Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.

• Status: Terminated
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the efficacy of a sequential regimen of 14 days in patients with catheter-related bacteremia by S. aureus methicillin-susceptible, selected based on a pre-established clinical and microbiological criteria.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud
• Treatments: Cloxacillin; Levofloxacin; Methicillin; Ofloxacin

Criteria

Inclusion Criteria:

• Patients ≥ 18 years with a minimum weight of 40 kg.

• Microbiological Isolation of S. aureus susceptible to meticillin.

• Start antibiotic treatment with drugs active against S. aureus within 72 hours from the onset of clinical manifestations.

• Women of childbearing potential, negative pregnancy test negative serum or urine or statement is not pregnant.

• Prescription prior treatment must be independent and decoupled patient inclusion in the study, corresponding exclusively to clinical practice.

Exclusion Criteria:

• Polymicrobial bacteremia.

• Neutropenic patients.

• Patients addicted to intravenous drugs.

• Patients with malignancies with expected survival less than 6 months.

• Severe allergy to beta-lactams or fluoroquinolones.

• Creatinine clearance <20ml/min.

• Need for hemodialysis, peritoneal dialysis or plasmapheresis.

• Clinical signs of deep infection in the first five days of treatment (mucocutaneous lesions suggestive of IE, embolic events, suppurative thrombophlebitis.

• Predictors of bacteremia complicated:

• Positive blood cultures for 48-96 hours of starting treatment antistaphylococcal

• Clinical Instability

• Signs of sepsis or persistent fever at day 4 of treatment

• Existence of valvular or vascular prosthetic joints, vascular catheter not removed within three days

• Heart disease predisposing to endocarditis.

• Patients presenting diagnosis concomitant infection by another organism.

• Pregnant or breast-feeding.

• Patients with epilepsy.

• Patients with a history of tendon disorders related to fluoroquinolone administration.

• Not have signed informed consent.