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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Meningitis Drug: Daptomycin Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cerebrospinal Fluid Pharmacokinetics of Daptomycin
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Daptomycin

Arms and Interventions
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Arm Intervention/treatment
open label
patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
 Drug: Daptomycin
one dose of daptomycin (10 milligrams of the drug per kilogram of the subject's body weight


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 ( [ Time Frame: 5 years ]
    no analysis completed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025271


Locations
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United States, Pennsylvania
UPMC
PIttsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Cubist Pharmaceuticals LLC
Investigators
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Principal Investigator: Karin Byers, MD University of Pittsburgh
More Information
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Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01025271    
Other Study ID Numbers: IRB#: PRO09070202
First Posted: December 3, 2009    Key Record Dates
Results First Posted: August 12, 2013
Last Update Posted: August 12, 2013
Last Verified: August 2013
Keywords provided by University of Pittsburgh:
meningitis
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
 Gram-Negative Bacterial Infections
Bacterial Infections
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents