drugset / Trial / NCT01060891

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

NCT01060891

Phase 1 Completed 200 enrolled Poitiers University Hospital

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

Timeline

Start
2009-05
Primary completion
2015-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Colistin Other / unclassified 500000 iu Intravenous