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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01875263

Enrollment

Registered

2013-06-11

Start date

2013-05-31

Completion date

2014-11-30

Last updated

2015-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Staphylococcus

Keywords

catheter-related bacteremia, SAMS, catheter related bacteremia, susceptible, aureus meticillin

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.

Interventions

DRUGLevofloxacin

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

DRUGCloxacilin

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

DRUGCloxacillin

2g/4h 14 days Standard therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026