Catheter Related - Gram Positive Bloodstream Infections
Condition: Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis
Intervention: Daptomycin
Intervention description: 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.
Intervention MeSH terms: Daptomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Catheter-Related Bloodstream Infections; Bloodstream Infection; Daptomycin; Cubicin; CRBSI

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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. white blood cell (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 Coagulase
             Negative Staphylococci (CNS), Staphylococcus aureus (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).

        Exclusion Criteria:

          -  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 >4 times 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.

          -  creatine phosphokinase (CPK) >10 times max-normal in asymptomatic patients and CPK >5
             max-normal in symptomatic patients.