Phase IV-III Clinical Trial, randomized, controlled, open and multicentric, with parallel groups, to evaluate the efficacy of Cloxacillin and fosfomycin combination versus Cloxacillin monotherapy in the treatment of methicillin-susceptible Staphylococcus aureus bacteraemia.

Phase 1

• Conditions: Methicilin-susceptible S.aureus bacteraemia.; MedDRA version: 20.0 Level: LLT Classification code 10058863 Term: Staphylococcus aureus bacteraemia System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2018-001207-37-ES
• Lead Sponsor: Miquel Pujol i Rojo ( Servicio de Enfermedades Infecciosas del Hospital Universitari de Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 366

Inclusion Criteria

1) 18 years of age or over.
2) Patients hospitalised with 1 or more MSSA-positive blood cultures obtained within the 72 hours prior to inclusion in the study, in a context suggesting an infection.
3) The subject or their legal representative grants 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 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1) Compromised clinical situation with a life expectancy of = 24 h.
2) Resistance to fosfomycin.
3) Severely impaired liver function (Child-Pugh grade C).
4) NYHA scale III-IV heart failure.
5) Need for concomitant antibiotic therapy together with the study antibiotics for the first 7 days of the study, active against S. aureus.
6) Hypersensitivity to cloxacillin or to beta-lactams in general or to fosfomycin.
7) Polymicrobial bacteremia.
8) Participation in another clinical therapy trial.
9) Previous participation in the present clinical trial.
10) Myasthenia gravis
11) Pregnancy and lactation

Study & Design

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