BacteremiaPhase 2NCT01171547
Daptomycin Pharmacokinetics in Continuous Veno-venous Hemodiafiltration
A Phase 2 study testing Daptomycin in people with Bacteremia, run by University of Zurich at 1 site in Switzerland.
Trial summary
The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bacteremia
- What is being tested?
- Daptomycin
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2010to Feb 2010
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female of 18 years or older
- females: negative pregnancy test
- Hospitalisation in the medical ICU
- High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
- Subjects receiving standard antibiotic treatment for Gram-positive infection
- Evidence of renal failure
- Clinical necessity for continuous renal replacement therapy
- Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.
Who cannot join
- Skeletal muscle disorders or CPK levels of > 2 x ULN
- History of hypersensitivity to the drug
- Participation in another study
- Subjects with a history of muscle disease
- Patients with severe liver function impairment (Child C)
- Life expectancy of less than 5 days
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Medical Intensive Care Unit, University Hospital Zurich
Zurich, Canton of Zurich, 8091
Maggiorini, Prof, marco.maggiorini@usz.ch
About this study
Official title: Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.
- Conditions
- Bacteremia
- Being tested
- Daptomycin
- Keywords
- pharmacokinetics
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
once daily over 5 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
15 patients are devided in 3 cohorts of 5 patients each. PK data(measured on day 1, 3 and 5) of the first 5 patients receiving daptomycin 6mg/kg/day during 5 consecutive days additionally to standard antibiotic treatment are compared with PK data of daptomycin 6mg/kg/day in healthy volunteers and dose is adapted in the next 5 patients based on these results. The same is done for the last 5 patients.
Measured: PK on days 1, 3, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171547
- Sponsor's protocol ID
- EK-1632
- Status last verified
- Jul 2010
- First submitted
- 22 Jul 2010
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Find Study
- ClinicalTrials.gov ID
- NCT01171547
- Acronym / sponsor ID
- EK-1632
- Conditions
- Bacteremia
- Keywords
- pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (estimated)
- First posted
- 28 Jul 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.
The purpose is to investigate daptomycin pharmacokinetics in critically ill patients with suspected or verified bacteremia with Gram-positive cocci undergoing combined continuous hemodiafiltration at a filtration rate of 35ml/kg/h and to establish a dose recommendation for continuous hemodiafiltration at a filtrate rate of 35ml/kg/h.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male or female of 18 years or older
- females: negative pregnancy test
- Hospitalisation in the medical ICU
- High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
- Subjects receiving standard antibiotic treatment for Gram-positive infection
Key exclusion criteria (6 listed)
- Skeletal muscle disorders or CPK levels of > 2 x ULN
- History of hypersensitivity to the drug
- Participation in another study
- Subjects with a history of muscle disease
- Patients with severe liver function impairment (Child C)
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 |
|---|---|---|
| Daptomycinonce daily over 5 days | Drug | – |
Primary outcome
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing.
Time frame: PK on days 1, 3, and 5
15 patients are devided in 3 cohorts of 5 patients each. PK data(measured on day 1, 3 and 5) of the first 5 patients receiving daptomycin 6mg/kg/day during 5 consecutive days additionally to standard antibiotic treatment are compared with PK data of daptomycin 6mg/kg/day in healthy volunteers and dose is adapted in the next 5 patients based on these results. The same is done for the last 5 patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daptomycin in people with Bacteremia, run by University of Zurich at 1 site in Switzerland.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jul 2010. 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of daptomycin plasmaconcentrations and pharmacokinetics in 15 patients with gram positive infection undergoing CRRT do determine adequate dosing. (time frame: PK on days 1, 3, and 5). 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 28 Jul 2010.