Critically IllPhase 4NCT00663403
Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)
A Phase 4 study testing Daptomycin in people with Critically Ill and Hemodialysis, run by University of Michigan at 1 site in United States.
Trial summary
Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Hemodialysis
- What is being tested?
- Daptomycin
- Type of treatment
- Injection or infusion
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- =/> 18 years of age
- Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary physician
- Prescribed daptomycin as determined by the primary physician
- Informed consent granted
Who cannot join
- < 18 years of age
- Allergy to daptomycin
- Patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections
- Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)
- Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
- Inability to obtain informed consent
- Pregnant and/or breastfeeding women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan University Hospital
Ann Arbor, Michigan, 48109
About this study
Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.
Read the detailed description
Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.
- Conditions
- Critically Ill, Hemodialysis
- Being tested
- Daptomycin
- Keywords
- daptomycin, pharmacokinetics, renal replacement therapy, critical illness, intensive care units
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
Daptomcyin 8 mg/kg infused intravenously every 48 hours
What is being measured
The primary outcome is the main question the study is designed to answer.
Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis
Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.
Measured: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Secondary outcomes (6)
Daptomycin Dose Actually Administered
Measured: Time of daptomycin administration
Observed Daptomycin Peak Serum Concentration
The maximum concentration of daptomycin in the body after receiving a dose of the drug. This was determined at the end of the daptomycin intravenous infusion at approximately 30 min.
Measured: At the end of the daptomycin intravenous infusion (at approximately 30 minutes)
Daptomycin Volume of Distribution at Steady State
Volume of distribution quantifies the distribution of daptomycin between the blood and the rest of the body. The greater the volume of distribtion, the greater the extent of daptomycin distribution throughout the body.
Measured: From time of daptomycin administration to 48 hours post dose
Daptomycin Total Body Clearance
Total body clearance represents the rate at which daptomycin is removed from the body. In patients treated with continuous venovenous hemodialysis, the major pathways of daptomycin removal likely are: removal by continuuous venovenous hemodialysis (transmembrane clearance) and breakdown by the liver.
Measured: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Half-life
Half-life describes the time it takes for the concentration of the daptomycin in the body to decrease by one half.
Measured: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Free Fraction
In the body, daptomcyin may be bound to proteins in the blood or it may not be bound to any proteins (also as the "free" component.) Free fraction describes the percent of daptomycin that is unbound or free. The unbound portion of daptomycin is able to kill bacteria.
Measured: From time of daptomycin administration to 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Investigators
- Bruce A Mueller, PharmD, Principal investigator, University of Michigan, College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663403
- Sponsor's protocol ID
- 063940
- Other IDs
- HUM00005646
- Status last verified
- May 2009
- First submitted
- 18 Apr 2008
- Last updated
- 30 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Vilay AM, Grio M, Depestel DD, Sowinski KM, Gao L, Heung M, Salama NN, Mueller BA. Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis. Crit Care Med. 2011 Jan;39(1):19-25. doi: 10.1097/CCM.0b013e3181fa36fb.
PubMed 20890189
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Daptomycin in Critically Ill Patients Receiving Continuous Venovenous Hemodialysis (CVVHD)
- ClinicalTrials.gov ID
- NCT00663403
- Acronym / sponsor ID
- 063940
- Conditions
- Critically Ill, Hemodialysis
- Keywords
- daptomycin, pharmacokinetics, renal replacement therapy, critical illness, intensive care units
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Feb 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Posted 26 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Daptomycin is an antibiotic that is affective against many strains of antibiotic resistant microorganisms. This antibiotic would be appropriate for use in the intensive care unit (ICU) considering the severity of illness and high risk for infection within this hospital environment. While in the ICU, patients may develop acute renal failure. Approximately 75% of ICU patients who develop acute renal failure will require some form of renal replacement therapy until their kidneys recover. Continuous hemodialysis is becoming one of the most common forms of dialysis in the ICU as it is a gentle type of dialysis provided over longer periods of time. The current data demonstrating the ability of continuous hemodialysis to remove daptomycin from the body is derived from in-vitro trials. The purpose of this trial is to determine the extent of daptomycin removal from critically ill patients receiving continuous hemodialysis. Findings from this trial will be used to develop new dosing recommendations for daptomycin in continuous hemodialysis.
Detailed description
Daptomycin is a FDA approved antibiotic. This pharmacokinetic trial will monitor daptomycin drug concentrations during continuous hemodialysis. The daptomycin concentration profiles developed from this study will assist in developing a dose recommendation that will result in daptomycin levels that are safe and within therapeutic ranges, as previously identified, in critically ill patients with acute renal failure treated with continuous hemodialysis.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- =/> 18 years of age
- Prescribed Continuous Venovenous Hemodialysis (CVVHD) as determined by the primary physician
- Prescribed daptomycin as determined by the primary physician
- Informed consent granted
Key exclusion criteria (7 listed)
- < 18 years of age
- Allergy to daptomycin
- Patients being primarily treated with daptomycin for diagnosis of osteomyelitis, meningitis, or pneumonia without adequate concomitant use of other more effective antimicrobial agents as daptomycin is not indicated for primary treatment of these types of infections
- Inability to complete 48 hours of Continuous Venovenous Hemodialysis (CVVHD)
- Concurrent use of other extracorporeal therapies such as Extracorporeal Membrane Oxygenation (ECMO) or plasmapheresis and intermittent hemodialysis
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 |
|---|---|---|
| DaptomycinAlso: CubicinDaptomcyin 8 mg/kg infused intravenously every 48 hours | Drug | – |
Primary outcome
Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis
Time frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Quantifies the rate of daptomcyin removal by continuous venovenous hemodialysis.
6 secondary outcomes
Daptomycin Dose Actually Administered
Time frame: Time of daptomycin administration
Observed Daptomycin Peak Serum Concentration
Time frame: At the end of the daptomycin intravenous infusion (at approximately 30 minutes)
Daptomycin Volume of Distribution at Steady State
Time frame: From time of daptomycin administration to 48 hours post dose
Daptomycin Total Body Clearance
Time frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Half-life
Time frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis
Daptomycin Free Fraction
Time frame: From time of daptomycin administration to 48 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20890189Vilay AM, Grio M, Depestel DD, Sowinski KM, Gao L, Heung M, Salama NN, Mueller BA. Daptomycin pharmacokinetics in critically ill patients receiving continuous venovenous hemodialysis. Crit Care Med. 2011 Jan;39(1):19-25. doi: 10.1097/CCM.0b013e3181fa36fb.
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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.
Bruce A Mueller, PharmD principal investigator
University of Michigan, College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daptomycin in people with Critically Ill and Hemodialysis, run by University of Michigan at 1 site in United States.
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 4 inclusion and 7 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 30 Dec 2015. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daptomycin Transmembrane Clearance by Continuous Venovenous Hemodialysis (time frame: From time of daptomycin administration to 48 hours post dose when subjects were also receiving continuous venovenous hemodialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00663403, which also lists 1 linked publication.
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 30 Dec 2015.