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
| ISRCTN | ISRCTN80955954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80955954 |
| Secondary identifying numbers | NTR377 |
- Submission date
- 19/12/2005
- Registration date
- 19/12/2005
- Last edited
- 10/12/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H.A.W.M. Tiddens
Scientific
Scientific
Erasmus Medical Center
Sophia Childrens Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636363 |
|---|---|
| h.tiddens@erasmusmc.nl |
Study information
| Study design | Multicentre randomised open label parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ELITE |
| Study objectives | To assess the duration of treatment (28 or 56 days) with inhaled tobramycine nebuliser solution (TNS) of early onset pseudomonas infection in subjects with cystic fibrosis (CF). |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Cystic fibrosis, Pseudomonas infection |
| Intervention | Treatment with inhaled tobramycine nebuliser solution (TNS) 300 mg twice daily for either 28 days or 56 days. 5 x blood sample, 11 x lung function testing, 11 x swab culture, 4 x audiology testing |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tobramycine |
| Primary outcome measure | 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 measures | 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 2. To assess the safety of patients in the two treatment arms 3. To assess the proportion of patients requiring hospitalisation for pulmonary exacerbation |
| Overall study start date | 01/10/2003 |
| Completion date | 30/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Male or female subjects greater than 6 months 2. Diagnosis of CF 3. First or early lower respiratory tract infection with Pseudomonas aeruginosa |
| Key exclusion criteria | 1. History of aminoglycoside hypersensitivity 2. Symptoms of acute pulmonary disease 3. Investigational drugs within 30 days prior to enrolment 4. Abnormal result from audiology testing |
| Date of first enrolment | 01/10/2003 |
| Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Chiron Corporated Ltd (Belgium)
Not defined
Not defined
Generaal de wittelaan 19a b5
Mechelen
2800
Belgium
"ROR" |
https://ror.org/05he4e720 |
|---|
Funders
Funder type
Industry
Chiron Corporation Ltd (Belgium)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | Yes | No |
