CompletedNCT02408185COLPHARUpdated Feb 3, 2016

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

A Phase 1 interventional study of Colistin 6 million units + 240mg/8h and Colistin 6 million units + 360mg/12h in Critical Illness, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-03.

Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 studied

Critical Illness

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Keywords

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

In context

Critical Illness

1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 1,003 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.

Browse Fundación Pública Andaluza para la gestión de la Investigación en Sevilla studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 20 participants (actual)

Study arms

Experimental
Colistin 6 million units + 240mg/8h
Loading dose of 6 million units of colistin+ 240mg/8h maintenance
Drug: Colistin 6 million units + 240mg/8h
Experimental
Colistin 6 million units + 360mg/12h
Loading dose of 6 million units of colistin+ 360mg/12h maintenance
Drug: Colistin 6 million units + 360mg/12h

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)
Also known as: colistin methanesulfonate (CMS), colistin base activity (CBA)
DrugColistin 6 million units + 360mg/12h
360 mg CMS every 12 hours (4.5 MU; 135 mg CBA)
Also known as: colistin methanesulfonate (CMS), colistin base activity (CBA)

What researchers measure

Primary outcomes

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
Time frame: Day 1 and day 3 after treatment

Secondary outcomes

Number of drug adverse reactions
All study drug related adverse reactions will be gathered and communicated.
Time frame: 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)
"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

Study locations

1 site

Hospital Universitario Virgen del Rocío
Seville, Seville 41013, Spain

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2011, a primary completion of Oct 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 23, 2015
First posted: Apr 3, 2015
Start: Oct 2011
Primary completionActual: Oct 2013
CompletionActual: Oct 2013
Last update: Feb 3, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02408185
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Responsible party: Sponsor
First posted: Apr 3, 2015
Start date: Oct 2011
Primary completion: Oct 2013
Completion: Oct 2013
Last update: Feb 3, 2016

Study contacts

M. Eugenia Pachón, BD-PhD

principal investigator · Instituto de Biomedicina de Sevilla (IBIS)

José Miguel Cisneros, MD-PhD

study chair · Hospitales Universitarios Virgen del Rocío

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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