Cerebrospinal Fluid Pharmacokinetics of Daptomycin
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Meningitis |
Drug: Daptomycin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Cerebrospinal Fluid Pharmacokinetics of Daptomycin |
- Characterize the CSF and plasma concentration-time profile of daptomycin in patients with external ventricular drain (EVD) related meningitis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
-
Drug: Daptomycin
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Karin Byers, MD | 412-648-6401 | byersk@dom.pitt.edu |
| Contact: Diana Lynn Pakstis, RN, BSN | 412-648-6553 | dlp5@pitt.edu |
| United States, Pennsylvania | |
| UPMC | Not yet recruiting |
| PIttsburgh, Pennsylvania, United States, 15213 | |
| Contact: Karin Byers, MD 412-648-6401 byersk@dom.pitt.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 dlp5@pitt.edu | |
| Principal Investigator: Karin Byers, MD | |
| UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Karin Byers, MD 412-648-6429 byersk@dom.pitt.edu | |
| Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 dlp5@pitt.edu | |
| Principal Investigator: | Karin Byers, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Karin Byers, MD, UPMC |
| ClinicalTrials.gov Identifier: | NCT01025271 History of Changes |
| Other Study ID Numbers: | IRB#: PRO09070202 |
| Study First Received: | December 2, 2009 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
meningitis |
Additional relevant MeSH terms:
|
Meningitis Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Daptomycin |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013