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Completed

NCT Number: NCT00360607

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

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Key information

Conditions

Infection Infections

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Ahmedabad, Gujarat, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.

  2. Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.

  3. Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.

  4. Physical examination findings.

Secondary outcomes

  1. The proportion of clinical efficacy

  2. evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;

  3. proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome

  4. success or presumed success) at the end of study treatment,

  5. Total duration of study treatment

  6. Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Aug 4, 2006
Registry last updated
Dec 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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