Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00147

2 Trial Registration Date

2007-12-18

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Departmental

5 Primary Sponsor

Department of Paediatrics, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Albert Martin LI

ii Address

Department of Paediatrics, PWH, Shatin, Hong Kong

iii Phone

Telephone #: 26322859; Fax #: 26360020;

iv Email

email: albertm68mcli@yahoo.com

v Affiliation

Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Albert Martin LI

ii Address

Department of Paediatrics, PWH, Shatin, Hong Kong

iii Phone

Telephone #: 26322859; Fax #: 26360020;

iv Email

email: albertm68mcli@yahoo.com

v Affiliation

Department of Paediatrics, Faculty of Medicine, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

A randomized controlled study of the effectiveness of azithromycin in preventing post-respiratory syncytial virus bronchiolitis wheezing

10 Public Title

A randomized controlled study of the effectiveness of azithromycin in preventing post-respiratory syncytial virus bronchiolitis wheezing

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-12-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Post-respiratory syncytial virus bronchiolitis wheezing

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Azithromycin

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 days

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: 1. previously well infants less than or equal to 12 months of age; 2. first episode of wheezing requiring hospitalization, and with a clinical diagnosis of bronchiolitis. Bronchiolitis is diagnosed based on clinical findings including wheezing or wheezing with crackles preceded by upper respiratory tract infection symptoms, and respiratory distress with retractions; 3. admitted in hospital for <24 hours; 4. laboratory confirmed presence of RSV in nasopharyngeal aspirate, and 5. signed written informed consent.

ii Exclusion Criteria

Exclusion criteria: 1. infants with any cardio-respiratory illness, immunodeficiency or were born prematurely (gestational age <37 weeks); 2. infants who had received corticosteroids within 24 hours before presentation; 3. infants who had received antibiotic treatment less than seven days before hospital admission, and 4. infants requiring mechanical ventilation.

iii Age Minimum

term baby (gestational age >=37 weeks)

iv Age Maximum

12 months

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-02-15

21 Target Sample Size

70

22 Recruitment Status

Unknown

23 Primary Outcome

The primary outcome is the number of wheezing attacks in the following 12 months after the initial illness.

24 Secondary Outcome

Secondary outcomes include length of hospital stay (LOS) (in hours) defined as the time between study entry and the actual time that the subject is declared fit for discharge.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-06-22

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000708

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2013-06-22