A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

NCT ID: NCT00572260

Last Updated: 2014-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-09-30

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.

Conditions

Antimicrobial Prophylaxis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: EXPERIMENTAL

daptomycin 6 mg/kg IV

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith S Kaye, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

DMC

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

19497

Identifier Type: -

Identifier Source: secondary_id

Pro00000856

Identifier Type: -

Identifier Source: org_study_id