Colistin-rifampin Combination and Colistin Monotherapy in Extensively Drug-resistant Acinetobacter Baumannii

Not Applicable

Completed

• Conditions: Rifampin; Acinetobacter Infections; Colistin
• Interventions: Drug: colistin and rifampin combination therapy; Drug: colistin monotherapy

• Registration Number: NCT03622918
• Lead Sponsor: Gangnam Severance Hospital

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.

Study Timeline

• Study Start: 2016-10-27
• Primary Completion: 2017-09-24
• Study Completion: 2018-06-21
• Study First Submitted: 2018-07-30
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-06
• Last Update Submitted: 2018-08-06
• Study First Posted: 2018-08-09
• Last Update Posted: 2018-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
colistin-rifampin combination	colistin and rifampin combination therapy	The subjects will be treated with colistin 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.
colistin monotherapy	colistin monotherapy	The subjects will be treated with colistin 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 will be determined through discussion by pulmonology and infection specialist.

Primary Outcome Measures

Name	Time	Method
microbiologic response	14 days	negative conversion of culture study (eradication)

Secondary Outcome Measures

Name	Time	Method
clinical response	14 days	clinical resolution of fever, symptoms and infectious sign
mortality	30 days	mortality