Neumonía, 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: 9.1 Level: LLT Classification code 10035664 Term: Pneumonia MedDRA version: 9.1 Level: LLT Classification code 10003999 Term: Bacteremia MedDRA version: 9.1 Level: HLT Classification code 10040788 Term: Skin and subcutaneous tissue bacterial infections
Conditions
Interventions
Trade Name: TIENAM
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: IMIPENEM
CAS Number: 64221869
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentratio
Sponsors
University Hospital Virgen del Rocío, Andalousian Health Service
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy of the treatment;Secondary Objective: Safety of the treatmant;Primary end point(s): Clinical response at the end of the treatment. | — |
Countries
Spain
Outcome results
None listed