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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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-005-03
Enrollment
Unknown
Registered
2003-02-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intravenous tigecycline will be given Group name:imipenem / cilastatin Type of group
Intravenous imipenem / cilastatin will be administered.

Sponsors

LABORATORIOS WYETH S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

Argentina, Brazil, Canada, Chile, Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)