Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus

This study has been completed.
Sponsor:
Collaborator:
Cubist Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507247
First received: July 24, 2007
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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 CVC (central venous catheter) 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 Intervention Phase
Staphylococcus Aureus
Drug: Daptomycin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Clinical Response Rate [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
    Clinical response of Daptomycin administered for treatment of catheter-related bloodstream infections due to S. aureus bacteria, evaluated within 7 weeks of initiating Daptomycin therapy.


Enrollment: 11
Study Start Date: May 2006
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daptomycin
6mg/kg/day IV (by vein) for 10 days
Drug: Daptomycin
6mg/kg/day IV for at least 10 days.
Other Name: Cubicin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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) 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 >4x 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. CPK >10X max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507247

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cubist Pharmaceuticals
Investigators
Principal Investigator: Issam Raad, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507247     History of Changes
Other Study ID Numbers: 2005-0622
Study First Received: July 24, 2007
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014