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Role of Azithromycin in children with acute exacerbation of asthma

Phase 3
Conditions
Health Condition 1: J453- Mild persistent asthmaHealth Condition 2: J459- Other and unspecified asthmaHealth Condition 3: J459- Other and unspecified asthma
Registration Number
CTRI/2020/10/028478
Lead Sponsor
I
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

children aged 5-14 years presenting with acute exacerbation of asthma

Exclusion Criteria

1.Children with heart ,liver ,neurological or kidney diseases.

2.Children with evidence of pneumonia

3.Children with respiratory rate more than 50, or fever more than 39 degree Celsius.

4.Children with abnormal development of airways ,congenital respiratory tract diseases

5.Children with metabolic and autoimmune diseases.

6.Children with known Q-T interval prolongation

7.Children with macrolide allergy

8.Children taking medication which prolongs Q-T interval

9.Children using oral and systemic antibiotic within 28 days of enrollment

10.Children who needs intensive care

11.Children with history of tachyarrhythmia and /or bradyarrhythmia

12.Caregivers who are not willing to give informed written consent

13.Children with recurrent chest infections

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome will be assessed on day 4 of initial treatment by following parameters : <br/ ><br> Duration of respiratory symptoms to resolve i.e. <br/ ><br>1.Difficulty in breathing <br/ ><br>2.Fast breathing <br/ ><br>3.Noisy breathing, <br/ ><br>4.Chest tightness or chest pain <br/ ><br>5.Persistent cough <br/ ><br>6.Any adverse effect of drug like diarrohea , drug allergy , palpitation <br/ ><br>Timepoint: day of presentation , day 4th ,day 14th <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
Detection of IgM Mycoplasma pneumonia in peripheral blood sample by ELISA method in children aged 5-14 years with acuteexacerbation of asthmaTimepoint: on day of addmission
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