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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-11-30

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.

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Detailed Description

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Conditions

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Staphylococcus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

Cloxacilin

Intervention Type DRUG

2g/4 hours i.v., 5 days

Levofloxacin

Intervention Type DRUG

500 mg v.o./24h, 9 days

Control

Cloxacillin 2g / 4 hrs iv 14 days

Group Type ACTIVE_COMPARATOR

Cloxacillin

Intervention Type DRUG

2g/4h 14 days Standard therapy

Interventions

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Cloxacilin

2g/4 hours i.v., 5 days

Intervention Type DRUG

Cloxacillin

2g/4h 14 days Standard therapy

Intervention Type DRUG

Levofloxacin

500 mg v.o./24h, 9 days

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No