Renal FailurePhase 3DAPTOREANCT02142075
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
A Phase 3 study testing Daptomycin in people with Renal Failure and Critical Care, run by Poitiers University Hospital at 4 sites in France.
Trial summary
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'… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Failure, Critical Care, Gram Positive Bacteria
- What is being tested?
- Daptomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 4 sitesFrance
- Study dates
- Mar 2014to Sep 2015
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Lasocki S, University Hospital of Angers
Angers, France, 49933
Asehnoune K, University Hospital of Nantes
Nantes, France, 44093
Seguin P, University Hospital of Rennes
Rennes, France, 35033
Ferrandiere M, University Hospital of Tours
Tours, France, 37170
About this study
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.
Read more
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
- Conditions
- Renal Failure, Critical Care, Gram Positive Bacteria
- Being tested
- Daptomycin
- Keywords
- Pharmacokinetics
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| Daptomycin, IV | Experimental | * Patients with creatinine clearance ≥30 ml/min will receive 10 mg/kg of daptomycin (Cubicin®) once daily,
* Patients with creatinine clearance <30 ml/min will receive the same daptomycin dose (10 mg/kg) but less frequently, every 48h instead of every day Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve / minimum inhibitory concentration ratio of distribution and elimination of daptomycin in plasma and urine
Measured: 12 months
Cmin and Cmax of distribution and elimination of daptomycin in plasma and urine
Measured: 12 months
volume of distribution of daptomycin in plasma and urine
Measured: 12 months
clearance of distribution and elimination of daptomycin in plasma and urine
Measured: 12 months
Secondary outcomes (2)
the clinical and microbiological efficacy during Daptomycine treatment and two weeks after the end of it
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.
Measured: 12 months
renal and muscular tolerance during Daptomycin treatment and two weeks after the end of it
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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 3
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142075
- Sponsor's protocol ID
- DAPTOREA
- Acronym
- DAPTOREA
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2014
- Last updated
- 11 Oct 2016
- Results posted
- No
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 (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
- ClinicalTrials.gov ID
- NCT02142075
- Acronym / sponsor ID
- DAPTOREA / DAPTOREA
- Conditions
- Renal Failure, Critical Care, Gram Positive Bacteria
- Keywords
- Pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- First posted
- 20 May 2014 (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.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daptomycin, IV | Experimental | Drug: Daptomycin* Patients with creatinine clearance ≥30 ml/min will receive 10 mg/kg of daptomycin (Cubicin®) once daily, * Patients with creatinine clearance <30 ml/min will receive the same daptomycin dose (10 mg/kg) but less frequently, every 48h instead of every day |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
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 |
|---|---|---|
| Daptomycin | Drug | Daptomycin, IV |
Primary outcome
area under the curve / minimum inhibitory concentration ratio of distribution and elimination of daptomycin in plasma and urine
Time frame: 12 months
Cmin and Cmax of distribution and elimination of daptomycin in plasma and urine
Time frame: 12 months
volume of distribution of daptomycin in plasma and urine
Time frame: 12 months
clearance of distribution and elimination of daptomycin in plasma and urine
Time frame: 12 months
2 secondary outcomes
the clinical and microbiological efficacy during Daptomycine treatment and two weeks after the end of it
Time frame: 12 months
renal and muscular tolerance during Daptomycin treatment and two weeks after the end of it
Time frame: 12 months
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.
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daptomycin in people with Renal Failure and Critical Care, run by Poitiers University Hospital at 4 sites 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 6 inclusion and 8 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 4 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
area under the curve / minimum inhibitory concentration ratio of distribution and elimination of daptomycin in plasma and urine (time frame: 12 months). The study lists 4 primary outcomes in all. 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 11 Oct 2016.