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

NCT05768204 | Unknown Phase 4

• 1 other identifier: BCH lung 020
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Severe Pneumonia

Keywords

Severe pneumonia; children; glucocorticoid; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Prednisolone Acetate

Placebo group

PLACEBO COMPARATOR

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

Other: placebo

Interventions

Prednisolone Acetate DRUG

The experimental group took prednisolone acetate which is a kind of oral glucocorticoid.

Also known as: Prednisolone

Experimental group

placebo OTHER

A placebo consistent in appearance with the prednisolone acetate.

Placebo group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• month-\< 18 years old.
• Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes).
• 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

You may not qualify if:

• Systemic corticosteroids have been used to treat pneumonia before admission.
• Use systemic glucocorticoids within 3 months before admission.
• Hospital-acquired pneumonia.
• 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.
• Unconscious, need endotracheal intubation, children admitted to ICU.
• Those who are allergic to the drugs or their preparation components involved in the study.
• Those with hormonal contraindications: hypertension, diabetes, active peptic ulcer, adrenal hyperfunction, corneal ulcer, increased intraocular pressure, severe psychosis.
• There is a current infection that is difficult to control with antibacterial drugs.
• Children who are participating in other clinical trials.
• The investigator believes that it is not suitable to participate in the study.

Sponsors & Collaborators

• Baoping XU: lead

Study Sites (3)

Baoding Children's Hospital

Baoding, China

RECRUITING

Beijing Children's Hospital

Beijing, China

RECRUITING

Beijing Fangshan District Health Care Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Pneumonia

Interventions

prednisolone acetate; Prednisolone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Baoping Xu

  Beijing Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Baoping Xu

CONTACT

13370115002; xubaopingbch@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: March 14, 2023
• Study Start: March 10, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)