Dutch Antibiotics in Respiratory syncytial virus infection Trial

ISRCTN	ISRCTN86554663
DOI	https://doi.org/10.1186/ISRCTN86554663
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M C J Kneyber
Scientific

VU University Medical Centre
Office 8 D 11
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone	+31 (0)20 444 2413
Email	m.kneyber@vumc.nl

Study design	Randomised, placebo controlled, parallel group, double blinded multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Dutch Antibiotics in Respiratory syncytial virus infection Trial
Study acronym	DART
Study objectives	Antibiotic treatment of hospitalised children with Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV LRTD) has no beneficial effect on the clinical course.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Respiratory tract infection, Bronchiolitis, Pneumonia, Respiratory Syncytial Virus (RSV)
Intervention	Azithromycine 10 mg/kg/day for three days versus placebo.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Azithromycine
Primary outcome measure	Duration of hospitalisation
Secondary outcome measures	1. Proportion and duration of oxygen therapy 2. Proportion and duration of bronchodilator therapy 3. Duration of tachypnoe (more than 40 breaths/min) 4. Duration of fever (more than 37.5°C) 5. Duration of impaired feeding 6. Number of infants referred to Paediatric Intensive Care Unit (PICU) 7. Course of RSV score
Overall study start date	01/10/2001
Completion date	01/04/2006

Participant type(s)	Patient
Age group	Child
Upper age limit	24 Months
Sex	Not Specified
Target number of participants	120
Total final enrolment	71
Key inclusion criteria	Children less than 24 months of age with a virologically confirmed diagnosis of RSV LRTD, defined by a first episode of dyspnoea with increased body temperature (more than 37.5°C), and/or cough, coryza, wheezing, crackles on pulmonary auscultation.
Key exclusion criteria	1. Age more than 24 months 2. Children presenting with apnoea with signs of lower respiratory tract disease 3. Nosocomial RSV infection 4. Antibiotic treatment less than seven days before hospital admission 5. Absence of informed consent by parents or legal representatives
Date of first enrolment	01/10/2001
Date of final enrolment	01/04/2006

VU University Medical Centre

Amsterdam
1007 MB
Netherlands

VU University Medical Centre (The Netherlands)
University/education

Department of Pediatrics
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Website	http://www.vumc.nl/english/
"ROR"	https://ror.org/00q6h8f30

Not defined

Not provided at time of registration

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2008	07/01/2021	Yes	No

07/01/2021: Publication reference and total final enrolment added.