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Last Updated: June 30, 2022

CLINICAL TRIALS PROFILE FOR COLISTIMETHATE SODIUM


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All Clinical Trials for Colistimethate Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01025921 ↗ Tracheobronchitis Prevention Trial Completed University of Thessaly N/A 2009-11-01 We aim to study whether the use of inhaled antibiotics may have an impact on the incidence of tracheobronchitis and pneumonia associated with the use of mechanical ventilation. The investigators hypothesize that this could be possible by decreasing the population of gram negative germs that colonize the lumen of tracheal tube and upper airways.
NCT01400750 ↗ Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis Completed Universitaire Ziekenhuizen Leuven Phase 4 2001-08-01 Treatment of new Pseudomonas aeruginosa (Pa) infection in cystic fibrosis (CF) can postpone chronic infection. Aim of the study: compare 2 Pa eradication regimens in children with new Pa infection.
NCT01449838 ↗ Phase I Study of Colistin Methanesulfonate Sodium Completed GlaxoSmithKline Phase 1 2010-10-23 This is a clinical study protocol for a single centre, randomized, double blind, placebo controlled, single and repeat dose study to investigate the safety, tolerability and pharmacokinetics of intravenous dosing of Colistin Methanesulfonate Sodium (CMS-Na) in healthy Japanese male subjects. Eighteen subjects will receive CMS-Na 2.5mg/kg (as colistin activity or 75,000 IU/kg) or placebo as a single dose and twice daily for 2.5 days by intravenous infusion. Blood and urine samples for pharmacokinetics analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of vital signs, Echocardiogram (ECGs), safety laboratory data, renal function and review of adverse events.
NCT01597973 ↗ Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli Completed Kaye, Keith, M.D., M.P.H. Phase 3 2012-10-06 Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both BSI and pneumonia at the time of study enrollment, they will be included as a subject with pneumonia. Objectives: Primary: •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to XDR-GNB. Secondary: •Determine what treatment regimen (colistin monotherapy or colistin combined with a carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy.
NCT01597973 ↗ Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli Completed University of Michigan Phase 3 2012-10-06 Approximately 444 subjects who are greater than or equal to 18 to 95 years of age, are non-pregnant, and are in the inpatient setting of one of the study sites will be evaluated to treatment efficacy. Analysis will include subjects with bloodstream infection (BSI) or pneumonia due to at least one of the following gram-negative bacilli organisms: Acinetobacter baumannii, Klebsiella spp, Escherichia coli, Enterbactor spp. and/or Pseudomonas aeruginosa that demonstrates in vitro non-susceptibility defined as extensively drug-resistant Gram-negative bacilli (XDR-GNB) which includes XDR-AB, XDR-PA and CRE. If a subject has both BSI and pneumonia at the time of study enrollment, they will be included as a subject with pneumonia. Objectives: Primary: •Determine whether the treatment regimen of Colistimethate sodium (colistin) combined with a carbapenem (imipenem or meropenem) is associated with a decreased risk for mortality compared to colistin alone for subjects with bloodstream infection (BSI) and/or pneumonia due to XDR-GNB. Secondary: •Determine what treatment regimen (colistin monotherapy or colistin combined with a carbapenem (imipenem or meropenem) is more likely to reduce the emergence of colistin resistance among XDR-GNB isolates during therapy.
NCT01732250 ↗ Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem Completed European Commission Phase 4 2013-03-01 The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria
NCT01732250 ↗ Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem Completed Mical Paul Phase 4 2013-03-01 The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Colistimethate Sodium

Condition Name

Condition Name for Colistimethate Sodium
Intervention Trials
Pneumonia 3
Colistin 2
Colistin Adverse Reaction 2
Non Cystic Fibrosis Bronchiectasis 2
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Condition MeSH

Condition MeSH for Colistimethate Sodium
Intervention Trials
Pneumonia 7
Communicable Diseases 5
Infections 5
Infection 5
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Clinical Trial Locations for Colistimethate Sodium

Trials by Country

Trials by Country for Colistimethate Sodium
Location Trials
United States 28
Greece 9
Italy 6
Israel 6
Australia 3
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Trials by US State

Trials by US State for Colistimethate Sodium
Location Trials
California 3
Ohio 2
New York 2
Michigan 2
Florida 2
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Clinical Trial Progress for Colistimethate Sodium

Clinical Trial Phase

Clinical Trial Phase for Colistimethate Sodium
Clinical Trial Phase Trials
Phase 4 5
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Colistimethate Sodium
Clinical Trial Phase Trials
Completed 12
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Colistimethate Sodium

Sponsor Name

Sponsor Name for Colistimethate Sodium
Sponsor Trials
Zambon SpA 2
University of Thessaly 2
Merck Sharp & Dohme Corp. 1
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Sponsor Type

Sponsor Type for Colistimethate Sodium
Sponsor Trials
Other 16
Industry 7
NIH 1
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