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

Staphylococcus Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01875263
• Other study ID #: FPS-COL-2013-06
• Secondary ID: 2013-000511-24
• Status: Terminated
• Phase: Phase 3
• First received: June 7, 2013
• Last updated: August 4, 2015
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia
• Staphylococcus

Intervention

Drug:
• Cloxacilin
2g/4 hours i.v., 5 days
• Cloxacillin
2g/4h 14 days Standard therapy
• Levofloxacin
500 mg v.o./24h, 9 days

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Complejo Hospitalario de Huelva	Huelva
Spain	Hospital Can Misses	Ibiza
Spain	Hospital de Jerez de la Frontera	Jerez de la Frontera	Cádiz
Spain	Hospital Comarcal Carlos Haya	Málaga
Spain	Hospital de Antequera	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.		18 months	Yes
Secondary	Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.		18 months	Yes
Secondary	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	No