The effect of macrolide antibiotics on the outcome of acute bronchiolitis in infants
| ISRCTN | ISRCTN09839570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09839570 |
| Secondary identifying numbers | N0544103921 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 05/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew T Clark
Scientific
Scientific
Box No 40
Clinic 2a
Department of Allergy & Clinical Immunology
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The effect of macrolide antibiotics on the outcome of acute bronchiolitis in infants |
| Study objectives | The effect of macrolide antibiotics on the outcome of acute bronchiolitis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Clarithromycin |
| Primary outcome measure | Outcome measures will include a daily clinical score and number of days hospitalisation |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 16/10/2001 |
| Completion date | 15/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 16/10/2001 |
| Date of final enrolment | 15/10/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's NHS Trust
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Other
Cambridge Consortium - Addenbrooke's (UK)
No information available
Results and Publications
| 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 |
Editorial Notes
05/02/2018: No publications found, verifying study status with principal investigator.
