A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included

• Conditions: ung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients; MedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: LLTClassification code 10068292Term: Pseudomonas colonizationSystem Organ Class: 100000004862; MedDRA version: 14.1Level: LLTClassification code 10068297Term: Pseudomonas colonisationSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2009-016590-15-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-11
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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:
a. The first time P. aeruginosa isolated
b. P. aeruginosa isolated 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)

5. Positive P. aeruginosa culture isolated from sputum, deep throat swab or nasopharyngeal aspiration specimens collected and tested from routine clinical culture performed at local site laboratory within 1 months prior to randomization

6. Able to comply with all protocol requirements (except spirometry where not applicable)
Clinically stable in the opinion of the investigator

Are the trial subjects under 18? yes
Number of subjects for this age range: 50
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. Any oral or iv anti-pseudomonal antibiotic treatment within 1 year prior to randomization

2. Serum creatinine above the upper limit of the normal range for age documented from at least one analysis performed at site laboratory within 6 month prior to randomization

3. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

4. Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax.

5. Administration of any investigational drug within 30 days or 5 half-lives prior to enrollment, whichever is longer.

6. Administration of loop diuretics within 7 days prior to study drug administration.

7. Personal/family history of abnormal hearing

8. 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).

9. 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.

10. Hemoptysis which is clinically significant based on the subjects age and clinical status within 30 days prior to study drug administration.

11. History of malignancy of any organ system treated or untreated, regardless of whether there is evidence of local recurrence or metastases,

12. Subjects with clinically significant laboratory abnormalities including congenital diseases other than CF (not associated with the study indication) documented from at least one laboratory chemistry and haematology analysis performed within 1 year prior to randomization

13. Subjects with other clinically significant conditions (not associated with the study indication) at screening which might interfere with the assessment of this study

14. 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