Treatment for severe pneumonia in children

Research on the Treatment of Severe Community-acquired Pneumonia in Children

This study is testing if giving glucocorticoids to children with severe pneumonia helps them get better faster compared to a placebo.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 1 Month to 18 Years
• Sex: All
• Sponsor: Beijing Children's Hospital (Academic / other)
• Locations: 3 sites (Baoding and 2 other locations)
• Trial ID: NCT05768204 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of glucocorticoid therapy in children suffering from severe community-acquired pneumonia. It is a multicenter, double-blind, randomized controlled trial involving 160 participants aged 1 month to under 18 years. Participants will receive either oral glucocorticoids or a placebo for five days, with careful monitoring of clinical symptoms and potential side effects. The goal is to provide high-quality evidence regarding the necessity of glucocorticoid treatment in this patient population.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 month to under 18 years with a clinical diagnosis of severe community-acquired pneumonia.

Not a fit: Patients who have previously received systemic corticosteroids for pneumonia or have hospital-acquired pneumonia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could clarify the role of glucocorticoids in treating severe pneumonia in children, potentially improving treatment outcomes.

How similar studies have performed: While the use of glucocorticoids in pneumonia treatment is debated, this study aims to fill a gap in high-quality clinical evidence, making it a novel approach.

Eligibility criteria

Inclusion Criteria:

1. 1 month-\< 18 years old.
2. Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes).
3. Meet any of the following:

   * (1) the general condition is very poor;
   * (2) refusal to eat or dehydration;
   * (3) Significantly increased respiratory rate (70 times/min \> infants, 50 times/min for older children\>);
   * (4) dyspnea (three concave sign, moaning, nasal flapping)
   * (5) hypoxemia (cyanosis, transcutaneous oxygen saturation\< 92% (not oxygenated));
   * (6) Pulmonary infiltration≥ 2/3 lung or multilobar infiltration;
   * (7) There is a pleural effusion;
   * (8) Extrapulmonary complications

Exclusion Criteria:

1. Systemic corticosteroids have been used to treat pneumonia before admission.
2. Use systemic glucocorticoids within 3 months before admission.
3. Hospital-acquired pneumonia.
4. Children with history of tuberculosis, branch expansion, tumors, immune deficiency, congenital heart, chronic pulmonary heart disease, kidney disease, severe malnutrition, recurrent respiratory infections, congenital bronchopulmonary dysplasia (BPD) and other underlying diseases.
5. Unconscious, need endotracheal intubation, children admitted to ICU.
6. Those who are allergic to the drugs or their preparation components involved in the study.
7. Those with hormonal contraindications: hypertension, diabetes, active peptic ulcer, adrenal hyperfunction, corneal ulcer, increased intraocular pressure, severe psychosis.
8. There is a current infection that is difficult to control with antibacterial drugs.
9. Children who are participating in other clinical trials.
10. The investigator believes that it is not suitable to participate in the study.

Where this trial is running

Baoding and 2 other locations

• Baoding Children's Hospital — Baoding, China (Recruiting)
• Beijing Children's Hospital — Beijing, China (Recruiting)
• Beijing Fangshan District Health Care Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Baoping Xu

Conditions Severe Pneumonia; Severe pneumonia; children; glucocorticoid; Randomized Controlled Trial