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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00360607 |
Purpose
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 | Intervention | 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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Enrollment: | 307 |
| Study Start Date: | July 2004 |
| Study Completion Date: | April 2005 |
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| India | |
| Pfizer Investigational Site | |
| Mumbai, India, 400 012 | |
| Pfizer Investigational Site | |
| Chandigarh, India, 160 012 | |
| Pfizer Investigational Site | |
| Ludhiana, India, 141 001 | |
| Pfizer Investigational Site | |
| Coimbatore, India, 641 014 | |
| Pfizer Investigational Site | |
| Lucknow, India, 226 003 | |
| Pfizer Investigational Site | |
| Bangalore, India, 560 054 | |
| Pfizer Investigational Site | |
| Hyderabad, India, 500 068 | |
| Pfizer Investigational Site | |
| Hyderabad, India | |
| India, Gujarat | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380016 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 052 | |
| Pfizer Investigational Site | |
| Ahmedabad, Gujarat, India, 380 009 | |
| India, Karnataka | |
| Pfizer Investigational Site | |
| Bangalore, Karnataka, India, 560 001 | |
| India, Kerala | |
| Pfizer Investigational Site | |
| Kochi, Kerala, India, 682 026 | |
| Pfizer Investigational Site | |
| Kochi, Kerala, India, 682304 | |
| India, Madhya Pradesh | |
| Pfizer Investigational Site | |
| Indore, Madhya Pradesh, India, 452 014 | |
| Pfizer Investigational Site | |
| Bhopal, Madhya Pradesh, India, 462 038 | |
| India, Maharashtra | |
| Pfizer Investigational Site | |
| Pune, Maharashtra, India, 411 001 | |
| Pfizer Investigational Site | |
| Mumbai, Maharashtra, India, 400 022 | |
| India, Rajasthan | |
| Pfizer Investigational Site | |
| Jaipur, Rajasthan, India, 302015 | |
| India, Uttar Pradesh | |
| Pfizer Investigational Site | |
| Lucknow, Uttar Pradesh, India, 226 014 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| Study ID Numbers: | A1891002 |
| Study First Received: | August 3, 2006 |
| Last Updated: | December 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00360607 History of Changes |
| Health Authority: | India: Institutional Review Board |
|
Communicable Diseases Metronidazole Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Amikacin Cefoperazone Physiological Effects of Drugs Enzyme Inhibitors |
Infection Pharmacologic Actions Sulbactam Ceftazidime Anti-Bacterial Agents Antiparasitic Agents Radiation-Sensitizing Agents Therapeutic Uses |