Severe nosocomial infections due to multi-drug resistant Acinetobacter baumannii MedDRA version: 9.1 Level: SOC Classification code 10021881
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Rifampicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Sponsors
AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Microbiological evidence of severe infection due to multi-drug resistant A. baumannii during hospitalization, with susceptibility of the isolate to colistin (MIC 2 mg/l), irrespective of the susceptibility to rifampicin. 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
Exclusion criteria: Exclusion criteria will be as follows: age below 18 years; treatment with one of the study drugs prior to the diagnosis of A. baumannii infection; severe liver dysfunction; history of prior hypersensitivity to the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy and safety of the combination treatment with colistin and rifampicin versus colistin alone in severe infections due to multi-drug resistant Acinetobacter baumannii.;Secondary Objective: 1. to establish whether the combination of colistin and rifampicin reduces the disease-specific lethality rate; 2. to assess the efficacy of the combination therapy on microbiological eradication rate; 3. to establish if hospitalization length and, thus, costs for the health service are substantially reduced by the combination treatment; 4. to analyse whether the rate of emergence of resistance to colistin is reduced by the concurrent use of rifampicin;Primary end point(s): The study primary objective is to assess whether the association of colistin and rifampicin reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with the current treatment with colistin alone. | — |
Countries
Italy
Outcome results
None listed