A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

Antimicrobial Prophylaxis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00572260
• Other study ID #: Pro00000856
• Secondary ID: 19497
• Status: Terminated
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: July 17, 2014
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Antimicrobial Prophylaxis

Intervention

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)

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Cubist Pharmaceuticals LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision		30 days after surgery	Yes