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

NCT02408185 | Completed Phase 1

• 1 other identifier: MagicBullet/COLPHAR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1 and day 3 after treatment

Secondary Outcomes (2)

• Number of drug adverse reactions

  21 days of follow-up

• 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

Study Arms (2)

Colistin 6 million units + 240mg/8h

EXPERIMENTAL

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

Drug: Colistin 6 million units + 240mg/8h

Colistin 6 million units + 360mg/12h

EXPERIMENTAL

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

Drug: Colistin 6 million units + 360mg/12h

Interventions

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)

Also known as: colistin methanesulfonate (CMS), colistin base activity (CBA)

Colistin 6 million units + 240mg/8h

Colistin 6 million units + 360mg/12h DRUG

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

Also known as: colistin methanesulfonate (CMS), colistin base activity (CBA)

Colistin 6 million units + 360mg/12h

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Seville, 41013, Spain

Location

MeSH Terms

Conditions

Critical Illness; Infections; Cellulitis; Pneumonia; Cross Infection

Interventions

colistinmethanesulfonic acid

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease

Study Officials

• M. Eugenia Pachón, BD-PhD

  Instituto de Biomedicina de Sevilla (IBIS)

  PRINCIPAL INVESTIGATOR

• José Miguel Cisneros, MD-PhD

  Hospitales Universitarios Virgen del Rocío

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 3, 2015
• Study Start: October 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 3, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)