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

Primary Purpose

Critical Illness

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Colistin 6 million units + 240mg/8h
Colistin 6 million units + 360mg/12h
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring infections, multidrug resistant Gram negative bacteria (MDR-GNB), Skin infections, Pneumonia, Bacteriemia, Nosocomial infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Colistin 6 million units + 240mg/8h

Colistin 6 million units + 360mg/12h

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Number of drug adverse reactions
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)
"Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation

Full Information

First Posted
March 23, 2015
Last Updated
February 2, 2016
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT02408185
Brief Title
Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients
Acronym
COLPHAR
Official Title
Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients With Severe Infections for Dose Optimization Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
infections, multidrug resistant Gram negative bacteria (MDR-GNB), Skin infections, Pneumonia, Bacteriemia, Nosocomial infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colistin 6 million units + 240mg/8h
Arm Type
Experimental
Arm Description
Loading dose of 6 million units of colistin+ 240mg/8h maintenance
Arm Title
Colistin 6 million units + 360mg/12h
Arm Type
Experimental
Arm Description
Loading dose of 6 million units of colistin+ 360mg/12h maintenance
Intervention Type
Drug
Intervention Name(s)
Colistin 6 million units + 240mg/8h
Other Intervention Name(s)
colistin methanesulfonate (CMS), colistin base activity (CBA)
Intervention Description
240 mg of colistin methanesulfonate (CMS) every 8 hours, 3 million units (MU); 90 mg colistin base activity, (CBA)
Intervention Type
Drug
Intervention Name(s)
Colistin 6 million units + 360mg/12h
Other Intervention Name(s)
colistin methanesulfonate (CMS), colistin base activity (CBA)
Intervention Description
360 mg CMS every 12 hours (4.5 MU; 135 mg CBA)
Primary Outcome Measure Information:
Title
Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10
Description
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
Time Frame
Day 1 and day 3 after treatment
Secondary Outcome Measure Information:
Title
Number of drug adverse reactions
Description
All study drug related adverse reactions will be gathered and communicated.
Time Frame
21 days of follow-up
Title
Pharmacodynamic profile ("Monte-Carlo simulation" (statistical methodology) with MIC (Minimum inhibitory concentration) 50 y MIC (Minimum inhibitory concentration) 90 from samples isolation)
Description
"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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Eugenia Pachón, BD-PhD
Organizational Affiliation
Instituto de Biomedicina de Sevilla (IBIS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Miguel Cisneros, MD-PhD
Organizational Affiliation
Hospitales Universitarios Virgen del Rocío
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío
City
Seville
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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