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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00360607

Collaborator

(none)

307

Enrollment

Locations

Duration (Months)

15.4

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	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.	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

307 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2004

Actual Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome 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 Outcome 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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Ahmedabad	Gujarat	India	380 009
2	Pfizer Investigational Site	Ahmedabad	Gujarat	India	380 052
3	Pfizer Investigational Site	Ahmedabad	Gujarat	India	380016
4	Pfizer Investigational Site	Bangalore	Karnataka	India	560 001
5	Pfizer Investigational Site	Kochi	Kerala	India	682 026
6	Pfizer Investigational Site	Kochi	Kerala	India	682304
7	Pfizer Investigational Site	Bhopal	Madhya Pradesh	India	462 038
8	Pfizer Investigational Site	Indore	Madhya Pradesh	India	452 014
9	Pfizer Investigational Site	Mumbai	Maharashtra	India	400 022
10	Pfizer Investigational Site	Pune	Maharashtra	India	411 001
11	Pfizer Investigational Site	Jaipur	Rajasthan	India	302015
12	Pfizer Investigational Site	Lucknow	Uttar Pradesh	India	226 014
13	Pfizer Investigational Site	Bangalore		India	560 054
14	Pfizer Investigational Site	Chandigarh		India	160 012
15	Pfizer Investigational Site	Coimbatore		India	641 014
16	Pfizer Investigational Site	Hyderabad		India	500 068
17	Pfizer Investigational Site	Hyderabad		India
18	Pfizer Investigational Site	Lucknow		India	226 003
19	Pfizer Investigational Site	Ludhiana		India	141 001
20	Pfizer Investigational Site	Mumbai		India	400 012