- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02142075
Population Pharmacokinetic (PK) Study of Multiple Doses of Cubicin® (Daptomycin) 10 mg/kg in Critical Care Patients Having Bacteremia, Endocarditis or Skin Soft Tissue Infections Due to Gram Positive Bacteria With Various Degrees of Renal Failure (DAPTOREA)
Treatment of infections in critically ill patients remains a significant challenge to intensivists world-wide with persisting high mortality and morbidity. Compelling evidence suggests that source control of the pathogen and appropriate antibiotic therapy remain the most important interventions to improve patients' outcome, the latter including the administration of a suitable molecule at an optimized dosage regimen.
Daptomycin is the first representative of a new family of antibiotics, the cyclic lipopeptides. Its bactericidal effect against Gram-positive bacteria, including meticillin-resistant strains, and its low renal toxicity, make it a useful antibiotic in critically ill patients having infections due to resistant Gram positive strains.
Unfortunately, no PK study has been performed in infected critically ill patients without renal replacement therapy. A vast array of pathophysiological changes can occur in infected critically ill patients, leading to changes in volume of distribution and clearance of antibiotics in these patients, which may affect the antibiotic concentration at the target site.
It is therefore important to better characterize daptomycin PK in infected patients with various degrees of renal failure in order to define optimal dosing regimens.
This project aims to identify optimal daptomycin administration schemes in critical care patients with various degrees of renal impairment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Angers, France, 49933
- Lasocki S, University Hospital of Angers
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Nantes, France, 44093
- Asehnoune K, University Hospital of Nantes
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Rennes, France, 35033
- Seguin P, University Hospital of Rennes
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Tours, France, 37170
- Ferrandiere M, University Hospital of Tours
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients of two sexes aged 18 to 85 years,
- Hospitalized in one of the intensive care unit participating in the study,
- Under mechanical ventilation,
- Having skin or soft tissue infection, bacteremia or endocarditis caused by Gram positivebacteria susceptible to daptomycin,
- Having given written consent to participate to the study.
- Patients with severe sepsis and septic shock will also be included because it's the very population that may benefit from daptomycin treatment and it's important to get data for these patients in order to optimize their treatment.
Exclusion Criteria:
- Pregnant or lactating women
- Obese subjects (body mass index > 40 mg/m2)
- Patients requiring extrarenal replacement therapy,
- Patients having already received daptomycin during the 21 days prior to inclusion,
- Known hypersensitivity to daptomycin,
- History of myopathy
- creatine phosphokinase >5 upper limit of normal
- Patients not affiliated to a social security scheme,Patients deprived of their liberty by judicial or administrative decision
Study Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daptomycin, IV
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
area under the curve / minimum inhibitory concentration ratio of distribution and elimination of daptomycin in plasma and urine
Time Frame: 12 months
|
12 months
|
Cmin and Cmax of distribution and elimination of daptomycin in plasma and urine
Time Frame: 12 months
|
12 months
|
volume of distribution of daptomycin in plasma and urine
Time Frame: 12 months
|
12 months
|
clearance of distribution and elimination of daptomycin in plasma and urine
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the clinical and microbiological efficacy during Daptomycine treatment and two weeks after the end of it
Time Frame: 12 months
|
Patients will be considered to have clinical failure if they will have no response to the study drug on the basis of ongoing signs and symptoms of infection.
Otherwise, patients will be considered to have clinical success.
|
12 months
|
renal and muscular tolerance during Daptomycin treatment and two weeks after the end of it
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAPTOREA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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