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OpenTrials
Completed

NCT Number: NCT01060891

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Poitiers University Hospital - 2 rue de la Milétrie

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colimycin

Drug

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
First posted
Feb 2, 2010
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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