Azithromycin in children who get admitted with severe respiratory difficulty in ICU

Azithromycin as an immunomodulator in children with Acute respiratory distress syndrome-Randomized double blinded placebo controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045942

Enrollment

Registered

2022-09-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: J960- Acute respiratory failure

Interventions

Intervention1: Azithromycin: IV Azithromycin would be given at a once daily dose of 20 mg/kg within 24hrs (i.e.) day1, subsequently on day2&3. This will be drawn from the vial (fully covered by tape

Eligibility

Inclusion criteria

Inclusion criteria: Mechanically ventilated children (1 month - 18 years) of age admitted with acute respiratory distress syndrome

Exclusion criteria

Exclusion criteria: 1)Children receiving Azithromycin as a part of treatment 2)Known Allergic reaction to Azithromycin 3)Patients with significant jaundice (Direct bilirubin >1.5mg/dl) 4)QT prolongation >450 milli-seconds/ abnormal heart rhythm

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of intravenous azithromycin as an immunomodulator in children (1 monthÃ¢â?¬â??18 years) with acute respiratory distress syndrome on 28-day mortalityTimepoint: 28-day mortality	—

Secondary

Measure	Time frame
To evaluate the effect of Azithromycin on the number of days for resolution of ARDSTimepoint: No of days for resolution of ARDS;To evaluate the effect of Azithromycin on ventilator free days during hospital stay (as on day 28)Timepoint: Ventillator free days as on day 28;To evaluate the impact of Azithromycin on the organ dysfunctionTimepoint: pSOFA score values would measured on pre(day1), and post intervention(day4&7) would be compared between two groups	—

Measure

Time frame

To evaluate the effect of Azithromycin on the number of days for resolution of ARDSTimepoint: No of days for resolution of ARDS;To evaluate the effect of Azithromycin on ventilator free days during hospital stay (as on day 28)Timepoint: Ventillator free days as on day 28;To evaluate the impact of Azithromycin on the organ dysfunctionTimepoint: pSOFA score values would measured on pre(day1), and post intervention(day4&7) would be compared between two groups

—

Countries

India

Contacts

Public ContactRakesh Lodha

AIIMS NEW DELHI

rakesh_lodha@hotmail.com9176419927

Outcome results

None listed

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