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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01060891
First received: January 29, 2010
Last updated: February 1, 2010
Last verified: January 2010
History of Changes
  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:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Poitiers University Hospital:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060891

Contacts
Contact: Olivier MIMOZ 0549444600 o.mimoz@chu-poitiers.fr

Locations
France
Poitiers University Hospital - 2 rue de la Milétrie Recruiting
Poitiers, France, 86021
Contact: Olivier Mimoz, MD     0549444600        
Sponsors and Collaborators
Poitiers University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01060891     History of Changes
Other Study ID Numbers: COLI-POP
Study First Received: January 29, 2010
Last Updated: February 1, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Colistin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013