Drug Safety
Conditions
Keywords
A. baumannii, colistin, fosfomycin
Brief summary
In Siriraj Hospital, colistin alone for treatment of MDR A. baumannii contributed to mortality 45% Fosfomycin is an antimicrobial which has activity against gram-negative bacterial including MDR A. baumannii In this study, we compare the clinical and microbiologicalresponse of colistin alone versus colistin plus fosfomycin in treatment of A. baumannii infected patients
Detailed description
Inclusion criteria * Age\> 18 years * Hospitalized to Siriraj Hospital * Infected caused by A. baumannii * Need Colistin treatment Exclusion criteria * Pregnancy or Lactating mother * Colistin or Fosfomycin Allergy * Patients who have severe abnormal renal or liver function
Interventions
DRUGcolistin
Colistimethate sodium 2.5-5mg/kg of colistin base
DRUGcolistin plus fosfomycin
colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\> 18 years * Hospitalized to Siriraj Hospital * Infected caused by A. baumannii * Need Colistin treatment
Exclusion criteria
* Pregnancy or Lactating mother * Colistin or Fosfomycin Allergy * Patients who have severe abnormal renal or liver function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of subjects with cure or improvement | up to 28days | cure improvement worse death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of subjects with eradication of causative bacteria | up to 28days | eradication persistence superinfection |
Countries
Thailand
Contacts
Primary ContactDr Visanu Thamlikitkul, Professor
Backup ContactDr Pornpan Koomanachai, MD
Outcome results
None listed