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

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 009 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00360607
Pfizer
Completed
A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections

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A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Not Provided
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.
 
Completed
307
April 2005
Not Provided

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)
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00360607
A1891002
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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