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Cerebrospinal Fluid Pharmacokinetics of Daptomycin

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ClinicalTrials.gov Identifier: NCT01025271
Recruitment Status : Terminated (unable to enroll subjects study stopped due to lack of enrollment)
First Posted : December 3, 2009
Results First Posted : August 12, 2013
Last Update Posted : August 12, 2013
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE December 2, 2009
First Posted Date  ICMJE December 3, 2009
Results First Submitted Date  ICMJE August 23, 2012
Results First Posted Date  ICMJE August 12, 2013
Last Update Posted Date August 12, 2013
Study Start Date  ICMJE May 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
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 ]
no analysis completed
Original Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cerebrospinal Fluid Pharmacokinetics of Daptomycin
Official Title  ICMJE Cerebrospinal Fluid Pharmacokinetics of Daptomycin
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Meningitis
Intervention  ICMJE Drug: Daptomycin
one dose of daptomycin (10 milligrams of the drug per kilogram of the subject's body weight
Study Arms  ICMJE open label
patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Intervention: Drug: Daptomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 8, 2013)
2
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)
20
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01025271
Other Study ID Numbers  ICMJE IRB#: PRO09070202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Cubist Pharmaceuticals LLC
Investigators  ICMJE
Principal Investigator: Karin Byers, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP