Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001031257
Ethics application status
Approved
Date submitted
25/11/2009
Date registered
30/11/2009
Date last updated
30/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of azitromycin on Hospitalized Infants With Acute Bronchiolitis: A Randomized, prospective, double-blind, placebo-controlled study.
Scientific title
Effects of azitromycin on length of hospital stay in Infants With Acute Bronchiolitis: A Randomized, prospective, double-blind, placebo-controlled study.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Viral Bronchiolitis 252302 0
Condition category
Condition code
Respiratory 252469 252469 0 0
Other respiratory disorders / diseases
Infection 252470 252470 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Azitromycin - oral syrup
Dose 10mg/kg/day - oral 7 days
Intervention code [1] 241607 0
Treatment: Drugs
Comparator / control treatment
Placebo, micro cellulose syrup, in the same amount that azitromycin (10mg/kg/day) - oral - 7 day
Control group
Placebo

Outcomes
Primary outcome [1] 253345 0
Reduction in the length of hospital stay (length of the hospital stay or the time until the infant was ready for discharge according medical records).
Timepoint [1] 253345 0
Hours of hospital stay
Secondary outcome [1] 262422 0
Duration of need for supplemental oxygen, assessed by medical and nursing records.
Timepoint [1] 262422 0
Hours of supplemental oxygen

Eligibility
Key inclusion criteria
Infants less than 7 months of age who were admitted to Hospital de Clínicas de Porto Alegre between March 2009 and July 2010 with a first episode of wheezing requiring hospitalization and supplemental oxygen, with a clinical diagnosis of bronchiolitis
Minimum age
10 Days
Maximum age
7 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with cardiac, metabolic disease or clinically significant respiratory disease, such as cystic fibrosis, were not eligible, although infants with chronic neonatal lung disease associated with prematurity were included. Infants were excluded if they had received corticosteroids in any form within 7days before presentation or had received macrolides before presentation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After written informed parental consent had been obtained, the infants were randomly assigned to receive seven doses of azitromicin or placebo, after 12 hours after their admission to the hospital. Allocaction was concealed contacting the holder of the allocation schedule who was “off-site”
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 2341 0
Brazil
State/province [1] 2341 0

Funding & Sponsors
Funding source category [1] 256088 0
Hospital
Name [1] 256088 0
Hospital de Clinicas de Porto Alegre
Country [1] 256088 0
Brazil
Primary sponsor type
University
Name
Universidade Federal do Rio Grande do Sul
Address
Rua Ramiro Barcelos, 2400
2nd Floor
Porto Alegre RS
Brazil
ZIP CODE= CEP 90035-003
Country
Brazil
Secondary sponsor category [1] 251431 0
None
Name [1] 251431 0
Address [1] 251431 0
Country [1] 251431 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258179 0
Comite de Etica em Pesqquisa (CEP) - Grupo de Pesquisa e Pos Graduacao (GPPG) Hospital de Clinicas de Porto Alegre
Ethics committee address [1] 258179 0
Rua Ramiro Barcelos, 2350
Porto Alegre - RS - Brazil
ZIP CODE= CEP 90035-003
Ethics committee country [1] 258179 0
Brazil
Date submitted for ethics approval [1] 258179 0
Approval date [1] 258179 0
Ethics approval number [1] 258179 0

Summary
Brief summary
The primary purpose of the study is evaluate the efficacy of azitromycin (a drug) in infants less than 7 months of age with acute viral bronchiolitis, by reducing the length of hospital stay.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30551 0
Address 30551 0
Country 30551 0
Phone 30551 0
Fax 30551 0
Email 30551 0
Contact person for public queries
Name 13798 0
Daniel Cardoso Barbosa
Address 13798 0
Rua Ramiro Barcelos, 2350
Emergência Pediátrica
Porto Alegre - RS
Brazil
ZIP CODE = CEP 90035-003
Country 13798 0
Brazil
Phone 13798 0
55 51 3359-8213
Fax 13798 0
Email 13798 0
[email protected]
Contact person for scientific queries
Name 4726 0
Daniel Cardoso Barbosa
Address 4726 0
Rua Ramiro Barcelos, 2350
Emergência Pediátrica
Porto Alegre - RS
Brazil
ZIP CODE = CEP 90035-003
Country 4726 0
Brazil
Phone 4726 0
55 51 3359-8213
Fax 4726 0
Email 4726 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.