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

Primary Purpose

Colistin, Rifampin, Acinetobacter Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
colistin and rifampin combination therapy
colistin monotherapy
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colistin

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    colistin monotherapy

    colistin-rifampin combination

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    microbiologic response
    negative conversion of culture study (eradication)

    Secondary Outcome Measures

    clinical response
    clinical resolution of fever, symptoms and infectious sign
    mortality
    mortality

    Full Information

    First Posted
    July 30, 2018
    Last Updated
    August 6, 2018
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03622918
    Brief Title
    Colistin-rifampin Combination and Colistin Monotherapy in Extensively Drug-resistant Acinetobacter Baumannii
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 27, 2016 (Actual)
    Primary Completion Date
    September 24, 2017 (Actual)
    Study Completion Date
    June 21, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colistin, Rifampin, Acinetobacter Infections

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    colistin monotherapy
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    colistin-rifampin combination
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    colistin and rifampin combination therapy
    Other Intervention Name(s)
    colistin/rifampin combination therapy
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    colistin monotherapy
    Intervention Description
    . 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 .
    Primary Outcome Measure Information:
    Title
    microbiologic response
    Description
    negative conversion of culture study (eradication)
    Time Frame
    14 days
    Secondary Outcome Measure Information:
    Title
    clinical response
    Description
    clinical resolution of fever, symptoms and infectious sign
    Time Frame
    14 days
    Title
    mortality
    Description
    mortality
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    in discuss
    Citations:
    PubMed Identifier
    30476654
    Citation
    Park HJ, Cho JH, Kim HJ, Han SH, Jeong SH, Byun MK. Colistin monotherapy versus colistin/rifampicin combination therapy in pneumonia caused by colistin-resistant Acinetobacter baumannii: A randomised controlled trial. J Glob Antimicrob Resist. 2019 Jun;17:66-71. doi: 10.1016/j.jgar.2018.11.016. Epub 2018 Nov 23.
    Results Reference
    derived

    Learn more about this trial

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

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