Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus

NCT00507247 | Completed Phase 2 DMC

• 2 other identifiers: 2005-0622NCI-2010-00722
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Staphylococcus Aureus

Keywords

Catheter-Related Infection; Bloodstream Infections; Staphylococcus Aureus; Daptomycin

Outcome Measures

Primary Outcomes (1)

• Clinical Response Rate

  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.

  7 weeks

Study Arms (1)

Daptomycin

EXPERIMENTAL

6mg/kg/day intravenous (IV) for 10 days

Drug: Daptomycin

Interventions

Daptomycin DRUG

6mg/kg/day IV for at least 10 days.

Also known as: Cubicin

Daptomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 tunnel ( including implanted ports) or non-tunneled catheter, antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular 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, 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
• 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)
• Signed informed consent
• No apparent source for the clinical manifestation of bacteremia other than the catheter

You may not qualify if:

• Creatinine clearance \<30 mL/min 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 effective against Gram-positive bacterial infections for more than 48 hours within 72 hours of study medication initiation, unless treatment failed.
• Documented S. aureus bacteremia within last 3 months 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
• Anticipated prolonged therapy \>4 weeks
• Prosthetic endovascular material
• 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.)
• Evidence of catheter site purulence as evidenced by purulent discharge.
• Patients with diagnosis of pneumonia that is related to S. aureus organism
• Patients taking concomitant "statins" (HMG-CoA reductase inhibitors)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Staphylococcal Infections; Catheter-Related Infections; Sepsis

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Issam Raad, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2007
• First Posted: July 26, 2007
• Study Start: May 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: September 1, 2012
• Last Updated: July 20, 2016

Record last verified: 2014-11

Locations

US (1)