Contact information
Type
Scientific
Primary contact
Dr H.A.W.M. Tiddens
ORCID ID
Contact details
Erasmus Medical Center
Sophia Childrens Hospital Rotterdam
Department of Pediatric Pulmonology
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636363
h.tiddens@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR377
Study information
Scientific title
Acronym
ELITE
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Multicentre randomised open label parallel group trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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 names
Tobramycine
Primary outcome measures
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 trial start date
01/10/2003
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/10/2003
Recruitment end date
30/09/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3015 GJ
Netherlands
Funders
Funder type
Industry
Funder name
Chiron Corporation Ltd (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19996339
Publication citations
-
Results
Ratjen F, Munck A, Kho P, Angyalosi G, , Treatment of early Pseudomonas aeruginosa infection in patients with cystic fibrosis: the ELITE trial., Thorax, 2010, 65, 4, 286-291, doi: 10.1136/thx.2009.121657.