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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of a Short-term Sequential Therapy Versus Intravenous Standard Treatment for Patients With Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.

Conditions
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Staphylococcus

Intervention / Treatment
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* Drug: Cloxacilin
* Drug: Cloxacillin
* Drug: Levofloxacin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days. | Drug: Cloxacilin<br>* 2g/4 hours i.v., 5 days<br>Drug: Levofloxacin<br>* 500 mg v.o./24h, 9 days<br>|
| Active Comparator: Control<br>Cloxacillin 2g / 4 hrs iv 14 days | Drug: Cloxacillin<br>* 2g/4h 14 days Standard therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus. |  | 18 months | 
| Reduce the transesophagic echocardiography | Increase efficiency in the management of patients with bacteremia due to MS S. aureus, reducing the number of echocardiographic evidence | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter-related bacteremia, SAMS, catheter related bacteremia, susceptible, aureus meticillin