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

Fundación Pública Andaluza Progreso y Salud

Status and phase: Terminated; Phase 3

Conditions: Staphylococcus

Treatments: Drug: Cloxacillin; Drug: Cloxacilin; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT01875263

2013-000511-24 (EudraCT Number)

FPS-COL-2013-06

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Experimental

Experimental group

Description:

Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days.

Treatment:

Drug: Cloxacilin

Drug: Levofloxacin

Control

Active Comparator group

Description:

Cloxacillin 2g / 4 hrs iv 14 days

Treatment:

Drug: Cloxacillin