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van CCT (UK)


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van CCT (UK)


Elite study.


- candidate number1589
- NTR NumberNTR377
- ISRCTNISRCTN80955954
- Date ISRCTN created19-dec-2005
- date ISRCTN requested28-okt-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleElite study.
- Scientific TitleThe 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.
- ACRONYMELITE
- hypothesisTo assess the duration of treatment ( 28 or 56 days) with inhaled tobramycine nebuliser solution of early onset pseudomonas infection in subjects with CF.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Pseudomonas infection
- Inclusion criteria1. Male or female subject > 6 months;
2. Diagnosis of CF;
3. First or early lower resp. tract infection with P aeruginosa.
- Exclusion criteria1. History of aminoglycoside hypersensitivity symptoms of acute pulmonary disease invest. drugs within 30 days prior to enrollment;
2. Abnormal result from audiology testing.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2003
- planned closingdate30-sep-2007
- Target number of participants120
- Interventions- 5x blood sample
- 11x lungfunction testing
- 11x swabculture
- 4x audiology testing
- Primary outcomeThe 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 outcome1. 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 to assess the safety of patients in the two treatment arms;
2. To assess the proportion of patients requiring hospitalisation for pulmonary exacerbation.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. H.A.W.M. Tiddens
- CONTACT for SCIENTIFIC QUERIESDr. H.A.W.M. Tiddens
- Sponsor/Initiator Chiron corporated ltd
- Funding
(Source(s) of Monetary or Material Support)
Chiron corporated ltd
- PublicationsN/A
- Brief summaryOpen label randomised multicenter observational study in the following treatment groups: 300 mg TNS given for 28 days and 300 mg TNS given for 56 days.
- Main changes (audit trail)
- RECORD12-sep-2005 - 5-jan-2010


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