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

Study Overview
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Brief Summary
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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
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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

Conditions
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Infection

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |