Infection
Conditions
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.
Interventions
DRUGMagnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.
DRUGFortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited
DRUGMetrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.
DRUGMikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Total duration of study treatment | — |
| The proportion of clinical efficacy | — |
| Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole. | — |
| 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, | — |
Countries
India
Outcome results
None listed