EUCTR2013-000586-37-ES
Active, not recruiting
Not Applicable
Randomized multicenter study to assess efficacy of Daptomycin plus Fosfomycin versus Daptomycin monotherapy for treatment of methicillin resistant Staphylococcus aureus bacteremia in hospitalized patients.
Miquel Pujol Rojo (Infectious Diseases Service-Hospital Universitari de Bellvitge-IDIBELL)0 sitesMay 16, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Miquel Pujol Rojo (Infectious Diseases Service-Hospital Universitari de Bellvitge-IDIBELL)
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with at least 1 positive blood culture to meticillin\-resistant Staphylococcus aureus within the first 72h to the recruitment
- •2\. Adult patients, equal or older than 18 years
- •3\. Mandatory use of contraceptive for fertile women during the study period and the next 6 months to finalization
- •4\.Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 80
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 126
Exclusion Criteria
- •1\. Polymicrobial bacteremia
- •2\. Neumonia associated to bacteremia
- •3\. Severe clinical status with survival expectancy inferior to 24h.
- •4\. Liver function impairment (grade C Child\-Pugh)
- •5\. Allergy to Daptomycin or Fosfomycin.
- •6\. Positive pregnant test.
- •7\. The clinical status required an antibiotic with MRSA activity and do not allow to stop it during the study.
- •8\. Patient included in another clinical trial.
- •9\. Eosinophilic pneumonia history.
Outcomes
Primary Outcomes
Not specified
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