NCT03622918

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
Last Updated

August 9, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

July 30, 2018

Last Update Submit

August 6, 2018

Conditions

ColistinRifampinAcinetobacter Infections

Outcome Measures

Primary Outcomes (1)

  • microbiologic response

    negative conversion of culture study (eradication)

    14 days

Secondary Outcomes (2)

  • clinical response

    14 days

  • mortality

    30 days

Study Arms (2)

colistin monotherapy

SHAM COMPARATOR

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.

Drug: colistin monotherapy

colistin-rifampin combination

EXPERIMENTAL

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.

Drug: colistin and rifampin combination therapy

Interventions

colistin and rifampin combination therapyDRUG

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.

Also known as: colistin/rifampin combination therapy
colistin-rifampin combination
colistin monotherapyDRUG

. 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 .

colistin monotherapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pneumonia, blood septicemia, urinary tract infection, or other infection or even colonization with evidence of extensively drug-resistant Acinetobacter baumannii infection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30476654DERIVED

MeSH Terms

Conditions

Acinetobacter Infections

Interventions

Colistin

Condition Hierarchy (Ancestors)

Moraxellaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 9, 2018

Study Start

October 27, 2016

Primary Completion

September 24, 2017

Study Completion

June 21, 2018

Last Updated

August 9, 2018

Record last verified: 2018-08