Gram-Positive Bacterial InfectionsPhase 2NCT01212432
Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
A Phase 2 study testing Daptomycin in people with Gram-Positive Bacterial Infections, run by University of Zurich at 1 site in Switzerland.
Trial summary
Daptomycin kinetics in CRRT Trial with medicinal product Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gram-Positive Bacterial Infections
- What is being tested?
- Daptomycin
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2009to Mar 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
- Life expectancy of less than 5 days
Trial locations and contacts
1 site in 1 country.
01 Studienregister MasterAdmins contact
About this study
Daptomycin kinetics in CRRT
- Trial with medicinal product
- Conditions
- Gram-Positive Bacterial Infections
- Being tested
- Daptomycin
- Keywords
- Gram positive infection and CRRT
- Medical subject headings
- Gram-Positive Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Daptomycin kinetics in CRRT
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startDec 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-Positive Bacterial InfectionsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212432
- Sponsor's protocol ID
- DAPTO_CH08
- Status last verified
- Jul 2010
- First submitted
- 29 Sep 2010
- Last updated
- 18 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 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 Finding Study
- ClinicalTrials.gov ID
- NCT01212432
- Acronym / sponsor ID
- DAPTO_CH08
- Conditions
- Gram-Positive Bacterial Infections
- Keywords
- Gram positive infection and CRRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 30 Sep 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.
Daptomycin kinetics in CRRT
- Trial with medicinal product
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
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 |
|---|---|---|
| DaptomycinDaptomycin kinetics in CRRT | Drug | – |
Primary outcome
Pharmacokinetics
Time frame: 2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 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.
01 Studienregister MasterAdmins contact
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
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 Gram-Positive Bacterial Infections, 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 18 Oct 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?
Contact 01 Studienregister MasterAdmins (+41 (0)44 255 11 11), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (time frame: 2011). 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 18 Oct 2010.