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

F

Fundación Pública Andaluza Progreso y Salud

Status and phase

Terminated
Phase 3

Conditions

Staphylococcus

Treatments

Drug: Cloxacilin
Drug: Levofloxacin
Drug: Cloxacillin

Study type

Interventional

Funder types

Other

Identifiers

NCT01875263
2013-000511-24 (EudraCT Number)
FPS-COL-2013-06

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1 participants in 2 patient groups

Experimental
Experimental group
Description:
Cloxacillin 2g / 4 hours iv, 5 days followed levofloxacin 500 mg po / 24, 9 days.
Treatment:
Drug: Levofloxacin
Drug: Cloxacilin
Control
Active Comparator group
Description:
Cloxacillin 2g / 4 hrs iv 14 days
Treatment:
Drug: Cloxacillin

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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