NCT01875263

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2013

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

June 7, 2013

Last Update Submit

August 4, 2015

Conditions

Staphylococcus

Keywords

catheter-related bacteremia, SAMScatheter related bacteremiasusceptibleaureus meticillin

Outcome Measures

Primary Outcomes (1)

  • Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.

    18 months

Secondary Outcomes (2)

  • Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.

    18 months

  • Reduce the transesophagic echocardiography

    18 months

Study Arms (2)

Experimental

EXPERIMENTAL

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

Drug: CloxacilinDrug: Levofloxacin

Control

ACTIVE COMPARATOR

Cloxacillin 2g / 4 hrs iv 14 days

Drug: Cloxacillin

Interventions

CloxacilinDRUG

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

Experimental
CloxacillinDRUG

2g/4h 14 days Standard therapy

Control
LevofloxacinDRUG

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

Experimental

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Hospital de Jerez de la Frontera

Jerez de la Frontera, Cádiz, Spain

Location

Hospital Costa del Sol

Marbella, Málaga, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Complejo Hospitalario de Huelva

Huelva, Spain

Location

Hospital Can Misses

Ibiza Town, Spain

Location

Hospital Comarcal Carlos Haya

Málaga, Spain

Location

Hospital de Antequera

Málaga, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Virgen de Valme

Seville, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

MeSH Terms

Conditions

Short Stature, Auditory Canal Atresia, Mandibular Hypoplasia, Skeletal AbnormalitiesDisease Susceptibility

Interventions

CloxacillinLevofloxacin

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OxacillinPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2013

First Posted

June 11, 2013

Study Start

May 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

ES(11)