Trial | NCT02408185  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    colistin ...

  • Study Participants

    20
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.
Study Started
Oct 31
2011
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Feb 03
2016
Estimate

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)

  • Other names: colistin methanesulfonate (CMS), colistin base activity (CBA)

Drug Colistin 6 million units + 360mg/12h

360 mg CMS every 12 hours (4.5 MU; 135 mg CBA)

  • Other names: colistin methanesulfonate (CMS), colistin base activity (CBA)

Colistin 6 million units + 240mg/8h Experimental

Loading dose of 6 million units of colistin+ 240mg/8h maintenance

Colistin 6 million units + 360mg/12h Experimental

Loading dose of 6 million units of colistin+ 360mg/12h maintenance

Criteria 

Inclusion Criteria:

More than 60 Kg of weigh
Patients with directed treatment with colistin as the recommended antimicrobial treatment protocols in the hospital to treat some of the following serious infections caused by carbapenems resistant A. baumannii: (i) bacteremia; (ii) nosocomial pneumonia or (iii) infection of skin and soft tissue (cellulitis, abscesses or infected ulcers).
Written informed consent form.

Exclusion Criteria:

Refractory shock or other illness with an expectative of life ˂ 48 hours after the recruitment;
Patient declared not to resuscitation maneuvers;
Suspicion or demonstration of endocarditis, osteomyelitis, or meningitis;
Known hypersensitivity to polymyxins;
Pregnancy.
No Results Posted