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

Baoping XU

Status and phase: Enrolling; Phase 4

Conditions: Severe Pneumonia

Treatments: Drug: Prednisolone Acetate; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05768204

BCH lung 020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

Prednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days.

Treatment:

Drug: Prednisolone Acetate

Placebo group

Placebo Comparator group

Description:

The same amount of placebo was taken orally as the trial for 5 days

Treatment:

Other: placebo