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Study Summary
No. 2006-0958:.......Infection......Issam Raad......Infection Control/Infectious Diseases & Employee Health
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Study Summary Title
Study Summary
Number:
2006-0958
Study Title:Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections
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Physician New Patient Referral
Name:Issam RaadPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Infection Control/Infectious Diseases & Employee HealthReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7943
Contact us about clinical trials
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General Information
Disease Group:InfectionSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
End of Treatment (EOT) within 7 days after the last dose of study drug.

Post-treatment (32 +/- 7 days after the last dose of study drug).
Treatment
Agents:
DaptomycinHome Care:Study drug can be given at home if possible.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
The duration of study drug therapy will be at least 7 days. The study drug can
be administered in both inpatient and outpatient basis and/or self
administration at home if possible.
Description/
Intervention:
The goal of this clinical research study is to find out if daptomycin can help
to control CRIs with or without exchange of the central venous catheter (CVC)
over a guide wire. The safety of this treatment will also be studied.
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Study Objectives / Outcomes
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.
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Study Status Information
Study Activation / Registration Date:03/27/2007
IRB Review and Approval Date:03/27/2007
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Closed
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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 tunneled or non-tunnel (including ports and PICC) and antibiotic or non-antibiotic coated catheter inserted in the subclavian, jugular, peripheral 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, 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. 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 probable or definite diagnosis of uncomplicated CVC-related gram positive bacteremia that includes at least one positive blood culture for CNS, 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).

5) Signed informed consent.

6) 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:1) 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.

2) Bilirubin >4x the upper limit of normal at the time gram positive bacteremia was diagnosed.

3) Treatment with an antibiotic, such as vancomycin, linezolid, tigercycline 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.

4) Documented gram positive bacteremia within last 1 month 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) Prosthetic valve.

10) Oliguria defined as urine output of <20 cc/hour averaged over 24 hours.

11) Possible complicated CRBSI with persistent bacteremia for more than 48 hours on active antimicrobial therapy (such as osteomyelitis, endocarditits, and septic thrombosis).

12) Patients with diagnosis of pneumonia that is due to S. aureus organism, e.g, S .aureus from sputum or bronchial cultures.

13) CPK >10X max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.

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Links
Registration Number: NCT00467272
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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