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
1 other identifier
interventional
307
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2004
Shorter than P25 for phase_4
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 3, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedDecember 2, 2008
December 1, 2008
August 3, 2006
December 1, 2008
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (20)
Pfizer Investigational Site
Ahmedabad, Gujarat, 380 009, India
Pfizer Investigational Site
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
Related Publications (1)
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.
PMID: 18570578DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 3, 2006
First Posted
August 4, 2006
Study Start
July 1, 2004
Study Completion
April 1, 2005
Last Updated
December 2, 2008
Record last verified: 2008-12