Randomized multicenter study to compare survival and clinical improvement of methicillin resistant Staphylococcus aureus bacteremia in hospitalized patients when they are treated with combination of Daptomycin plus Fosfomycin versus Daptomycin alone.

• Conditions: Methicillin resistant Staphylococcus aureus bacteremia, complicated or uncomplicated; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-000586-37-ES
• Lead Sponsor: Miquel Pujol Rojo (Infectious Diseases Service-Hospital Universitari de Bellvitge-IDIBELL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-16
• Last Update Posted: 7 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified