A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections
NCT00360607
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- 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
- 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)
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Descriptive Information | ||||
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Brief Title ICMJE | A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Infection | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 307 | |||
Original Enrollment ICMJE | 300 | |||
Actual Study Completion Date ICMJE | April 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | India | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00360607 | |||
Other Study ID Numbers ICMJE | A1891002 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | December 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |