Critical IllnessPhase 1COLPHARNCT02408185
Optimization Dose Study on Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients
A Phase 1 study testing Colistin 6 million units + 240mg/8h and Colistin 6 million units + 360mg/12h in people with Critical Illness, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Colistin 6 million units + 240mg/8h and Colistin 6 million units + 360mg/12h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients With Severe Infections for Dose Optimization Study
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
- Being tested
- Colistin 6 million units + 240mg/8h, Colistin 6 million units + 360mg/12h
- Keywords
- infections, multidrug resistant Gram negative bacteria (MDR-GNB), Skin infections, Pneumonia, Bacteriemia, Nosocomial infections
- Medical subject headings
- Critical Illness, Infections, Cellulitis, Pneumonia, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistin 6 million units + 240mg/8hDrug
Also called colistin methanesulfonate (CMS), colistin base activity (CBA)
240 mg of colistin methanesulfonate (CMS) every 8 hours, 3 million units (MU); 90 mg colistin base activity, (CBA)
Colistin 6 million units + 360mg/12hDrug
Also called colistin methanesulfonate (CMS), colistin base activity (CBA)
360 mg CMS every 12 hours (4.5 MU; 135 mg CBA)
| Study group | Role | What they receive |
|---|---|---|
| Colistin 6 million units + 240mg/8h | Experimental | Loading dose of 6 million units of colistin+ 240mg/8h maintenance Receives: 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 Receives: Drug: Colistin 6 million units + 360mg/12h |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 and day 3 after treatment
Secondary outcomes (2)
Number of drug adverse reactions
All study drug related adverse reactions will be gathered and communicated.
Measured: 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
Measured: Day 1 and day 3 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408185
- Sponsor's protocol ID
- MagicBullet/COLPHAR
- Acronym
- COLPHAR
- Status last verified
- Feb 2016
- First submitted
- 23 Mar 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Colistin in Critically Ill Patients With Severe Infections for Dose Optimization Study
- ClinicalTrials.gov ID
- NCT02408185
- Acronym / sponsor ID
- COLPHAR / MagicBullet/COLPHAR
- Conditions
- Critical Illness
- Keywords
- infections, multidrug resistant Gram negative bacteria (MDR-GNB), Skin infections, Pneumonia, Bacteriemia, Nosocomial infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colistin 6 million units + 240mg/8h | Experimental | Drug: Colistin 6 million units + 240mg/8hLoading dose of 6 million units of colistin+ 240mg/8h maintenance |
| Colistin 6 million units + 360mg/12h | Experimental | Drug: Colistin 6 million units + 360mg/12hLoading dose of 6 million units of colistin+ 360mg/12h maintenance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colistin 6 million units + 240mg/8hAlso: colistin methanesulfonate (CMS), colistin base activity (CBA)240 mg of colistin methanesulfonate (CMS) every 8 hours, 3 million units (MU); 90 mg colistin base activity, (CBA) | Drug | Colistin 6 million units + 240mg/8h |
| Colistin 6 million units + 360mg/12hAlso: colistin methanesulfonate (CMS), colistin base activity (CBA)360 mg CMS every 12 hours (4.5 MU; 135 mg CBA) | Drug | Colistin 6 million units + 360mg/12h |
Primary outcome
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
2 secondary outcomes
Number of drug adverse reactions
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)
Time frame: Day 1 and day 3 after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colistin 6 million units + 240mg/8h and Colistin 6 million units + 360mg/12h in people with Critical Illness, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile; Cmax (maximum reach concentration)/ MIC( Minimum inhibitory concentration) >10 (time frame: Day 1 and day 3 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.