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.

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.

Study Overview

• Status: Terminated
• Conditions: Staphylococcus
• Intervention / Treatment: Drug: Cloxacilin; Drug: Levofloxacin; Drug: Cloxacillin

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza Progreso y Salud

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: June 7, 2013
• First Submitted That Met QC Criteria: June 10, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: catheter-related bacteremia, SAMS; catheter related bacteremia; susceptible; aureus meticillin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin; Cloxacillin
• Other Study ID Numbers: FPS-COL-2013-06; 2013-000511-24 (EudraCT Number)