Gram-negative BacteriaPhase 1NCT01060891
Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria
A Phase 1 study testing colimycin in people with Gram-negative Bacteria, run by Poitiers University Hospital at 1 site in France.
Trial summary
Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-negative Bacteria
- What is being tested?
- colimycin
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- May 2009to Apr 2015
- 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
- Age: 18 to 85 years
- Patients with nosocomial infection justifying Colistin.
Who cannot join
- Patients who received Colistin within 7 days prior to its inclusion, whatever the dosage or the route of administration
- Known hypersensitivity to Colistin or products of the polymyxin family
- Personal and family history for myasthenia
- Positive serology for HBV, HCV and HIV
- Positive pregnancy test or currently lactating
Trial locations and contacts
1 site in 1 country.
France1 site
Poitiers University Hospital - 2 rue de la Milétrie
Poitiers, 86021
About this study
Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria
- Conditions
- Gram-negative Bacteria
- Being tested
- colimycin
- Keywords
- patients infected with with multiresistant gram-negative bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colimycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2009
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-negative BacteriaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060891
- Sponsor's protocol ID
- COLI-POP
- Status last verified
- Oct 2016
- First submitted
- 29 Jan 2010
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Boisson M, Gregoire N, Cormier M, Gobin P, Marchand S, Couet W, Mimoz O. Pharmacokinetics of nebulized colistin methanesulfonate in critically ill patients. J Antimicrob Chemother. 2017 Sep 1;72(9):2607-2612. doi: 10.1093/jac/dkx167.
PubMed 28575278
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetic Study of Colistin in Patients Infected With Multiresistant Gram-negative Bacteria
- ClinicalTrials.gov ID
- NCT01060891
- Acronym / sponsor ID
- COLI-POP
- Conditions
- Gram-negative Bacteria
- Keywords
- patients infected with with multiresistant gram-negative bacteria
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2015 (actual)
- First posted
- 2 Feb 2010 (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.
Nosocomial infections have become a major health problem. They induced important use of antibiotics which is a preponderant factor for the development of bacterial resistance. The multi-resistance to antibiotics affects primarily Gram-negative bacteria. Some strains (as Acinetobacter or Pseudomonas) have become resistant to almost all antibiotics currently available, and the use of old molecules as Colistin may be the only alternative. However, there are few reliable data about Colistin and its PK characteristics. These data are essential to optimize its administration. The aim of the present study is to evaluate the pharmacokinetics of Colistin and its prodrug, colistimethate (CMS) after intravenous administration of Colistimethate alone or combined with inhaled Colistin in severely ill patients infected with multiresistant gram-negative bacteria
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 18 to 85 years
- Patients with nosocomial infection justifying Colistin.
Key exclusion criteria (5 listed)
- Patients who received Colistin within 7 days prior to its inclusion, whatever the dosage or the route of administration
- Known hypersensitivity to Colistin or products of the polymyxin family
- Personal and family history for myasthenia
- Positive serology for HBV, HCV and HIV
- Positive pregnancy test or currently lactating
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 |
|---|---|---|
| colimycin | Drug | – |
Primary outcome
Not reported in the source record.
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 11 Oct 2016.
- Derived from this study: PubMed 28575278Boisson M, Gregoire N, Cormier M, Gobin P, Marchand S, Couet W, Mimoz O. Pharmacokinetics of nebulized colistin methanesulfonate in critically ill patients. J Antimicrob Chemother. 2017 Sep 1;72(9):2607-2612. doi: 10.1093/jac/dkx167.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 colimycin in people with Gram-negative Bacteria, run by Poitiers University Hospital at 1 site in France.
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 2 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 11 Oct 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 France. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01060891, which also lists 1 linked publication.
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 11 Oct 2016.