Elite study.

The microbiological efficacy and safety of two treatment regimens of inhaled tobramycine nebuliser solution (TNS) for the treatment of early onset pseudomonas aeruginosa lower respiratory tract infection in subjects with cystic fibrosis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23558

Enrollment

120

Registered

2005-09-12

Start date

2003-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CF pos. pseudomonas infection

Interventions

- 5x blood sample - 11x lungfunction testing - 11x swabculture - 4x audiology testing

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female subject > 6 months; 2. Diagnosis of CF; 3. First or early lower resp. tract infection with P aeruginosa.

Exclusion criteria

Exclusion criteria: 1. History of aminoglycoside hypersensitivity symptoms of acute pulmonary disease invest. drugs within 30 days prior to enrollment; 2. Abnormal result from audiology testing.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to estimate the duration of eradication of any strain of P aeruginosa infection during the 27 month study period following TNS treatment of early infection in cystic fibrosis patients.	—

Secondary

Measure	Time frame
1. To estimate the proportion of subjects free form P aeruginosa at visit 5 with 300 mg twice daily for either 28 days or 56 days to assess the safety of patients in the two treatment arms; 2. To assess the proportion of patients requiring hospitalisation for pulmonary exacerbation.	—

Contacts

Public ContactH.A.W.M. Tiddens

Erasmus Medical Center, Sophia Children’s Hospital Rotterdam, Department of Pediatric Pulmonology, Dr. Molewaterplein 60

h.tiddens@erasmusmc.nl+31 (0)10 4636690 / +31 (0)10 4636363 (general)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)