Primary Objective: -Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.
THE STUDY DRUG: Daptomycin is an antibiotic designed to treat a variety of bacterial infections that are difficult to treat. STUDY TREATMENT: If you are found to be eligible to take part in this study, you will be given daptomycin by vein over 30 minutes every 24 hours for at least 7-14 days, depending on the type of bacteria that you have. The central venous catheter (CVC) will either be removed, or it will be exchanged over a guide wire. The decision to remove or exchange the CVC and timing of the placement of the CVC will be decided by your primary physician and the willingness of you to remove or exchange your infected CVC. This will be done within 96 hours after your first positive blood culture (first blood drawn that showed bacteria). A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure. If the study doctor and/or your primary doctor suspects that you have a mixed infection (2 or more certain types of bacteria) or pneumonia, you will also be treated with different types of antibiotics, by vein or mouth, in combination with the study drug. These antibiotics may include aztreonam, cefepime, imipenem, meropenem, ciprofloxacin hydrochloride, bactrim, and/or amoxicillin/clavulanate (a combination antibiotic). If you are discharged from the hospital before completing the study medication, arrangements will be made to provide infusions on an outpatient basis (by a nurse, yourself, or a family member). You and/or a family member will be taught (by a nurse) how to take the study medication at home. Before you are discharged from the hospital, you will receive the kits that include enough supplies for you and/or a family member to give daptomycin by vein. If medication will be given at home, a prescription will be given to you to pick up your medication from the pharmacy before you discharge from the hospital. If possible, your primary doctor may arrange for you to receive medication at the M. D. Anderson outpatient treatment center, or a nurse will be scheduled to visit you at home to give you the medication. STUDY TESTS/PROCEDURES: During each week of treatment, you will have the following exams/procedures performed once a week. * You will have blood drawn (about 1 tablespoon) for routine tests. It may be drawn from the CVC, if the CVC is still in place. The CVC exit site will be examined at each visit until you have no more signs or symptoms of infection. * You will also have blood drawn (about 1 tablespoon) for a blood culture every other day until it no longer shows signs of infection. * You will be asked about any symptoms or illnesses that you may have experienced since your last visit. LENGTH OF STUDY: Participation on this study will last for no more than 60 days (about 2 months).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria. Treatment expected to be at least 14 days for SA and at least 7 days for enterococci and CNS, Corynebacterium, and Propionibacterium.
UT MD Anderson Cancer Center
Houston, Texas, United States
Clinical Response Within 48 Hours
Number of participants with clinical response within 48 hours from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 48 hours from initiating the study drug.
Time frame: Within 48 hours from initiating the study drug
Clinical Response Within 7 Days
Number of participants with clinical response within 1 week from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 7 days from initiating the study drug.
Time frame: Within 7 days from initiating the study drug
Microbiological Response Within 48 Hours
Number of participants with microbiological response within 48 hours from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).
Time frame: Within 48 hours from initiating the study drug
Microbiological Response Within 7 Days
Number of participants with microbiological response within 7 days from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).
Time frame: Within 7 days from initiating the study drug
Relapse
Number of participants with relapse was defined as the recurrence of bacteremia within the first 3 months.
Time frame: Within 3 months from initiating the study drug
Number of Participants With Overall Response
Overall response = symptom resolution within 3 days (since using antibiotic) + microbiological resolution within 3 days + no infection-related death + no infection-related late complications + no relapse. Infection-related late complication was defined as the development of deep-seated infection that was not present or suspected at the onset of bacteremia but was subsequently diagnosed after 1 week from initiation of study drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Within 3 days from initiating the study drug