Phase 2
N=41
Catheter Related - Gram Positive Bloodstream Infections
Bloodstream Infection
Bottom Line
View on ClinicalTrials.gov: NCT00467272 ↗Enrolled (actual)
41
Serious AEs
47.4%
Results posted
Feb 2021
Primary outcome: Primary: Clinical Response Within 48 Hours — 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Daptomycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response Within 48 Hours |
28 | — |
| PRIMARY Clinical Response Within 7 Days |
33 | — |
| PRIMARY Microbiological Response Within 48 Hours |
29 | — |
| PRIMARY Microbiological Response Within 7 Days |
34 | — |
| SECONDARY Relapse |
3 | — |
| SECONDARY Number of Participants With Overall Response |
25 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 =/ 100 beats/min.; c. Respiratory rate =/> 20/min.; d. white blood cell (WBC) count =/>12,000/mm^3 or =/ 10% band forms; e. Systolic blood pressure =/ 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).
Exclusion Criteria
- Estimated Serum Creatinine Clearance 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 ( 10 times max-normal in asymptomatic patients and CPK >5 max-normal in symptomatic patients.
Data sourced from ClinicalTrials.gov (NCT00467272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.