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Effect of dexamethasone in children with severe community acquired pneumonia

Dexamethasone in severe community acquired pneumonia in children: A pilot double-blind randomized controlled trial - DexCAP trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108165
Enrollment
120
Registered
2026-04-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: J189- Pneumonia, unspecified organism

Interventions

Intervention1: Intravenous dexamethasone: Dexamethasone, at a dose of 0.1 mg/kg, intravenously, once a day Control Intervention1: Placebo: Normal saline, 0.1 mL/kg intravenously, once a day

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 year to 12 years. Clinico-radiologic diagnosis of severe community acquired pneumonia

Exclusion criteria

Exclusion criteria: Children on systemic glucocorticoids for any other indication. Children on antibiotics for more than 5 days at the time of enrolment. Children with history of chronic lung disease. Children with congenital heart disease. Children with empyema. Children with tuberculosis or fungal infection. Children with any extrapulmonary organ dysfunction as defined in the Phoenix sepsis guidelines. Children with immunocompromised status (on chemotherapy, immunosuppressants, bone marrow failure, immunodeficiency, or hematopoietic stem cell transplant recipients). Children with severe acute malnutrition. Children with healthcare associated pneumonia.

Design outcomes

Primary

MeasureTime frame
Feasibility of administration of dexamethasone to children with severe CAP in terms of recruitment rate and adherence to the protocolTimepoint: Day 5 of enrollment

Secondary

MeasureTime frame
Time to defervescence Duration of supplemental oxygen Requirement & duration of mechanical ventilation Length of PICU & hospital stay. Mortality. Adverse effects: Hyperglycemia, hypertension, gastrointestinal bleeding, secondary infections. Complications: development of empyema, pneumothorax, or requirement of surgical procedures. Timepoint: Till discharge or at day 28, whichever is earlier.

Countries

India

Contacts

Public ContactSuresh Kumar Angurana

PGIMER

sureshangurana@gmail.com9855373969

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026