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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colistin 6 million units + 240mg/8h

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

Group Type EXPERIMENTAL

Colistin 6 million units + 240mg/8h

Intervention Type DRUG

240 mg of colistin methanesulfonate (CMS) every 8 hours, 3 million units (MU); 90 mg colistin base activity, (CBA)

Colistin 6 million units + 360mg/12h

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

Group Type EXPERIMENTAL

Colistin 6 million units + 360mg/12h

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Colistin 6 million units + 360mg/12h

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

Intervention Type DRUG

Other Intervention Names

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colistin methanesulfonate (CMS) colistin base activity (CBA) colistin methanesulfonate (CMS) colistin base activity (CBA)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No