|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
REBEC |
|
Last refreshed on:
|
29 April 2013 |
|
Main ID: |
RBR-257zbc |
|
Date of registration:
|
04/01/2012 |
|
Primary sponsor: |
|
|
Public title:
|
Study of the effect of a new treatment with antibiotic in babies with brochiolitis.
|
|
Scientific title:
|
Using azithromycin to reduce bronchiolitis length of hospital stay in infants. |
|
Date of first enrolment:
|
01/09/2010 |
|
Target sample size:
|
150 |
|
Recruitment status: |
recruiting |
|
URL:
|
http://www.ensaiosclinicos.gov.br/rg/RBR-257zbc/ |
|
Study type:
|
|
|
Study design:
|
Clinical trial, randomized, two arm, doble-blind, phase II.
|
|
|
Countries of recruitment
|
|
Brazil
| | | | | | | |
|
Contacts
|
|
Name:
|
Renato
Stein |
|
Address:
|
Av. Ipiiranga 6690
90610000
Porto Alegre
Brazil |
|
Telephone:
|
51-33364211 |
|
Email:
|
rstein@pucrs.br |
|
Affiliation:
|
PUCRS |
|
|
Name:
|
Leonardo
Pinto |
|
Address:
|
Avenida Ipiranga 6690, Hospital São Lucas, 2o andar, IPB
90610-000
Porto Alegre
Brazil |
|
Telephone:
|
51 3320-300, R2313 |
|
Email:
|
leonardo.pinto@pucrs.br |
|
Affiliation:
|
PUCRS |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Infants younger than 12 months, with diagnosis of acute bronchiolitis and hospitalization for at least 24 hours.
Exclusion criteria: Chronic lung disease, cystic fibrosis, congenital heart diseases and previous use of macrolides.
Age minimum:
1W
Age maximum:
12M
Gender:
-
|
|
Health Condition(s) or Problem(s) studied
|
Acute viral bronchiolitis
C08.127.446.135
|
|
J00-J99
|
|
Intervention(s)
|
|
Treatment with azythromycin per oral.
|
|
Primary Outcome(s)
|
|
Length of hospitalization: number of days of hospitalization, mesuared by date of discharge - date of hospitalization.
|
|
Secondary Outcome(s)
|
|
Length of need of oxygen therapy: number of days of oxygen use, mesuared by the day when oxygen prescription was cancelled - first day of oxygen prescription.
|
|
Secondary ID(s)
|
|
0171.0.002.000-09
|
|
09/04678
|
|
Source(s) of Monetary Support
|
|
Fundação de Amparo a Pesquisa do Estado do Rio Grande do Sul - Brazil
|
|