NCT00467272

Catheter Related - Gram Positive Bloodstream Infections

Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Bloodstream Infection

Interventions

Type	Name	Description
DRUG	Daptomycin	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.

Timeline

• Start date: 2007-03-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2007-04-30
• Last updated: 2021-02-08
• Results posted: 2021-02-08

Locations

1 site across 1 country: United States