MULTICENTRIC, RANDOMIZED, DOUBLE-BLIND STUDY TO COMPARE THE SAFETY AND EFFICACY OF THE ADMINISTRATION OF TIGECICLINE WITH IMIPENEM / CILASTATIN IN THE TREATMENT OF COMPLICATED INTRABDOMINAL INFECTIONS OF INTERNAL PATIENTS

Phase 1

• Conditions: -K678 Other disorders of peritoneum in infectious diseases classified elsewhere; Other disorders of peritoneum in infectious diseases classified elsewhere; K678

• Registration Number: PER-005-03
• Lead Sponsor: ABORATORIOS WYETH S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-02-19
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Men or women interned,> 18 years of age.
The subject of having undergone, or should have planned, a laparotomy, a
laparoscopy or a percutaneous drainage of an intra-abdominal abscess.
Subjects with a complicated intra-abdominal infection
The subject received no more than one dose of the parenteral antibiotic

Exclusion Criteria

An active or treated leukemia, or a malignant systemic disease that required chemotherapy, immunotherapy, radiotherapy or antineoplastic therapy during the previous year.
Early discharge that shortened the intemacion to a lapse of less than 5 days.
The presence of any uncontrolled disease of the nervous system
central.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Aerobic and anaerobic crops.<br>Measure:The safety and efficacy of tigecycline, with the combination of imipenem / cilastatin, in the treatment of complicated intra-abdominal infections of inpatients.<br>Timepoints:week 5 ± 1 week after the administration of the first dose of the study drug.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Aerobic and anaerobic crops.<br>Measure:In vitro sensitivity to tigecycline for a spectrum of pathogenic bacteria that cause complicated intra-abdominal infections.<br>Timepoints:week 5 ± 1 week after the administration of the first dose of the study drug.<br>