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

Erasmus Medical Center
Sophia Children’s Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Phone +31 (0)10 4636363
Email h.tiddens@erasmusmc.nl

Study information

Study designMulticentre randomised open label parallel group trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymELITE
Study objectivesTo 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) studiedCystic fibrosis, Pseudomonas infection
InterventionTreatment 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Tobramycine
Primary outcome measureThe 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 measures1. 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 date01/10/2003
Completion date30/09/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants120
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/2003
Date of final enrolment30/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands

Sponsor information

Chiron Corporated Ltd (Belgium)
Not defined

Generaal de wittelaan 19a b5
Mechelen
2800
Belgium

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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