To see the effect of corticosteroids along with standard treatment in Pneumonia

Phase 3

Completed

• Conditions: Health Condition 1: J159- Unspecified bacterial pneumonia

• Registration Number: CTRI/2021/09/036799
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 132

Inclusion Criteria

All cases severe pneumonia will be diagnosed by following criteria:

i) 2 months to 59 months: WHO criteria for severe pneumonia will be used.

ii) 5 to 15 years: Child need to have tachypnea RR >20/min, fever >38 C, SPo2 <94% and radiological changes in CXR to include as severe pneumonia in our study.

Exclusion Criteria

1.Prior treatment with corticosteroids in past 3 months

2.Immunological deficiencies state

3.Prexisting liver, kidney or cardiac disease

4.Nosocomial pneumonia

5.Brochiolitis, bronchial asthma, empyema thoracics, persistent or recurrent pneumonia

6.Hemodynamically instability

7.Severe acute malnutrition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the effect of dexamethasone therapy to reduce the clinical failure in children aged 2 month to 15 years with severe community acquired pneumonia.Timepoint: Clinical failure in first 72 hours

Secondary Outcome Measures

Name	Time	Method
Secondary1.To compare the <br/ ><br>a. mortality, <br/ ><br>b. the duration of the hospital stays, <br/ ><br>c. need for mechanical ventilation, <br/ ><br>d. readmission rate within one month <br/ ><br>e. complications of pneumonia between two groups. <br/ ><br>2.To assess the severity of inflammation by assessing (ESR, hsCRP, IL-6,Il 8,IL 10,Procalcitonin) at time of admission and day 4 (after the stopping the steroid therapy) or at the time of discharge. <br/ ><br>Timepoint: To see the inflammatory markers before starting the intervention or placebo and after 72 hours or at time of discharge