Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/12/2005
Date assigned
19/12/2005
Last edited
10/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr H.A.W.M. Tiddens

ORCID ID

Contact details

Erasmus Medical Center
Sophia Children’s 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

Sponsor information

Organisation

Chiron Corporated Ltd (Belgium)

Sponsor details

Generaal de wittelaan 19a b5
Mechelen
2800
Belgium

Sponsor type

Not defined

Website

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

  1. 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.

Additional files

Editorial Notes