Abscess, Intra-Abdominal Clinical Trial
Official title:
Single Centre, Prospective, Comparative, Open-label, Randomised Study to Evaluate the Efficacy and Tolerability of the Combination of Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
The study is contemplating the antibiotic therapy of intraabdominal abscesses. These
abscesses are a serious problem in surgical practice. Associated pathophysiologic effects as
for example peritonitis may become life threatening or may lead to extended periods of
morbidity with prolonged hospitalization.
The objective of the sudy is to evaluate whether the combination of Moxifloxacin and
Metronidazole is equivalent to Piperacillin / Tazobactam with regard to clinical outcome and
eradication of aerobe and anaerobe pathogens in patients with intra-abdominal abscesses.
The study is an interventional prospective, comparative, open-label, randomised single-centre
study. Adult patients with intra-abdominal abscesses matching the criteria to be included
will be enrolled in the study and randomised into one of the Groups: 1. Moxifloxacin 400 mg,
administered intravenously once daily in combination with Metronidazole 500 mg, administered
two times daily intravenously, followed by an oral medication with Moxifloxacin 400 mg once
daily and Metronidazole 500 mg twice daily. 2. Piperacillin / Tazobactam 4,5 g administered
intravenously three times daily.
Primary study endpoints: Clinical success / failure rate at the Test-of-Cure visit.
Secondary study endpoints: -Bacteriological response at TOC, -Clinical + Bacteriological
response at End-of-Treatment-visit, - Course of disease on the basis of clinical and
laboratory parameters, -Time to discharge from hospitals, -Duration of hospitalization
post-operatively, - safety and tolerability of the study medication, -cost effectiveness of
treatment regimes.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT00463762 -
Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections.
|
Phase 4 | |
| Terminated |
NCT01110382 -
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
|
Phase 3 | |
| Completed |
NCT01096511 -
Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)
|
N/A |