Azithromycin as an add-on drug in children aged 5-14 years with acute exacerbation of asthma
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 4.Chest tightness or chest pain
Study Overview
Brief Summary
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. Pearson’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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 5.00 Year(s) to 14.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
4.Chest tightness or chest pain
Time Frame: day of presentation , day 4th ,day 14th
6.Any adverse effect of drug like diarrohea , drug allergy , palpitation
Time Frame: day of presentation , day 4th ,day 14th
1.Difficulty in breathing
Time Frame: day of presentation , day 4th ,day 14th
Primary outcome will be assessed on day 4 of initial treatment by following parameters :
Time Frame: day of presentation , day 4th ,day 14th
Duration of respiratory symptoms to resolve i.e.
Time Frame: day of presentation , day 4th ,day 14th
5.Persistent cough
Time Frame: day of presentation , day 4th ,day 14th
2.Fast breathing
Time Frame: day of presentation , day 4th ,day 14th
3.Noisy breathing,
Time Frame: day of presentation , day 4th ,day 14th
Secondary Outcomes
- Detection of IgM Mycoplasma pneumonia in peripheral blood sample by ELISA method in children aged 5-14 years with acuteexacerbation of asthma(on day of addmission)