Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
16/10/2015
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 Andrew T Clark

ORCID ID

Contact details

Box No 40
Clinic 2a
Department of Allergy & Clinical Immunology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544103921

Study information

Scientific title

The effect of macrolide antibiotics on the outcome of acute bronchiolitis in infants

Acronym

Study hypothesis

The effect of macrolide antibiotics on the outcome of acute bronchiolitis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory: Acute bronchiolitis

Intervention

The project involves enrolment of infants with bronchiolitis (a wheezy respiratory illness). Subjects will be randomised to receive either 5 days of clarithromycin suspension or placebo in double-blinded fashion.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Outcome measures will include a daily clinical score and number of days hospitalisation.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

16/10/2001

Overall trial end date

15/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

16/10/2001

Recruitment end date

15/10/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box No 40
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Other

Funder name

Cambridge Consortium - Addenbrooke's (UK)

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