A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

NCT00572260 | Terminated Phase 4 Results

• 2 other identifiers: Pro0000085619497
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

MRSA; Increased risk for infection

Outcome Measures

Primary Outcomes (1)

• Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision

  30 days after surgery

Study Arms (1)

A

EXPERIMENTAL

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

Interventions

daptomycin 6 mg/kg IV 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)

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Daptomycin

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Premature termination of the study due to departure of the PI resulted in falling short of enrollment goal (enrolled - 11 enrolled/goal - 100) leading to uninterpretable data.

Results Point of Contact

• Title: Yong Choi, Clinical Research Coordinator
• Organization: Duke University Health System

yong.choi@duke.edu

919-684-7584

Study Officials

• Keith S Kaye, MD, MPH

  DMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: July 25, 2014
• Results First Posted: December 3, 2012

Record last verified: 2012-11

Locations

US (1)