NCT02408185

Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients

Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients With Severe Infections for Dose Optimization Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II clinical trial, open-labelled, prospective and single-center study directed to obtain blood samples in experimental detailed conditions in order to compare and optimize the dose of colistin in critically ill patients suffering from infections on which the indication of colistin would be accepted according to normal local protocols for severe infections treatment.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DRUG	Colistin 6 million units + 240mg/8h	240 mg of colistin methanesulfonate (CMS) every 8 hours, 3 million units (MU); 90 mg colistin base activity, (CBA)
DRUG	Colistin 6 million units + 360mg/12h	360 mg CMS every 12 hours (4.5 MU; 135 mg CBA)

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2015-04-03
• Last updated: 2016-02-03

Locations

1 site across 1 country: Spain