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

Severe Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768204
• Other study ID #: BCH lung 020
• Status: Recruiting
• Phase: Phase 4
• Start date: March 10, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2023
• Source: Beijing Children's Hospital
• Contact: Baoping Xu
• Phone: 13370115002
• Email: xubaopingbch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia
• Severe Pneumonia

Intervention

Drug:
• Prednisolone Acetate
The experimental group took prednisolone acetate which is a kind of oral glucocorticoid.

Other:
• placebo
A placebo consistent in appearance with the prednisolone acetate.

Locations

Country	Name	City	State
China	Baoding Children's Hospital	Baoding
China	Beijing Children's Hospital	Beijing
China	Beijing Fangshan District Health Care Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Baoping XU

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of early treatment success	temperature is normal, clinical manifestations are significantly improved, pulmonary signs are significantly improved or disappeared, and white blood cell\C reactive protein\procalcitonin returns to normal	third day