No registrations found.
ID
Source
Brief title
Health condition
CF
pos. pseudomonas infection
Sponsors and support
generaal de witte laan 19a b5
2800 mechelen belgie
generaal de witte laan 19a b5
2800 mechelen belgie
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Open label randomised multicenter observational study in the following treatment groups: 300 mg TNS given for 28 days and 300 mg TNS given for 56 days.
Study objective
To assess the duration of treatment ( 28 or 56 days) with inhaled tobramycine nebuliser solution of early onset pseudomonas infection in subjects with CF.
Study design
N/A
Intervention
- 5x blood sample
- 11x lungfunction testing
- 11x swabculture
- 4x audiology testing
Dr. Molewaterplein 60
H.A.W.M. Tiddens
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636690 / +31 (0)10 4636363 (general)
h.tiddens@erasmusmc.nl
Dr. Molewaterplein 60
H.A.W.M. Tiddens
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636690 / +31 (0)10 4636363 (general)
h.tiddens@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL340 |
| NTR-old | NTR377 |
| Other | : N/A |
| ISRCTN | ISRCTN80955954 |