MeningitisNCT01025271
Cerebrospinal Fluid Pharmacokinetics of Daptomycin
A study testing Daptomycin in people with Meningitis, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a prospective pharmacokinetic study in patients having external ventricular drains with suspected external ventricular drain related bacterial meningitis. A single dose of daptomycin will be administered for the purposes of the study and PK samples will be obtained around this dosing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningitis
- What is being tested?
- Daptomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2011
- Phase
- Interventional
- 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
- Adults with suspected EVD related meningitis or ventriculitis who already have an external ventricular drain placed, as part of standard clinical care for CSF drainage, and whose clinicians plan to start antibiotics. There should be a clinical indication for the EVD to be in place for ≥ 72 hrs. An intravenous line which can be accessed for blood draws should be present.
Who cannot join
- Age less than 18 years of age Patient is a woman who is pregnant or lactating Allergies or prior adverse reactions to daptomycin, which would preclude its use.
- Elevated CK levels (>500). Inability to obtain informed consent or get proxy consent. Patients on CRRT (continuous renal replacement therapies) or on dialysis Patients with an estimated CrCl <30 cc/min as estimated by MDRD at base line. Patients with a BMI >30 Any medical condition leading to a life expectancy of < 48 hours, as determined by the clinician.
- Patient who have received a dose of daptomycin in the last 7 days. Patients is participating in other studies
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective pharmacokinetic study in patients having external ventricular drains with suspected external ventricular drain related bacterial meningitis. A single dose of daptomycin will be administered for the purposes of the study and PK samples will be obtained around this dosing.
Read the detailed description
information related to the subject's demographics, past medical history and current medical history will be collected from the medical record. This will be collected by the research coordinator.
The following samples will be obtained by the research coordinator or bedside RN and sent to UPMC laboratory for evaluation.
1 teaspoon of blood for creatinine phosphokinase level will be obtained
pregnancy testing will occur if necessary - 1 teaspoon of blood Screening procedures about 30 minutes of the patient's time includes, medical record review will occur and information related to the patients past medical history, demographics, and present condition, results of present testing will be collected, pregnancy test- 1 teaspoon of blood, creatinine phosphokinase - 1 teaspoon of blood. Additionally another CPK level will be obtained 36 hours post daptomycin infusion. This blood sample is a routine part of your clinical care. The bedside RN or research coordinator will collect the blood samples and send to the lab at UPMC for evaluation and the medical chart review will be completed by research coordinator.
if the patient meets entry criteria the following will occur at the patient's bedside in their room. If there is a clinical indication that requires the catheter to be removed, the removal will not be delayed for the purposes of the research study:
Patient will receive one dose of daptomycin via IV given by the bedside RN over 30 minutes (the dosing will be based on the patient's weight- 10 milligrams per kilogram). PK sampling will be obtained around this dosing. 10 PK samples around dosing of Daptomycin will occur- this will be approximately 11 teaspoons (1 teaspoon per sample) and will be obtained immediately before the Daptomycin dosing, then 1, 2, 4, 8, 10, 16, 24 and 36 hours after the end of infusion. The research coordinator will come to the bedside and the bedside RN will obtain these samples and will be obtained via the patient's existing IV catheter or central line.
4 samples of cerebrospinal fluid approximately 1 teaspoon per sample will be collected on the day daptomycin is given. These samples will be obtained by the bedside RN and taken from the already existing spinal fluid draining catheter.
10 subjects will have these samples obtained 1, 8, 16, 24 after the end of the daptomycin infusion and 10 subjects will have them collected at 2,4, 10 and 36 hours after the end of the daptomycin infusion.
2 days after collection of PK samples the patient will be seen at their bedside to check how well the patient is doing. This will take 5-10 minutes of the patient's time. If the patient is d/c home a research coordinator will call the patient to check on their status again this will take about 5-10 minutes
- Conditions
- Meningitis
- Being tested
- Daptomycin
- Keywords
- meningitis
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
one dose of daptomycin (10 milligrams of the drug per kilogram of the subject's body weight
| Study group | Role | What they receive |
|---|---|---|
| open label | Other | patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin Receives: Drug: Daptomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis
unable to meet enrollment no data available. Study terminated early
Measured: 5 years
Secondary outcomes (1)
Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) to Determine the CSF Penetration and Pharmacokinetic Parameters in This Patient Population (
no analysis completed
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: unable to enroll subjects study stopped due to lack of enrollment
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.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Karin Byers, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025271
- Sponsor's protocol ID
- IRB#: PRO09070202
- Status last verified
- Aug 2013
- First submitted
- 2 Dec 2009
- Last updated
- 12 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrospinal Fluid Pharmacokinetics of Daptomycin
- ClinicalTrials.gov ID
- NCT01025271
- Acronym / sponsor ID
- IRB#: PRO09070202
- Conditions
- Meningitis
- Keywords
- meningitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to enroll subjects study stopped due to lack of enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Dec 2009 (estimated)
- Results
- Posted 12 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective pharmacokinetic study in patients having external ventricular drains with suspected external ventricular drain related bacterial meningitis. A single dose of daptomycin will be administered for the purposes of the study and PK samples will be obtained around this dosing.
Detailed description
information related to the subject's demographics, past medical history and current medical history will be collected from the medical record. This will be collected by the research coordinator.
The following samples will be obtained by the research coordinator or bedside RN and sent to UPMC laboratory for evaluation.
1 teaspoon of blood for creatinine phosphokinase level will be obtained
pregnancy testing will occur if necessary - 1 teaspoon of blood Screening procedures about 30 minutes of the patient's time includes, medical record review will occur and information related to the patients past medical history, demographics, and present condition, results of present testing will be collected, pregnancy test- 1 teaspoon of blood, creatinine phosphokinase - 1 teaspoon of blood. Additionally another CPK level will be obtained 36 hours post daptomycin infusion. This blood sample is a routine part of your clinical care. The bedside RN or research coordinator will collect the blood samples and send to the lab at UPMC for evaluation and the medical chart review will be completed by research coordinator.
if the patient meets entry criteria the following will occur at the patient's bedside in their room. If there is a clinical indication that requires the catheter to be removed, the removal will not be delayed for the purposes of the research study:
Patient will receive one dose of daptomycin via IV given by the bedside RN over 30 minutes (the dosing will be based on the patient's weight- 10 milligrams per kilogram). PK sampling will be obtained around this dosing. 10 PK samples around dosing of Daptomycin will occur- this will be approximately 11 teaspoons (1 teaspoon per sample) and will be obtained immediately before the Daptomycin dosing, then 1, 2, 4, 8, 10, 16, 24 and 36 hours after the end of infusion. The research coordinator will come to the bedside and the bedside RN will obtain these samples and will be obtained via the patient's existing IV catheter or central line.
4 samples of cerebrospinal fluid approximately 1 teaspoon per sample will be collected on the day daptomycin is given. These samples will be obtained by the bedside RN and taken from the already existing spinal fluid draining catheter.
10 subjects will have these samples obtained 1, 8, 16, 24 after the end of the daptomycin infusion and 10 subjects will have them collected at 2,4, 10 and 36 hours after the end of the daptomycin infusion.
2 days after collection of PK samples the patient will be seen at their bedside to check how well the patient is doing. This will take 5-10 minutes of the patient's time. If the patient is d/c home a research coordinator will call the patient to check on their status again this will take about 5-10 minutes
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Other | Drug: Daptomycinpatients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with suspected EVD related meningitis or ventriculitis who already have an external ventricular drain placed, as part of standard clinical care for CSF drainage, and whose clinicians plan to start antibiotics. There should be a clinical indication for the EVD to be in place for ≥ 72 hrs. An intravenous line which can be accessed for blood draws should be present.
Key exclusion criteria (3 listed)
- Age less than 18 years of age Patient is a woman who is pregnant or lactating Allergies or prior adverse reactions to daptomycin, which would preclude its use.
- Elevated CK levels (>500). Inability to obtain informed consent or get proxy consent. Patients on CRRT (continuous renal replacement therapies) or on dialysis Patients with an estimated CrCl <30 cc/min as estimated by MDRD at base line. Patients with a BMI >30 Any medical condition leading to a life expectancy of < 48 hours, as determined by the clinician.
- Patient who have received a dose of daptomycin in the last 7 days. Patients is participating in other studies
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 |
|---|---|---|
| Daptomycinone dose of daptomycin (10 milligrams of the drug per kilogram of the subject's body weight | Drug | open label |
Primary outcome
Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis
Time frame: 5 years
unable to meet enrollment no data available. Study terminated early
1 secondary outcome
Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) to Determine the CSF Penetration and Pharmacokinetic Parameters in This Patient Population (
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karin Byers, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daptomycin in people with Meningitis, run by University of Pittsburgh 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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Aug 2013. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2013). 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?
Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis (time frame: 5 years). 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 12 Aug 2013.