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Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01060891
First Posted: February 2, 2010
Last Update Posted: October 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Poitiers University Hospital
  Purpose
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

Condition Intervention Phase
Gram-negative Bacteria Drug: colimycin Phase 1

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Poitiers University Hospital:

Enrollment: 200
Study Start Date: May 2009
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who received Colistin within 7 days prior to its inclusion, whatever the dosage or the route of administration
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060891


Locations
France
Poitiers University Hospital - 2 rue de la Milétrie
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT01060891     History of Changes
Other Study ID Numbers: COLI-POP
First Submitted: January 29, 2010
First Posted: February 2, 2010
Last Update Posted: October 11, 2016
Last Verified: October 2016

Keywords provided by Poitiers University Hospital:
patients infected with with multiresistant gram-negative bacteria