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Generated: February 19, 2019

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CLINICAL TRIALS PROFILE FOR COLISTIMETHATE SODIUM

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Clinical Trials for Colistimethate Sodium

Trial ID Title Status Sponsor Phase Summary
NCT01025921 Tracheobronchitis Prevention Trial Completed University of Thessaly N/A 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 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.
NCT01597973 Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli Recruiting Kaye, Keith, M.D., M.P.H. Phase 3 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 Recruiting European Commission Phase 4 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 Recruiting Mical Paul Phase 4 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
NCT01863719 Aerosolized and Intravenous Colistin in Healthy Adults Recruiting National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 Colistin is amphipathic, cannot be absorbed from the gastrointestinal tract and is administered intramuscularly, intravenously (IV) or via inhalation. In the case of pneumonia, aerosolized route of administration is favorable as it presumably delivers a high concentration of drug directly to the infection site. Colistimethate sodium is an FDA approved drug, however, its aerosolized use represents a new method of administration not currently FDA-approved in the United States. In this proposal, the inactive prodrug colistimethate sodium has been selected to use for aerosolization as it is better tolerated than colistin sulphate. It is a randomized, open-labeled Phase 1 trial of aerosolized and/or IV formulations of colistin as multiple doses over seven days. The primary objective of this trial is to evaluate the safety and tolerability of multiple doses of aerosolized and intravenous colistimethate sodium separately or in combination in healthy adult subjects.
NCT01940731 Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults Unknown status Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd Phase 2 1. To evaluate the clinical and microbiological efficacy and safety of Colistimethate sodium Injection Vial to treat adults with hospital-acquired pneumonia . 2. To Learn the pharmacokinetic characteristics of continuous intravenous infusion of Colistimethate sodium.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Colistimethate Sodium

Condition Name

Condition Name for Colistimethate Sodium
Intervention Trials
Pneumonia 3
Non Cystic Fibrosis Bronchiectasis 2
Blood Stream Infection 1
Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE 1
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Condition MeSH

Condition MeSH for Colistimethate Sodium
Intervention Trials
Pneumonia 6
Communicable Diseases 4
Infection 4
Bacterial Infections 3
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Clinical Trial Locations for Colistimethate Sodium

Trials by Country

Trials by Country for Colistimethate Sodium
Location Trials
United States 9
Greece 3
Thailand 2
Italy 2
Chile 2
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Trials by US State

Trials by US State for Colistimethate Sodium
Location Trials
Ohio 2
California 2
New York 1
Michigan 1
Florida 1
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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 4
Phase 3 6
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Colistimethate Sodium
Clinical Trial Phase Trials
Recruiting 8
Completed 3
Not yet recruiting 2
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Clinical Trial Sponsors for Colistimethate Sodium

Sponsor Name

Sponsor Name for Colistimethate Sodium
Sponsor Trials
Zambon SpA 2
Department of Health and Human Services 1
DongGuk University 1
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Sponsor Type

Sponsor Type for Colistimethate Sodium
Sponsor Trials
Other 12
Industry 5
U.S. Fed 1
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