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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%) 
unable to meet enrollment no data available.
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