Condition category
Respiratory
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/03/2007
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 M C J Kneyber

ORCID ID

Contact details

VU University Medical Centre
Office 8 D 11
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2413
m.kneyber@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DART

Study hypothesis

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

Ethics approval received from the local medical ethics committee

Study design

Randomised, placebo controlled, parallel group, double blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Respiratory tract infection, Bronchiolitis, Pneumonia, Respiratory Syncytial Virus (RSV)

Intervention

Azithromycine 10 mg/kg/day for three days versus placebo.

Intervention type

Drug

Phase

Not Specified

Drug names

Azithromycine

Primary outcome measures

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 trial start date

01/10/2001

Overall trial end date

01/04/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

120

Participant 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

Recruitment start date

01/10/2001

Recruitment end date

01/04/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Organisation

VU University Medical Centre (The Netherlands)

Sponsor details

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

Sponsor type

University/education

Website

http://www.vumc.nl/english/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

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

Publication citations

Additional files

Editorial Notes