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Trial Outcomes & Findings for Cerebrospinal Fluid Pharmacokinetics of Daptomycin (NCT NCT01025271)

NCT ID: NCT01025271

Last Updated: 2013-08-12

Results Overview

unable to meet enrollment no data available. Study terminated early

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

5 years

Results posted on

2013-08-12

Participant Flow

unable to meet enrollment no data available. Study terminated early

unable to meet enrollment no data available. Study terminated early

Participant milestones

Participant milestones
Measure
Open Label
patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Overall Study
STARTED
2
Overall Study
COMPLETED
2
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cerebrospinal Fluid Pharmacokinetics of Daptomycin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Open Label
n=2 Participants
patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Sex: Female, Male
Female
1 Participants
n=5 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: unable to meet enrollment no data available. Study terminated early

unable to meet enrollment no data available. Study terminated early

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

no analysis completed

Outcome measures

Outcome data not reported

Adverse Events

Open Label

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karin Byers, MD

University of Pittsburgh

Phone: 412-648-6553

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place