Methicillin resistant Staphylococcus aureus bacteremia, complicated or uncomplicated
Conditions
Interventions
Trade Name: FOSFOCINA
Product Name: FOSFOMICYN
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: FOSFOMYCIN
CAS Number: 23155-02-4
Concentration unit: g
Sponsors
Miquel Pujol Rojo (Infectious Diseases Service-Hospital Universitari de Bellvitge-IDIBELL)
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show a higher response at 6th week of end of therapy (EOT visit)on methicillin-resistant Staphylococcus aureus bacteremia when it's treated with a combination of Daptomycin plus Fosfomycin versus monotherapy with Daptomycin.;Secondary Objective: To compare clinical efficacy of Daptomycin plus Fosfomicyn versus Daptomycin monotherapy on patients with methicillin-resistant Staphylococcus aureus bacteremia at the end of therapy (TOC visit). To assess security of Daptomycin plus Fosfomycin versus Daptomycin monotherapy on patients with methicillin-resistant Staphylococcus aureus bacteremia. To assess overall mortality in both treatment groups during the study period. To asses frequency of persistant or recurrent bacteremia in both groups To determine emergency of Daptomycin or Fosfomycin resistence during therapy in both groups;Primary end point(s): Therapy response (defined as clinical and microbiological response);Timepoint(s) of evaluation of this end point: At 6 week post-therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Therapy response (defined as clinical and microbiological response) 2. Mortality 3. Severe adverse effects 4. Persistent bacteremia (defined as a positive blood culture at day 7) 5. Recurrent bacteremia (defined as a positive blood culture with a previous negative sample);Timepoint(s) of evaluation of this end point: 1. At end of therapy (it could be at week 2 or 4) 2. At the end of the study 3. At the end of the study 4. At the end of the study 5. At the end of the study | — |
Countries
Spain
Contacts
Public ContactHospital Universitario de Bellvitge
Miquel Pujol Rojo (Infectious diseases service)
Outcome results
None listed