A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

Study Overview
=================
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.

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)

Conditions
-----------------
Antimicrobial Prophylaxis

Intervention / Treatment
-----------------
* Drug: daptomycin 6 mg/kg IV


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients will be eligible for inclusion in the study if they meet the following criteria: Provide signed and dated informed consent and are willing to receive the study medication Age ≥ 18 years of age 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: barrier methods of birth control (e.g., condoms, diaphragms together with spermicidal foam or gel, or presence of IUD) or 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. If a female of childbearing potential, serum HCG negative within 24 hours of scheduled surgery. 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. Hypersensitivity to daptomycin Inability to receive standard prophylaxis agents (cefuroxime and rifampin) for any reason Staphylococcal bacteremia at the time of enrollment Diagnosis of S. aureus or coagulase negative staphylococcus pacemaker/defibrillator infection within the preceding 18 months Patient is undergoing emergency CABG Weight >150 kg or <50kg Patients considered unlikely to survive at least 7 days due to underlying illness. Patients with creatinine clearance (CLcr) < 30mL/min (calculated using the Cockcroft-Gault equation using actual body weight) Severe neutropenia (absolute neutrophil count <0.500x103 /µL) Pregnant, nursing or lactating women (if patient is still of childbearing potential, a negative serum pregnancy test will be confirmed) Patients considered unlikely to comply with study procedures or to return for the scheduled post treatment evaluation 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision |  | 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRSA, Increased risk for infection