Catheter Related - Gram Positive Bloodstream Infections

NCT00467272 | Completed Phase 2 Results

• 1 other identifier: 2006-0958
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bloodstream Infection

Keywords

Catheter-Related Bloodstream Infections; Bloodstream Infection; Daptomycin; Cubicin; CRBSI

Outcome Measures

Primary Outcomes (4)

• Clinical Response Within 48 Hours

  Number of participants with clinical response within 48 hours from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 48 hours from initiating the study drug.

  Within 48 hours from initiating the study drug

• Clinical Response Within 7 Days

  Number of participants with clinical response within 1 week from initiation of Daptomycin, estimated by Bayesian posterior credible interval. Clinical response defined as resolution of clinical signs and symptoms within 7 days from initiating the study drug.

  Within 7 days from initiating the study drug

• Microbiological Response Within 48 Hours

  Number of participants with microbiological response within 48 hours from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).

  Within 48 hours from initiating the study drug

• Microbiological Response Within 7 Days

  Number of participants with microbiological response within 7 days from initiation of Daptomycin. Microbiological response defined as eradication of the microorganism from the bloodstream (negative blood cultures).

  Within 7 days from initiating the study drug

Secondary Outcomes (2)

• Relapse

  Within 3 months from initiating the study drug

• Number of Participants With Overall Response

  Within 3 days from initiating the study drug

Study Arms (1)

Daptomycin

EXPERIMENTAL

Daptomycin 6 mg/kg intravenous (IV) every 24 hours for at least 7-14 days, depending on the type of bacteria.

Drug: Daptomycin

Interventions

Daptomycin DRUG

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.

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 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).

You may not qualify if:

• 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.

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)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Sepsis

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Issam Raad, MD / Chair, Infectious Diseases
• Organization: University of Texas (UT) MD Anderson Cancer Center

iraad@mdanderson.org

713-792-7943

Study Officials

• Issam Raad, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 26, 2007
• First Posted: April 30, 2007
• Study Start: March 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 8, 2021
• Results First Posted: February 8, 2021

Record last verified: 2021-01

Locations

US (1)