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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase

Completed

Phase 1

Conditions

Critical Illness

Treatments

Drug: Colistin 6 million units + 240mg/8h

Drug: Colistin 6 million units + 360mg/12h

Study type

Interventional

Funder types

Other

Identifiers

NCT02408185

MagicBullet/COLPHAR

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.