Clinical trial NCT05768204: Research on the Treatment of Severe Community-acquired Pneumonia in Children
Official title: Research on the Treatment of Severe Community-acquired Pneumonia in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Severe Pneumonia
Keywords: Severe pneumonia
children
glucocorticoid
Randomized Controlled Trial
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia.

Detailed description: The use of glucocorticoid for severe community-acquired pneumonia in children is still controversial in clinic. There is still a lack of high quality clinical research results in this field. That's the purpose of this study. The study used oral glucocorticoids and placebos. It was a multicenter clinical study involving 160 people. The enrolled subjects were treated for 5 days after basic assessment, and the use of experimental drugs and changes in clinical manifestations and laboratory examination were strictly recorded. The possible adverse hormonal reactions such as hyperglycemia, hypertension and gastrointestinal ulcer bleeding should be closely monitored and appropriate treatment measures should be taken in time. Subject will be allowed to terminate the test if necessary. Record and discuss similar events. The double blind principle is strictly observed during the experiment to ensure the authenticity and reliability of the experimental data.

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.

Primary outcomes:
measure: the rate of early treatment success
timeFrame: third day
Secondary outcomes:
Other outcomes:
Locations:
city: Baoding
country: China
facility: Baoding Children's Hospital
city: Beijing
country: China
facility: Beijing Children's Hospital
city: Beijing
country: China
facility: Beijing Fangshan District Health Care Hospital
Study officials:
affiliation: Beijing Children's Hospital
name: Baoping Xu
role: STUDY_DIRECTOR
References: