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
Protocol serial number	NTR377
Sponsor	Chiron Corporated Ltd (Belgium)
Funder	Chiron Corporation Ltd (Belgium)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr H.A.W.M. Tiddens
Scientific

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

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

Primary study design	Interventional
Study design	Multicentre randomised open label parallel group trial
Secondary study design	Non randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tobramycine
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/09/2007

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

Erasmus Medical Center

Rotterdam
3015 GJ
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2010		Yes	No