To study benefits of Azithromycin in children suffering from bronchiectasis.

Effect of prophylactic long-term azithromycin therapy on non-cystic fibrosis bronchiectasis in children: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/11/029441

Enrollment

Registered

2020-11-27

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: J479- Bronchiectasis, uncomplicated

Interventions

Intervention1: Azithromycin: Azithromycin (10 mg/kg, maximum 500 mg) twice weekly for 24 months along with standard care. Control Intervention1: Standard care: Patients in standard care will receive r

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children aged 1-18 years with non-Cystic Fibrosis bronchiectasis with at least 1 pulmonary exacerbation in last 12 months. 2. Normal sweat chloride levels.

Exclusion criteria

Exclusion criteria: 1. Known/ suspected immune deficiency or immune dysregulation. 2. On long term azithromycin therapy ( > 2 week). 3. Known allergy to macrolides 4. Known underlying chronic liver or renal disease. 5. Regular follow up not possible

Design outcomes

Primary

Measure	Time frame
Number of acute pulmonary exacerbations over 24 months.Timepoint: Enrollment to 24 months of Azithromycin therapy.	—

Secondary

Measure	Time frame
Change in exercise capacity parameters (for children older than 12 years)Timepoint: baseline, at 1 and 2 years;Change in Quality of Life scoreTimepoint: baseline and every 6 months for 24 months;Change in spirometry and IOS parametersTimepoint: baseline and every 6 months for 24 months;Change in sputum/ induced sputum inflammatory pattern (Sputum cytology, Sputum IL-8, TNF-alpha, MMP-8, MMP-9, and TIMP-1 levelsTimepoint: baseline, 6 months and 1 year;Nasopharyngeal swab bacterial profile and azithromycin (macrolide) sensitivityTimepoint: baseline and every 6 months for 24 months;Number of children with positive sputum bacterial culture, bacterial profile and antibiotic sensitivityTimepoint: baseline and every 3 month for 24 months;Oxygen requirement, antibiotics use, or hospitalizationTimepoint: Follow up every 3 months for 24 months;Weight and height Z-scoreTimepoint: baseline and every 3 months for 24 months	—

Measure

Time frame

Change in exercise capacity parameters (for children older than 12 years)Timepoint: baseline, at 1 and 2 years;Change in Quality of Life scoreTimepoint: baseline and every 6 months for 24 months;Change in spirometry and IOS parametersTimepoint: baseline and every 6 months for 24 months;Change in sputum/ induced sputum inflammatory pattern (Sputum cytology, Sputum IL-8, TNF-alpha, MMP-8, MMP-9, and TIMP-1 levelsTimepoint: baseline, 6 months and 1 year;Nasopharyngeal swab bacterial profile and azithromycin (macrolide) sensitivityTimepoint: baseline and every 6 months for 24 months;Number of children with positive sputum bacterial culture, bacterial profile and antibiotic sensitivityTimepoint: baseline and every 3 month for 24 months;Oxygen requirement, antibiotics use, or hospitalizationTimepoint: Follow up every 3 months for 24 months;Weight and height Z-scoreTimepoint: baseline and every 3 months for 24 months

—

Countries

India

Contacts

Public ContactRakesh Lodha

Department of Pediatrics, AIIMS, Delhi

rlodha1661@gmail.com01126593621

Outcome results

None listed

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