View Clinical Trial (Medical Research Study)
Cerebrospinal Fluid Pharmacokinetics of Daptomycin
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Meningitis |
| Purpose: |
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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.
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| Study Summary: |
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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
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| Criteria: |
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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
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| NCT ID: |
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NCT01025271 |
| Primary Contact: |
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Principal Investigator
Karin Byers, MD
University of Pittsburgh
Karin Byers, MD
Phone: 412-648-6401
Email: byersk@dom.pitt.edu
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| Backup Contact: |
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Email: dlp5@pitt.edu
Diana Lynn Pakstis, RN, BSN
Phone: 412-648-6553
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| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Karin Byers, MD
Phone: 412-648-6429
Email: byersk@dom.pitt.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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