Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
- Conditions
- Staphylococcus
- Interventions
- Registration Number
- NCT01875263
- Lead Sponsor
- Fundación Pública Andaluza Progreso y Salud
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Cloxacilin Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days. Experimental Levofloxacin Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days. Control Cloxacillin Cloxacillin 2g / 4 hrs iv 14 days
- Primary Outcome Measures
Name Time Method Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%. 18 months
- Secondary Outcome Measures
Name Time Method Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus. 18 months Reduce the transesophagic echocardiography 18 months Increase efficiency in the management of patients with bacteremia due to MS S. aureus, reducing the number of echocardiographic evidence
Trial Locations
- Locations (11)
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain
Hospital de Antequera
🇪🇸Málaga, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Costa del Sol
🇪🇸Marbella, Málaga, Spain
Hospital de Jerez de la Frontera
🇪🇸Jerez de la Frontera, Cádiz, Spain
Hospital Can Misses
🇪🇸Ibiza, Spain
Complejo Hospitalario de Huelva
🇪🇸Huelva, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Universitario Virgen de Valme
🇪🇸Sevilla, Spain
Hospital Comarcal Carlos Haya
🇪🇸Málaga, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain