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Completed

NCT Number: NCT02408185

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

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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Key information

Conditions

Critical Illness Cellulitis Connective Tissue Diseases Cross Infection Disease Attributes Iatrogenic Disease Infections Inflammation Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colistin 6 million units + 240mg/8h

Drug

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)

Colistin 6 million units + 360mg/12h

Drug

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

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

Primary outcomes

  1. Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10

    Time frame: 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 outcomes

  1. Number of drug adverse reactions

    Time frame: 21 days of follow-up

    All study drug related adverse reactions will be gathered and communicated.

  2. Pharmacodynamic profile ("Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study title

Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients With Severe Infections for Dose Optimization Study

Acronym: COLPHAR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 3, 2015
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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