Evaluation of the efficacy and safety of tobramycin for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years.

• Conditions: ung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients.; MedDRA version: 14.1Level: LLTClassification code 10021860Term: Infection pseudomonas aeruginosaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2009-016590-15-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-14
• Last Update Posted: 28 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1.Written informed consent given by the parent/legal guardian on behalf of the subject; 2.Diagnosis of CF by one or more clinical features of CF: a documented sweat chloride test of > 60 mEq/L by quantitative pilocarpine iontophoresis; genotype with two identifiable CF-causing mutations; a positive newborn screening for CF; 3.Male and female subjects aged 3 months to less than 7 years of age at the time of screening; 4.Early lower respiratory tract infection with P. aeruginosa, defined by either of the following: infection defined as the first time P. aeruginosa is isolated from sputum or deep throat cough swab culture Or isolation of P. aeruginosa from sputum or deep-throat cough-swab culture after at least 1 year of negative cultures (documented with at least two negative cultures during the latter 1-year period, with no positive culture during that period), no antipseudomonal treatment by any route of administration during this one-year period; 5.Able to comply with all protocol requirements (except spirometry where not applicable); 6.Clinically stable in the opinion of the investigator.
Are the trial subjects under 18? yes
Number of subjects for this age range: 72
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Serum creatinine above the upper limit of the normal range for age; 2.Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics; 3.Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax; 4.Administration of any investigational drug within 30 days or 5 half-lives prior to enrollment, whichever is longer; 5.Administration of loop diuretics within 7 days prior to study drug administration; 6.Personal/family history of abnormal hearing; 7.Current (continuing, present at screening) or persisting abnormal result from audiology testing (defined as either a unilateral pure-tone audiometry test showing a threshold elevation > 20 dB at any frequency across the frequency range 0.25 kHz to 8 kHz or the absence of emission at the evoked otoacoustic emission test); 8.History of sputum culture, throat swab, or lower respiratory specimen culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B. cepacia at screening; 9.Hemoptysis which is clinically significant based on the subjects age and clinical status within 30 days prior to study drug administration; 10.History of malignancy of any organ system treated or untreated, regardless of whether there is evidence of local recurrence or metastases; 11.Subjects with clinically significant laboratory abnormalities including congenital diseases other than CF (not associated with the study indication) at screening; 12.Subjects with other clinically significant conditions (not associated with the study indication) at screening which might interfere with the assessment of this study; 13.Subjects or caregivers with a history of noncompliance to medical regimens and subjects or caregivers who are considered potentially unreliable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified