Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

NCT00701636 | Completed Phase 3 Results DMC

• 2 other identifiers: 12903-01IIS 0003-07-2007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.

Conditions

Late Effects of Surgery; Staphylococcus Aureus; Surgical Site Infection

Keywords

Daptomycin; Antibiotic Prophylaxis; Pharmacokinetics; Surgical Wound Infection; Staphylococcus aureus; Cardiopulmonary Bypass Surgery

Outcome Measures

Primary Outcomes (1)

• Mean Daptomycin Concentrations at 12, 18, 24, and 48 h

  Mean daptomycin concentrations (mcg/ml) at 12, 18, 24, and 48 h

  Hospital discharge or 7 days, whichever comes first

Study Arms (2)

Cases

EXPERIMENTAL

The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical antibiotic prophylaxis.

Drug: daptomycin

Controls

NO INTERVENTION

15 subjects will be enrolled in the standard of care antibiotic group to serve as the controls. Controls will receive no experimental medications or treatments. The purpose of enrolling control patients was to serve as a reference group for intervention patients. Specifically cases and controls will be compared for changes in commonly collected hematologic parameters, creatinine, and CPK. Additionally, parameters collected during anesthesia will be compared. Controls will be matched to the intervention group by age (+/- 10 years), gender, and ethnicity.

Interventions

daptomycin DRUG

Subjects enrolled in the intervention group will receive a single intravenous administration of daptomycin 8 mg/kg 30-60 minutes prior to surgery (incision). The 500 mg vial will be reconstituted with 10 mL of 0.9% normal saline (NS) and further diluted in 50 mL of 0.9% NS to be given over a 30 minute infusion.

Also known as: Cubicin

Cases

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patients, awaiting scheduled elective coronary artery bypass graft (CABG) surgery without valve replacement surgery
• Age \> 18 years and \< 75 years
• BMI between 18.5 and 35.0 kg/meters-squared
• Crcl \> 50 ml/minute calculated based on Cockcroft Gault equation
• No known active or suspected infection(s)
• Ability to complete the informed consent process
• Negative pregnancy test (for women of childbearing age)

You may not qualify if:

• History of allergic reaction to daptomycin or components of daptomycin
• Receipt of daptomycin within 7 days prior to the surgery
• Elevated CPK levels (defined as \> 3 times the upper limits of known normal)
• History of myopathy or complaints consistent with myopathy
• Current or planned use of mycophenolate mofetil, mycophenolic acid, or tobramycin during the subjects' current hospitalization (all of which are known to interact with daptomycin)
• Inability to complete the informed consent process because of problems with mental capacity
• Pregnancy and/or breast feeding

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator
• Hartford Hospital: collaborator
• Western University of Health Sciences: collaborator

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Related Publications (1)

• Nguyen MH, Eells SJ, Tan J, Sheth CT, Omari B, Flores M, Wang J, Miller LG. Prospective, open-label investigation of the pharmacokinetics of daptomycin during cardiopulmonary bypass surgery. Antimicrob Agents Chemother. 2011 Jun;55(6):2499-505. doi: 10.1128/AAC.01404-10. Epub 2011 Mar 28.

  PMID: 21444695 RESULT

Related Links

• Free full text article

MeSH Terms

Conditions

Staphylococcal Infections; Surgical Wound Infection

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Loren Miller MD
• Organization: LA BioMed at Harbor-UCLA Medical Center

Lgmiller@ucla.edu

310-222-3813

Study Officials

• Loren G Miller, M.D., M.P.H.

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 29, 2016
• Results First Posted: August 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)