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Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis

NCT00097773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2014-02-28

Study results available
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Summary

Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.

Conditions

Interventions

DRUG

Tobramycin solution for inhalation (TOBI)

Tobramycin solution for inhalation, 300 mg, administered twice daily for 28 days administered only when quarterly respiratory cultures are found positive for Pa.

DRUG

Oral placebo

Oral placebo for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive placebo, twice daily.

DRUG

Oral ciprofloxacin

Oral ciprofloxacin for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive oral ciprofloxacin, 15-20 mg/kg/dose, twice daily.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • CF Therapeutics Development Network Coordinating Center

    collaborator NETWORK

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Bonnie W. Ramsey · University of Washington

  • George Retsch-Bogart, MD · University of North Carolina, Chapel Hill

  • Miriam Treggiari, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2009-06-30
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00097773 on ClinicalTrials.gov