Acinetobacter Infections, Colistin, Rifampin
Conditions
Brief summary
The investigators aimed to confirm the utility of the synergy test results (E-tesT) in vitro to predict the efficacy and safety of colistin-rifampin combination and colistin monotherapy in extensively drug-resistant acinetobacter baumannii.
Detailed description
We will searched pneumonia patients with CoRAB in Gangnam Severance Hospital. Subjects will be enrolled and randomized in a blinded fashion using a computerized random number generator (permuted-block randomization) for treatment with colistin and rifampin combination and colistin only at a ratio of 1:1. We will perform the E-test MIC:MIC ratio method to predict in vitro synergy of colistin and rifampin combination therapy.
Interventions
DRUGcolistin and rifampin combination therapy
Colistin (100 mg, colistin sodium methanesulfonate, SCD Pharm., Seoul, Korea) will be intravenously administered with 100 mL of normal saline with 8 hours interval. Rifampin (600 mg, rifampin, Yuhan, Seoul, Korea) will be orally administered daily. Treatment should be maintained daily administration for at least 7 days and up to 28 days. Duration of antibiotics treatment will be determined through discussion by pulmonology and infection specialist.
DRUGcolistin monotherapy
. Colistin (100 mg, colistin sodium methanesulfonate, SCD Pharm., Seoul, Korea) will be intravenously administered with 100 mL of normal saline with 8 hours interval. Treatment should be maintained daily administration for at least 7 days and up to 28 days. Duration of antibiotics treatment wil be determined through discussion by pulmonology and infection specialist .
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pneumonia, blood septicemia, urinary tract infection, or other infection or even colonization with evidence of extensively drug-resistant Acinetobacter baumannii infection
Exclusion criteria
* Hypersensitivity reaction to colistin or rifampin * use of colistin or rifampin in 15 days prior to screening * evidence of extensively drug-resistant Acinetobacter baumannii infection in 15 days prior to screening * CLcr \< 15 mL/min, ALT or AST \> 3xULN, total bilirubin \> 2xULN, Hb \< 7 gm/dL, ANC \< 500/mm3, Platelet \< 50,000/mm3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| microbiologic response | 14 days | negative conversion of culture study (eradication) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical response | 14 days | clinical resolution of fever, symptoms and infectious sign |
| mortality | 30 days | mortality |
Outcome results
None listed