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

Primary Purpose

Severe Pneumonia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Prednisolone Acetate
placebo
Sponsored by
Baoping XU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Pneumonia focused on measuring Severe pneumonia, children, glucocorticoid, Randomized Controlled Trial

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1 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 Exclusion Criteria: 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.

Sites / Locations

  • Baoding Children's HospitalRecruiting
  • Beijing Children's HospitalRecruiting
  • Beijing Fangshan District Health Care HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 20, 2022
Last Updated
March 13, 2023
Sponsor
Baoping XU
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1. Study Identification

Unique Protocol Identification Number
NCT05768204
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Baoping XU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Pneumonia
Keywords
Severe pneumonia, children, glucocorticoid, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Prednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The same amount of placebo was taken orally as the trial for 5 days
Intervention Type
Drug
Intervention Name(s)
Prednisolone Acetate
Other Intervention Name(s)
Prednisolone
Intervention Description
The experimental group took prednisolone acetate which is a kind of oral glucocorticoid.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
A placebo consistent in appearance with the prednisolone acetate.
Primary Outcome Measure Information:
Title
the rate of early treatment success
Description
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
Time Frame
third day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baoping Xu
Phone
13370115002
Email
xubaopingbch@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoping Xu
Organizational Affiliation
Beijing Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Baoding Children's Hospital
City
Baoding
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
he zhang, master
Facility Name
Beijing Children's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yongkang wang, bachelor
Facility Name
Beijing Fangshan District Health Care Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianxin He, doctor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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