Clinical trial NCT01875263: Efficacy of a Short-term Sequential Therapy in Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
Official title: Efficacy of a Short-term Sequential Therapy Versus Intravenous Standard Treatment for Patients With Non-complicated Catheter Related Bacteremia by Methicillin- Susceptible S.Aureus.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Staphylococcus
Keywords: catheter-related bacteremia, SAMS
catheter related bacteremia
susceptible
aureus meticillin
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.
timeFrame: 18 months
Secondary outcomes:
measure: Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.
timeFrame: 18 months
measure: Reduce the transesophagic echocardiography
timeFrame: 18 months
Other outcomes:
Locations:
city: Jerez de la Frontera
country: Spain
facility: Hospital de Jerez de la Frontera
state: Cádiz
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Complejo Hospitalario de Huelva
city: Ibiza
country: Spain
facility: Hospital Can Misses
city: Málaga
country: Spain
facility: Hospital Comarcal Carlos Haya
city: Málaga
country: Spain
facility: Hospital de Antequera
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
References: