NCT01060891

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gram-negative Bacteria

Interventions

Type	Name	Description
DRUG	colimycin

Timeline

• Start date: 2009-05-01
• Primary completion: 2015-04-01
• First posted: 2010-02-02
• Last updated: 2016-10-11

Locations

1 site across 1 country: France