Status:
TERMINATED
Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
Lead Sponsor:
Fundación Pública Andaluza Progreso y Salud
Conditions:
Staphylococcus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 microbiolog...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01875263
Start Date
May 1 2013
End Date
November 1 2014
Last Update
August 7 2015
Active Locations (11)
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1
Hospital de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
2
Hospital Costa del Sol
Marbella, Málaga, Spain
3
Hospital Universitario Reina Sofía
Córdoba, Spain
4
Hospital Universitario Virgen de las Nieves
Granada, Spain