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

Primary Purpose

Staphylococcus

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Cloxacilin
Cloxacillin
Levofloxacin
Sponsored by
Fundación Pública Andaluza Progreso y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcus focused on measuring catheter-related bacteremia, SAMS, catheter related bacteremia, susceptible, aureus meticillin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital de Jerez de la Frontera
  • Hospital Costa del Sol
  • Hospital Universitario Reina Sofía
  • Hospital Universitario Virgen de las Nieves
  • Complejo Hospitalario de Huelva
  • Hospital Can Misses
  • Hospital Comarcal Carlos Haya
  • Hospital de Antequera
  • Hospital Universitario Virgen de la Victoria
  • Hospital Universitario Virgen de Valme
  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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

Cloxacillin 2g / 4 hrs iv 14 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.
Reduce the transesophagic echocardiography
Increase efficiency in the management of patients with bacteremia due to MS S. aureus, reducing the number of echocardiographic evidence

Full Information

First Posted
June 7, 2013
Last Updated
August 4, 2015
Sponsor
Fundación Pública Andaluza Progreso y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT01875263
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Not participants inclusion
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza Progreso y Salud

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus
Keywords
catheter-related bacteremia, SAMS, catheter related bacteremia, susceptible, aureus meticillin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Cloxacillin 2g / 4 hrs iv 14 days
Intervention Type
Drug
Intervention Name(s)
Cloxacilin
Intervention Description
2g/4 hours i.v., 5 days
Intervention Type
Drug
Intervention Name(s)
Cloxacillin
Intervention Description
2g/4h 14 days Standard therapy
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
500 mg v.o./24h, 9 days
Primary Outcome Measure Information:
Title
Reduce the rate of late complications of catheter-related bacteremia by S. aureus methicillin sensitive below 2%.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Reducing hospital stay associated with the treatment of uncomplicated bacteremia MS S. aureus.
Time Frame
18 months
Title
Reduce the transesophagic echocardiography
Description
Increase efficiency in the management of patients with bacteremia due to MS S. aureus, reducing the number of echocardiographic evidence
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital de Jerez de la Frontera
City
Jerez de la Frontera
State/Province
Cádiz
Country
Spain
Facility Name
Hospital Costa del Sol
City
Marbella
State/Province
Málaga
Country
Spain
Facility Name
Hospital Universitario Reina Sofía
City
Córdoba
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
Complejo Hospitalario de Huelva
City
Huelva
Country
Spain
Facility Name
Hospital Can Misses
City
Ibiza
Country
Spain
Facility Name
Hospital Comarcal Carlos Haya
City
Málaga
Country
Spain
Facility Name
Hospital de Antequera
City
Málaga
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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