Azithromycin as an add-on drug in children aged 5-14 years with acute exacerbation of asthma

未提供1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2020年10月25日最近更新: 2020年10月19日

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The present study shall be conducted in Department of Pediatrics, Post Graduate Institute

of Medical Sciences, Rohtak. Study participants shall be taken from Pediatrics OPD,

Emergency and Pediatrics indoor wards. The study will begin only after seeking approval

from institutional ethics committee (IEC). Attendants of children shall be explained about

the study and written informed consent shall be taken from them. For children aged more

than 7 years consent will be taken from patient also .After taking a thorough history, each

participant shall undergo detailed clinical examination, then trial after randomization.

A randomized controlled trial study design will be used. Two hundred will be enrolled in

study with hundred patients in each group after taking into account of sample size of

various previous studies and as per principle of undertaking feasibility and research

possibility. Baseline ECG will be done in all patient to rule out any Q-T prolongation. The

patients will be randomized into two groups using computer generated randomization

sequence. In intervention group, the patients will receive oral azithromycin (Oral 10mg /kg

body weight) along with standard therapy (inhaled B 2 agonist, inhaled and/or systemic

corticosteroids) and in control group, patients will receive standard therapy alone. Danger

signs like allergic reaction, palpitation etc will be explained to attendant of patient who are

receiving azithromycin. They will be advised to report in emergency room if any danger

sign develops. Both group will be compared in terms of proportion of patient relieved of

respiratory symptoms on day 4 and quality of life 14 th day. In all the children

Immunoglobulin M (IgM) antibodies will be serologically determined for Mycoplasma pneumoniae. The comparison among

two groups will be done on the basis of response to treatment on

day 4, quality of life assessment by using Mini PAQLQ score on day 14 .

The patients will be assessed on 4 th day and after 2 week. The data thus obtained will be

entered in the current version of Microsoft-Excel and percentage proportion will be

calculated. Pearsonâ€™s chi-squared test and student t test will be applied to test the

significance of the results using current version of SPSS (Statistical Package for Social

Sciences) software version. P<0.05 will be considered significant.

•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.