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”

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

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

Intervention(s) in this Clinical Trial

• 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.

Primary 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 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.

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00360607

Study ID Number: A1891002

ClinicalTrials.gov Identifier: NCT00360607

Health Authority: India: Institutional Review Board

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