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

Acinetobacter Infections Clinical Trial

Official title:

Comparison of Efficacy and Safety of Colistin-rifampin Combination and Colistin Monotherapy in Extensively Drug-resistant Acinetobacter Baumannii: Utility of the Synergy Test Results (E-test) in Vitro

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622918
• Other study ID #: 3-2016-0125
• Status: Completed
• Phase: N/A
• Start date: October 27, 2016
• Est. completion date: June 21, 2018

Study information

• Verified date: August 2018
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 21, 2018
• Est. primary completion date: September 24, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acinetobacter Infections
• Colistin
• Rifampin

Intervention

Drug:
• 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 (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 .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbiologic response	negative conversion of culture study (eradication)	14 days
Secondary	clinical response	clinical resolution of fever, symptoms and infectious sign	14 days
Secondary	mortality	mortality	30 days