20)

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

Kochi, Kerala, India

Pfizer Investigational Site

Kochi, Kerala, India

Pfizer Investigational Site

Bhopal, Madhya Pradesh, India

Pfizer Investigational Site

Indore, Madhya Pradesh, India

Pfizer Investigational Site

Mumbai, Maharashtra, India

Pfizer Investigational Site

Pune, Maharashtra, India

...and 10 more locations

Outcomes

Primary Outcomes

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 Outcomes

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.