Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00507247
Recruitment Status : Completed
First Posted : July 26, 2007
Last Update Posted : July 20, 2016
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Primary Objective:

Evaluate the efficacy and safety of daptomycin given for treatment of catheter-related bloodstream infections due to S. aureus bacteria with or without exchange of the central venous catheter (CVC) over guide wire in comparison with a historical control group of catheter-related S. aureus bacteremia treated with standard therapy (Vancomycin) or other active agents against staph aureus (such as beta-lactam antibiotics).

Condition or disease Intervention/treatment Phase
Staphylococcus Aureus Drug: Daptomycin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus Bloodstream Infections
Study Start Date : May 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Daptomycin
6mg/kg/day intravenous (IV) for 10 days
Drug: Daptomycin
6mg/kg/day IV for at least 10 days.
Other Name: Cubicin

Primary Outcome Measures :
  1. Clinical Response Rate [ Time Frame: 7 weeks ]
    Clinical response of Daptomycin administered for treatment of catheter-related bloodstream infections due to Staphylococcus Aureus bacteria, evaluated within 7 weeks of initiating Daptomycin therapy.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years.
  2. The suspected culprit on exchangeable central venous catheter (CVC) is tunnel ( including implanted ports) or non-tunneled catheter, antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular or femoral vein.
  3. 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, tympanically or via a central catheter. If axillary add 0.5 degrees C to the measured temperature; (b) Pulse rate =/> 100 beats/min.; (c) Respiratory rate =/> 20/min; (d) white blood count (WBC) count =/>12,000/mm^3 or =/<4,000/mm^3 differential count showing >10% band forms; (e) Systolic blood pressure=/ <90 mm Hg
  4. Patients with suspected or definite diagnosis of uncomplicated CVC-related gram-positive bacteremia that includes at least one positive blood culture for S aureus. (If the positive blood culture is drawn through the CVC, then at least >15 colonies/ml will be required or the differential time of positive (DTP) of CVC at least 2 hours earlier than the peripheral culture)
  5. Signed informed consent
  6. No apparent source for the clinical manifestation of bacteremia other than the catheter

Exclusion Criteria:

  1. Creatinine clearance <30 mL/min at the time gram positive bacteremia was diagnosed unless the patient is on dialysis
  2. Bilirubin >4 times the upper limit of normal at the time gram positive bacteremia was diagnosed
  3. Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 48 hours within 72 hours of study medication initiation, unless treatment failed.
  4. Documented S. aureus bacteremia within last 3 months due to source other than CVC.
  5. Patients who have participated in another investigational anti-infective study within 30 days
  6. History of hypersensitivity to lipopeptides
  7. Presence of additional source of infection with same organism cultured from blood, eg. endocarditis (as evidenced by vegetations on an echocardiogram), septic thrombosis
  8. Conditions with markedly decreased albumin in plasma (<1.5 g/dl), e.g., cirrhosis, nephritic syndrome, end-stage renal disease
  9. Anticipated prolonged therapy >4 weeks
  10. Prosthetic endovascular material
  11. Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.
  12. Possible complicated CRBSI with persistent bacteremia for more than 48 hours on active antimicrobial therapy (such as osteomyelitis, endocarditis, and septic thrombosis.)
  13. Evidence of catheter site purulence as evidenced by purulent discharge.
  14. Patients with diagnosis of pneumonia that is related to S. aureus organism
  15. Patients taking concomitant "statins" (HMG-CoA reductase inhibitors)
  16. creatine phosphokinase (CPK) >10 times max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00507247

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cubist Pharmaceuticals LLC
Principal Investigator: Issam Raad, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00507247     History of Changes
Other Study ID Numbers: 2005-0622
NCI-2010-00722 ( Registry Identifier: NCI CTRP )
First Posted: July 26, 2007    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: November 2014

Keywords provided by M.D. Anderson Cancer Center:
Catheter-Related Infection
Bloodstream Infections
Staphylococcus Aureus

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents