Status:
COMPLETED
Multicentric Study About the Usefulness of Monitoring Plasma Levels of Colistin and Sodium Colistimethate in Patients With Infections Due to Multi-drug Resistant Gram Negative Bacilli, Treated With Colistin
Lead Sponsor:
Parc de Salut Mar
Conditions:
Multidrug Resistant Gram Negative Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objectives: Main objective: to assess the impact of an intervention for optimizing the dosing of colistin based on its plasma levels in patients with infections due to multi-drug resistant gram negati...
Eligibility Criteria
Inclusion
- Male or female ≥18 years of age.
- Hospitalized patients with an active infection caused by MDR-BGN
- Treatment with intravenous CMS for at least 3 consecutive days
- Evidence of a personally signed and dated informed consent document in accordance with local regulatory and legal requirements indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion
- Patients colonized by a MDR-BGN and no signs/symptoms of an active infection
- Treatment with intravenous CMS for least than 3 days
- Patients with polymicrobial infections (with an isolated microorganism different from the MDR-BGN).
- Patients with a glomerular filtration rate at baseline less than 10ml/min or those requiring renal replacement therapies.
- Known history of allergy, hypersensitivity or serious reaction to polymyxins.
- Patients treated with nebulized CMS in addition to intravenous CMS.
- Patients who have already participated in this trial.
- Patients without a personally signed and dated informed consent document
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01845246
Start Date
January 1 2012
End Date
August 1 2015
Last Update
April 12 2017
Active Locations (3)
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1
Hospital del Mar
Barcelona, Barcelona, Spain, 08003
2
Hospital de Sant Pau
Barcelona, Barcelona, Spain, 08025
3
Hospital de Granollers
Granollers, Barcelona, Spain, 08400