A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

This study has been terminated.
(Study closed. PI left the institution.)
Sponsor:
Collaborator:
Cubist Pharmaceuticals
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00572260
First received: December 12, 2007
Last updated: July 17, 2014
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Antimicrobial Prophylaxis
Drug: daptomycin 6 mg/kg IV
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pilot Study of Daptomycin for Antimicrobial Prophylaxis in Patients Undergoing Cardiac Valve Replacement and Coronary Artery Bypass Grafting (CABG) Who Are at Increased Risk for Infection Due to Methicillin-resistant Staphylococcus Aureus (MRSA)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: January 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Daptomycin as a single preoperative dose within 30 minutes prior to surgery Dosage: if creatinine clearance ≥ 30 ml/min: 6 mg/kg IV
Drug: daptomycin 6 mg/kg IV
daptomycin 6 mg/kg IV given during induction phase as a one-time prophylactic dose for patients undergoing cardiac valve replacement and coronary artery bypass grafting (CABG) who are at increased risk for infection due to methicillin-resistant Staphylococcus aureus (MRSA)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA: Patients will be eligible for inclusion in the study if they meet the following criteria:

  1. Provide signed and dated informed consent and are willing to receive the study medication
  2. Age ≥ 18 years of age
  3. If a female of childbearing potential is willing to practice at least one method of birth control during treatment and for at least 28 days after treatment with study medication:

    1. barrier methods of birth control (e.g., condoms, diaphragms together with spermicidal foam or gel, or presence of IUD) or
    2. surgical sterilization, approved hormonal contraceptives (such as birth control pills, depo-Provera, or Lupron Depot), or IUD are all acceptable.

      • Rhythm, temperature, and verbal promise of abstinence are not acceptable methods of birth control.
  4. If a female of childbearing potential, serum HCG negative within 24 hours of scheduled surgery.
  5. Planned cardiac surgery procedures meeting current Duke criteria to receive anti-microbial prophylaxis active against MRSA:

    a. Patients will meet at least one of the following criteria which are the same as for prophylaxis with vancomycin: i. preoperative hospitalization > 48 hours ii. transfer to Duke from outside facility iii. previous history of MRSA iv. any patient deemed to be high risk for MRSA by the attending surgeon, due to a complicated past medical and/or surgical history

EXCLUSION CRITERIA: Patients who satisfy any of the following are not eligible for study enrollment.

  1. Hypersensitivity to daptomycin
  2. Inability to receive standard prophylaxis agents (cefuroxime and rifampin) for any reason
  3. Staphylococcal bacteremia at the time of enrollment
  4. Diagnosis of S. aureus or coagulase negative staphylococcus pacemaker/defibrillator infection within the preceding 18 months
  5. Patient is undergoing emergency CABG
  6. Weight >150 kg or <50kg
  7. Patients considered unlikely to survive at least 7 days due to underlying illness.
  8. Patients with creatinine clearance (CLcr) < 30mL/min (calculated using the Cockcroft-Gault equation using actual body weight)
  9. Severe neutropenia (absolute neutrophil count <0.500x103 /µL)
  10. Pregnant, nursing or lactating women (if patient is still of childbearing potential, a negative serum pregnancy test will be confirmed)
  11. Patients considered unlikely to comply with study procedures or to return for the scheduled post treatment evaluation
  12. Any other condition that in the opinion of an investigator, would confound or interfere with evaluation of safety or efficacy of the investigational medication, or prevent compliance with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572260

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Cubist Pharmaceuticals
Investigators
Principal Investigator: Keith S Kaye, MD, MPH DMC
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00572260     History of Changes
Other Study ID Numbers: Pro00000856, 19497
Study First Received: December 12, 2007
Results First Received: March 29, 2011
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
MRSA
Increased risk for infection

Additional relevant MeSH terms:
Anti-Infective Agents
Daptomycin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 27, 2014