Status:

TERMINATED

Prolonging the Duration of Peripheral Venous Catheters in Cystic Fibrosis People

Lead Sponsor:

University of Florence

Collaborating Sponsors:

Italian Cystic Fibrosis Research Foundation

Ospedale Meyer

Conditions:

Cystic Fibrosis

Phlebitis

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Patients with cystic fibrosis (CF) need to frequently undergo courses of IV antibiotic therapy. To avoid a high number of venipunctures peripheral venous catheters (SPVC) or cannulas are used. Because...

Detailed Description

Background Cystic Fibrosis (CF) is a common genetic disease which affects, among other organs, the respiratory tree. The major cause of mortality and morbidity in CF are pulmonary infections caused b...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Diagnosis of cystic fibrosis, made accordingly to the Cystic Fibrosis Foundation Guideline (Rosenstein BJ. J Pediatr 1998;132: 589-595)
  • age of 18 years or more and ability to consciously express owns informed consent.
  • have a prescription done by one of the CF Centre specialist Physicians of an IV antibiotic course of the expected duration of 2 weeks, due to a pulmonary exacerbation, with the association of ceftazidime 3 times daily and tobramycin once daily diluted in Normal Saline.
  • absence of clinical conditions that contraindicate the administration of 350ml of Normal Saline in 30 minutes 3 times daily and of 400ml of Normal Saline in 40 minutes.
  • no simultaneous anti-inflammatory therapy administered orally, IM or IV
  • 30 days have passed from the end of the previous course.
  • The IV course will be given to the subject as an inpatient, and he or she will be admitted to our hospital

Exclusion

    Key Trial Info

    Start Date :

    March 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2011

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00418470

    Start Date

    March 1 2007

    End Date

    August 1 2011

    Last Update

    October 29 2015

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Meyer Pediatric Hospital (Ospedale Pediatrico Meyer)

    Florence, Italy, 50132