Catheter Related - Gram Positive Bloodstream Infections
This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
First received: April 26, 2007
Last updated: September 18, 2012
Last verified: September 2012
-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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections
Primary Outcome Measures:
- To find out if daptomycin can help to control CRIs with or without exchange of the central venous catheter (CVC) over a guide wire. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The safety of this treatment will also be studied. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
Daptomycin 6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria.
6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria.
Other Name: Cubicin
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years.
- The suspected culprit on exchangeable central venous catheter (CVC) is tunneled or non-tunnel (including ports and PICC) and antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular, peripheral or femoral vein.
- Patients must have at least two signs of sepsis from the list below, in any combination, within 48 hours prior to Daptomycin therapy and no other source for the bacteremia other than CVC: a. Core temperature =/>38.0 degrees C or =/<36.0 degrees C, measured orally, rectally, tympanic ally or via a central catheter. If auxiliary add 0.5 degrees C to the measured temperature; b. Pulse rate =/> 100 beats/min.; c. Respiratory rate =/> 20/min.; d. WBC count =/>12,000/mm^3 or =/<4,000/mm^3 differential count showing >10% band forms; e. Systolic blood pressure =/<90 mm Hg.
- Patients with probable or definite diagnosis of uncomplicated CVC-related gram positive bacteremia that includes at least one positive blood culture for CNS, SA, Enterococci, Corynebacterium, and Propionibacterium (If the positive blood culture is drawn through the CVC for skin flora such as CNS, Corynebacterium, Propionibacterium, Micrococcus and Bacillus, then at least >15 colonies/ml will be required or the time of positive (DTP) of CVC at least 2 hours earlier than the peripheral culture).
- Signed informed consent.
- No apparent source for the clinical manifestation of bacteremia other than the catheter (may have local signs and symptoms at the catheter site).
- Estimated Serum Creatinine Clearance <30 mL/min (according to Cock-Gault-formula)at the time gram positive bacteremia was diagnosed unless the patient is on dialysis.
- Bilirubin >4x the upper limit of normal at the time gram positive bacteremia was diagnosed.
- Treatment with an antibiotic, such as vancomycin, linezolid, tigecycline or daptomycin, effective against resistant gram positive bacterial infections, such as methicillin resistant staphylococci, for more than 48 hours within 72 hours of study medication initiation, unless treatment failed that is defined as a persistent fever, leukocytosis, and/or repeated positive blood cultures (CVC and peripheral) for 72 hours or longer of appropriate antibiotics treatment other than Daptomycin.
- Documented gram positive bacteremia within last 1 month due to source other than CVC.
- Patients who have participated in another investigational anti-infective study within 30 days.
- History of hypersensitivity to lipopeptides.
- Presence of additional source of infection with same organism cultured from blood, eg. endocarditis (as evidenced by vegetations on an echocardiogram), septic thrombosis.
- Conditions with markedly decreased albumin in plasma (<1.5 g/dl), e.g., cirrhosis, nephritic syndrome, end-stage renal disease.
- Prosthetic valve.
- Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.
- Possible complicated CRBSI with persistent bacteremia for more than 48 hours on active antimicrobial therapy (such as osteomyelitis, endocarditis, and septic thrombosis).
- Patients with diagnosis of pneumonia that is due to S. aureus organism, e.g, S. aureus from sputum or bronchial cultures.
- CPK >10X max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00467272
|UT MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center
||Issam Raad, MD
||M.D. Anderson Cancer Center
No publications provided
||M.D. Anderson Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 26, 2007
||September 18, 2012
||United States: Institutional Review Board
Keywords provided by M.D. Anderson Cancer Center:
Catheter-Related Bloodstream Infections
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 01, 2014