Eficacia y seguridad del tratamiento de infecciones nosocomiales graves causadas por Acinetobacter baumannii multirresistente con rifampicina más imipenem.Efficacy and safety to the treatment of severe nosocomial infections caused by multiresistant Acinetobacter baumannii with rifampin plus imipenem.

• Conditions: eumonía, bacteriemia e infección complicada de piel y partes blandas causadas por Acinetobacter baumannii.Pneumonia, bacteremia and complicated skin and soft-tissue infections caused by Acinetobacter baumannii.; MedDRA version: 9.1Level: LLTClassification code 10035664Term: Pneumonia; MedDRA version: 9.1Level: LLTClassification code 10003999Term: Bacteremia; MedDRA version: 9.1Level: HLTClassification code 10040788Term: Skin and subcutaneous tissue bacterial infections

• Registration Number: EUCTR2007-005268-29-ES
• Lead Sponsor: niversity Hospital Virgen del Rocío, Andalousian Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

* Patient must be iqual or older than 18 years.
* Patient must have 60 kilograms of weight or higher.
* Hospital stay more than 72 hours.
* Female patient of child bearing potential must have a negative serum pregnacy test prior to enrollment and must agree to practice effective birth control during the study.
* Acinetobacter baumannii infection with any of the following diagnosis:
- bacteremia
- nosocomial pneumonia
- complicated skin and soft-tissue infection
* MIC (minimun inhibitory concentration) of imipenem < or equal to 32 mg/L and MIC of rifampicin < or equal to 4 mg/L (E- test).
* Patient or legal representative must sign an informed consent form, approved by the Ethics Committee.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

* Refractary shock or another illness that, in investigator opinion, the patient life expectancy is less than 48 hours.
* Patient with non-resucitation order.
* Infect¡ous endocarditis, osteomyelitis, or meningitis, suspected or confirmed.
* Hypersensitivity to betalactams or rifampicin, prior to study.
* Prior chronic liver disease or alcoholism.
* Acute hepatitis or simultaneous hepatotoxic drugs administration.
* Patient has been treated with non-authorized drugs during the last 30 days.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified