Clinical trial NCT00360607: A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-08-04
Enrollment: 307
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
measure: Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
measure: Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
measure: Physical examination findings.
Secondary outcomes:
measure: The proportion of clinical efficacy
measure: evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;
measure: proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome
measure: success or presumed success) at the end of study treatment,
measure: Total duration of study treatment
measure: Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Kochi
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Bhopal
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Indore
country: India
facility: Pfizer Investigational Site
state: Madhya Pradesh
city: Mumbai
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
city: Chandigarh
country: India
facility: Pfizer Investigational Site
city: Coimbatore
country: India
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
city: Lucknow
country: India
facility: Pfizer Investigational Site
city: Ludhiana
country: India
facility: Pfizer Investigational Site
city: Mumbai
country: India
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.