|
Main
|
|
Note: This record shows only 22 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:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN86554663 |
|
Date of registration:
|
20/12/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Dutch Antibiotics in Respiratory syncytial virus infection Trial
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
01/10/2001 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN86554663 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomised, placebo controlled, parallel group, double blinded multicentre trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
M C J
Kneyber |
|
Address:
|
VU University Medical Centre
Office 8 D 11,
P.O. Box 7057
1007 MB
Amsterdam
Netherlands |
|
Telephone:
|
+31 (0)20 444 2413 |
|
Email:
|
m.kneyber@vumc.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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.
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
Age minimum:
Age maximum:
Gender:
Not Specified
|
|
Health Condition(s) or Problem(s) studied
|
Respiratory tract infection, Bronchiolitis, Pneumonia, Respiratory Syncytial Virus (RSV)
Respiratory
Respiratory tract infection
|
|
Intervention(s)
|
|
Azithromycine 10 mg/kg/day for three days versus placebo.
|
|
Primary Outcome(s)
|
|
Duration of hospitalisation
|
|
Secondary Outcome(s)
|
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
|
|
Source(s) of Monetary Support
|
|
Not provided at time of registration
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|