A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00572260
• Collaborator: Cubist Pharmaceuticals LLC (Industry)
• Enrollment: 11
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision [30 days after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. barrier methods of birth control (e.g., condoms, diaphragms together with spermicidal foam or gel, or presence of IUD) or

5. 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.

1. If a female of childbearing potential, serum HCG negative within 24 hours of scheduled surgery.

2. Planned cardiac surgery procedures meeting current Duke criteria to receive anti-microbial prophylaxis active against MRSA:

1. 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

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• Cubist Pharmaceuticals LLC

Investigators

• Principal Investigator: Keith S Kaye, MD, MPH, DMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00572260
• Other Study ID Numbers: Pro00000856; 19497
• First Posted: Dec 13, 2007
• Last Update Posted: Jul 25, 2014
• Last Verified: Nov 1, 2012

• Keywords provided by Duke University: MRSA; Increased risk for infection
• Additional relevant MeSH terms: Daptomycin

Study Results

Participant Flow

Recruitment Details	Between 1/17/2008 and 9/15/2008, 124 subjects were identified as qualifying, 56 were referred and approached, 44 refused to participate, and 12 signed the ICF at Duke University Hospital inpatient care units.
Pre-assignment Detail	Between 1/17/2008 and 9/15/2008, among the 12 study subjects that signed the ICF, 11 subjects met the eligibility criteria and were enrolled in the study. One subject was disqualified due to weight > 150kg and was withdrawn from the study

Arm/Group Title	Antimicrobial Prophylaxis Administration With Daptomycin
Arm/Group Description
Period Title: Overall Study
STARTED	11
COMPLETED	11
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Antimicrobial Prophylaxis Administration With Daptomycin
Arm/Group Description
Overall Participants	11
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	5 45.5%
>=65 years	6 54.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (17)
Sex: Female, Male (Count of Participants)
Female	4 36.4%
Male	7 63.6%
Region of Enrollment (participants) [Number]
United States	11 100%

Outcome Measures

1. Primary Outcome

Title	Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision
Time Frame	30 days after surgery

Outcome Measure Data

Analysis Population Description

The study closed due to the departure of the principal investigator and the data analysis was not performed.

Arm/Group Title	Patients Undergoing Cardiac Surgery
Arm/Group Description	Patients undergoing cardiac valve replacement and coronary artery bypass grafting
Measure Participants	0

Adverse Events

Arm/Group Title	Antimicrobial Prophylaxis Administration With Daptomycin
Arm/Group Description
All Cause Mortality
	Antimicrobial Prophylaxis Administration With Daptomycin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Antimicrobial Prophylaxis Administration With Daptomycin
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Antimicrobial Prophylaxis Administration With Daptomycin
	Affected / at Risk (%)	# Events
Total	0/11 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.