Trial Outcomes & Findings for A Pilot Study of Daptomycin for Antimicrobial Prophylaxis (NCT NCT00572260)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

30 days after surgery

Results posted on

2014-07-25

Participant Flow

Between 1/17/2008 and 9/15/2008, 124 subjects were identified as qualifying, 56 were referred and approached, 44 refused to participate, and 12 signed the ICF at Duke University Hospital inpatient care units.

Between 1/17/2008 and 9/15/2008, among the 12 study subjects that signed the ICF, 11 subjects met the eligibility criteria and were enrolled in the study. One subject was disqualified due to weight \> 150kg and was withdrawn from the study

Participant milestones

Participant milestones
Measure	Antimicrobial Prophylaxis Administration With Daptomycin
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antimicrobial Prophylaxis Administration With Daptomycin n=11 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 17 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after surgery

Population: The study closed due to the departure of the principal investigator and the data analysis was not performed.

Outcome measures

Outcome data not reported

Adverse Events

Antimicrobial Prophylaxis Administration With Daptomycin

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

Yong Choi, Clinical Research Coordinator

Duke University Health System

Phone: 919-684-7584

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place