Efficacy and Safety of 28 or 56 Days Treatment With Inhaled Tobramycin Nebuliser Solution for Pseudomonas Aeruginosa Infection in Children With Cystic Fibrosis.
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Tobramycin Nebulised Solution (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
David Spencer, Principal Investigator, Affiliation: Royal Victoria Infirmary
Summary
This study assesses time to recurrence of infection with Pseudomonas aeruginosa following
treatment of the initial infection with tobramycin nebuliser solution. The safety of the
initial tobramycin treatment will be monitored over the first 3 months of the study and
patients will be followed for a further 24 months.
Clinical Details
Official title: Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic Fibrosis.
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Median time to recurrence of infection with Pseudomonas aeruginosa
Secondary outcome: Proportion of patients without P. aeruginosa diagnosis one month after finishing tobramycin treatment; Days in hospital and number of hospital admissions;Incidence of adverse events; Change in serum creatinine; Levels of tobramycin in serum; Change in hearing ability
Eligibility
Minimum age: 6 Months.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Written informed consent by subject and/or parent /legal guardian
- Male or female subjects at least 6 months old
- Diagnosis of cysticfibrosis based on first or early lower respiratory tract infection
with P. aeruginosa documented by either first P. aeruginosa isolated from sputum or
deep throat cough swab culture or by P. aeruginosa from sputum or deep throat cough
swab culture following at least 1 or 2 years of negative cultures and no
anti-pseudomonal treatment during this period.
Exclusion Criteria:
- History of aminoglycoside hypersensitivity or adverse reaction to inhaled
aminoglycoside
- Signs and symptoms of acute pulmonary disease such as pneumonia or pneumothorax
- Administration of any investigational drug within 30 days prior to enrollment.
- Administration of loop diuretics within 7 days prior to study drug administration.
- Personal/family history of abnormal hearing
- Abnormal result from an audiology testing
- Positive urine pregnancy test
- Use of macrolide antibiotics as a maintenance therapy for 12 or more days during the
28 days prior to Visit 1.
Other protocol specific inclusion/exclusion criteria may apply
Locations and Contacts
Additional Information
Starting date: November 2003
Ending date: February 2008
Last updated: December 20, 2007
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