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