Role of Azithromycin in children with acute exacerbation of asthma

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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028478

Enrollment

200

Registered

2020-10-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J453- Mild persistent asthma Health Condition 2: J459- Other and unspecified asthma Health Condition 3: J459- Other and unspecified asthma

Interventions

Intervention1: Azithromycin with Standard treatment: A randomized controlled trial study design will be used. Two hundred will be enrolled in study with hundred patients in each group. The patients wi

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary outcome will be assessed on day 4 of initial treatment by following parameters : Duration of respiratory symptoms to resolve i.e. 1. Difficulty in breathing 2. Fast breathing 3. Noisy breathing, 4. Chest tightness or chest pain 5. Persistent cough 6. Any adverse effect of drug like diarrohea , drug allergy , palpitation Timepoint: day of presentation , day 4th ,day 14th	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactDr Chetna Tholia

PT..B.D.SHARMA PGIMS, ROHTAK

chetna22tholia@gmail.com9992778475

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026