A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

Phase 4

Terminated

• Conditions: Antimicrobial Prophylaxis
• Interventions: Drug: daptomycin 6 mg/kg IV

• Registration Number: NCT00572260
• Lead Sponsor: Duke University

Brief Summary

The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Study Start: 2008-01
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2011-03-29
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-05
• Results First Posted: 2012-12-03
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	daptomycin 6 mg/kg IV	Daptomycin as a single preoperative dose within 30 minutes prior to surgery Dosage: if creatinine clearance ≥ 30 ml/min: 6 mg/kg IV

Primary Outcome Measures

Name	Time	Method
Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision	30 days after surgery

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States