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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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; | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Ahmedabad | Gujarat | 380 009 | India | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18570578 | Derived | Chandra A, Dhar P, Dharap S, Goel A, Gupta R, Hardikar JV, Kapoor VK, Mathur AK, Modi P, Narwaria M, Ramesh MK, Ramesh H, Sastry RA, Shah S, Virk S, Sudheer OV, Sreevathsa MR, Varshney S, Kochhar P, Somasundaram S, Desai C, Schou M. Cefoperazone-sulbactam for treatment of intra-abdominal infections: results from a randomized, parallel group study in India. Surg Infect (Larchmt). 2008 Jun;9(3):367-76. doi: 10.1089/sur.2007.013. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| 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. |
| Ahmedabad |
| Gujarat |
| 380 052 |
| India |
| Pfizer Investigational Site | Ahmedabad | Gujarat | 380016 | India |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 001 | India |
| Pfizer Investigational Site | Kochi | Kerala | 682 026 | India |
| Pfizer Investigational Site | Kochi | Kerala | 682304 | India |
| Pfizer Investigational Site | Bhopal | Madhya Pradesh | 462 038 | India |
| Pfizer Investigational Site | Indore | Madhya Pradesh | 452 014 | India |
| Pfizer Investigational Site | Mumbai | Maharashtra | 400 022 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 001 | India |
| Pfizer Investigational Site | Jaipur | Rajasthan | 302015 | India |
| Pfizer Investigational Site | Lucknow | Uttar Pradesh | 226 014 | India |
| Pfizer Investigational Site | Bangalore | 560 054 | India |
| Pfizer Investigational Site | Chandigarh | 160 012 | India |
| Pfizer Investigational Site | Coimbatore | 641 014 | India |
| Pfizer Investigational Site | Hyderabad | 500 068 | India |
| Pfizer Investigational Site | Hyderabad | India |
| Pfizer Investigational Site | Lucknow | 226 003 | India |
| Pfizer Investigational Site | Ludhiana | 141 001 | India |
| Pfizer Investigational Site | Mumbai | 400 012 | India |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013407 | Sulbactam |
| D002438 | Cefoperazone |
| D002442 | Ceftazidime |
| D008795 | Metronidazole |
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002435 | Cefamandole |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D002509 | Cephaloridine |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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