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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02408185

Acronym

COLPHAR

Enrollment

Registered

2015-04-03

Start date

2011-10-31

Completion date

2013-10-31

Last updated

2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

infections, multidrug resistant Gram negative bacteria (MDR-GNB), Skin infections, Pneumonia, Bacteriemia, Nosocomial infections

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.

Interventions

DRUGColistin 6 million units + 240mg/8h

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

DRUGColistin 6 million units + 360mg/12h

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026