Cerebrospinal Fluid Pharmacokinetics of Daptomycin

NCT01025271 | Terminated Results DMC

• 1 other identifier: IRB#: PRO09070202
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis

Keywords

meningitis

Outcome Measures

Primary Outcomes (1)

• 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

  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 (

  5 years

Study Arms (1)

open label

OTHER

patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin

Drug: Daptomycin

Interventions

Daptomycin DRUG

one dose of daptomycin (10 milligrams of the drug per kilogram of the subject's body weight

open label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Meningitis

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

unable to meet enrollment no data available.

Results Point of Contact

• Title: Karin Byers, MD
• Organization: University of Pittsburgh

dlp5@pitt.edu

412-648-6553

Study Officials

• Karin Byers, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 12, 2013
• Results First Posted: August 12, 2013

Record last verified: 2013-08

Locations

US (1)