search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Dutch Antibiotics in RSV infection Trial.


- candidate number1233
- NTR NumberNTR142
- ISRCTNISRCTN86554663
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR24-aug-2005
- Secondary IDsN/A 
- Public TitleDutch Antibiotics in RSV infection Trial.
- Scientific TitleA randomized, double-blind, placebo-controlled trial on the efficacy of oral azithromycin for hospitalised children with respiratory syncytial virus lower respiratory tract disease.
- ACRONYMDART
- hypothesisAntibiotic treatment of hospitalised children with RSV LRTD has no beneficial effect on the clinical course.
- Healt Condition(s) or Problem(s) studiedRespiratory tract infection, Bronchiolitis, Pneumonia, Respiratory Syncytial Virus (RSV)
- Inclusion criteriaChildren <24 months of age with a virologically confirmed diagnosis of RSV lower respiratory tract disease, defined by a first episode of dyspnoea with increased body temperature (> 37.5 C), and/or cough, and/or coryza, and/or wheezing, and/or crackles on pulmonary auscultation.
- Exclusion criteriaAge >24 months, children presenting with apnoea with signs of lower respiratory tract disease, nosocomial RSV infection, antibiotic treatment less than 7 days before hospital admission, abscence of informed consent by parents or legal representatives.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2001
- planned closingdate1-apr-2006
- Target number of participants120
- InterventionsAzithromycine 10 mg/kg/day for three days versus placebo.
- Primary outcomeDuration of hospitalisation.
- Secondary outcome1. Proportion and duration of oxygen therapy;
2. Proportion and duration of bronchodilator therapy;
3. Duration of tachypnoe (>40 breaths/min);
4. Duration of fever (> 37.5C);
5. Duration of impaired feeding;
6. Number of infants referred to PICU Course of RSV score.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. M.C.J. Kneyber
- CONTACT for SCIENTIFIC QUERIESDr. M.C.J. Kneyber
- Sponsor/Initiator VU University Medical Center, Department of Pediatrics
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsPediatr Pulmonol. 2008 Feb;43(2):142-9.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-aug-2005 - 11-nov-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl