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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 Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Meningitis
Intervention Drug: Daptomycin
Enrollment 2
Recruitment Details unable to meet enrollment no data available. Study terminated early
Pre-assignment Details unable to meet enrollment no data available. Study terminated early
Arm/Group Title Open Label
Hide Arm/Group Description patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Period Title: Overall Study
Started 2 [1]
Completed 2 [1]
Not Completed 0
[1]
unable to meet enrollment no data available. Study terminated early
Arm/Group Title Open Label
Hide Arm/Group Description patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Characterize the CSF and Plasma Concentration-time Profile of Daptomycin in Patients With External Ventricular Drain (EVD) Related Meningitis
Hide Description unable to meet enrollment no data available. Study terminated early
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
unable to meet enrollment no data available. Study terminated early
Arm/Group Title Open Label
Hide Arm/Group Description:
patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title 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 (
Hide Description no analysis completed
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PK Sampling
Hide Arm/Group Description:
patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label
Hide Arm/Group Description patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
All-Cause Mortality
Open Label
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Open Label
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Label
Affected / at Risk (%)
Total   0/2 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Karin Byers, MD
Organization: University of Pittsburgh
Phone: 412-648-6553
EMail: dlp5@pitt.edu
Layout table for additonal information
Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01025271    
Other Study ID Numbers: IRB#: PRO09070202
First Submitted: December 2, 2009
First Posted: December 3, 2009
Results First Submitted: August 23, 2012
Results First Posted: August 12, 2013
Last Update Posted: August 12, 2013