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

Phase 1

Completed

• Conditions: Critical Illness
• Interventions: Drug: Colistin 6 million units + 240mg/8h; Drug: Colistin 6 million units + 360mg/12h

• Registration Number: NCT02408185
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colistin 6 million units + 240mg/8h	Colistin 6 million units + 240mg/8h	Loading dose of 6 million units of colistin+ 240mg/8h maintenance
Colistin 6 million units + 360mg/12h	Colistin 6 million units + 360mg/12h	Loading dose of 6 million units of colistin+ 360mg/12h maintenance

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10	Day 1 and day 3 after treatment	Plasma concentration will be measured for pharmacokinetic and pharmacodynamic profile the samples were drawn at 60, 120, 180, 240, 360, and 480 min after the end of the loading dose infusion and in patients of the group B, two more samples are taken at 600 and 720 min after the loading dose. Main pharmacokinetic parameters will be Cmax (maximum reach concentration)/ MIC(Minimum inhibitory concentration)\>10

Secondary Outcome Measures

Name	Time	Method
Number of drug adverse reactions	21 days of follow-up	All study drug related adverse reactions will be gathered and communicated.
Pharmacodynamic profile ("Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation)	Day 1 and day 3 after treatment	"Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío; 🇪🇸 Seville, Spain