NCT01060891

Brief Summary

Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria

Trial Health

80
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

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

May 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

5.9 years

First QC Date

January 29, 2010

Last Update Submit

October 10, 2016

Conditions

Gram-negative Bacteria

Keywords

patients infected with with multiresistant gram-negative bacteria

Interventions

colimycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 85 years
  • Patients with nosocomial infection justifying Colistin.

You may not qualify if:

  • Known hypersensitivity to Colistin or products of the polymyxin family
  • Personal and family history for myasthenia
  • Positive serology for HBV, HCV and HIV
  • Positive pregnancy test or currently lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poitiers University Hospital - 2 rue de la Milétrie

Poitiers, 86021, France

Location

Related Publications (1)

  • Boisson M, Gregoire N, Cormier M, Gobin P, Marchand S, Couet W, Mimoz O. Pharmacokinetics of nebulized colistin methanesulfonate in critically ill patients. J Antimicrob Chemother. 2017 Sep 1;72(9):2607-2612. doi: 10.1093/jac/dkx167.

    PMID: 28575278DERIVED

MeSH Terms

Interventions

Colistin

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

May 1, 2009

Primary Completion

April 1, 2015

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

FR(1)