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

March 13, 2023 updated by: Baoping XU
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Baoding, China
        • Recruiting
        • Baoding children's hospital
        • Contact:
          • he zhang, master
      • Beijing, China
        • Recruiting
        • Beijing Children's Hospital
        • Contact:
          • yongkang wang, bachelor
      • Beijing, China
        • Recruiting
        • Beijing Fangshan District Health Care Hospital
        • Contact:
          • jianxin He, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Prednisolone, oral, 2 mg/kg.d (maximum dose 60 mg/day), two or three times a day , 5 days.
Drug: Prednisolone Acetate
The experimental group took prednisolone acetate which is a kind of oral glucocorticoid.
Other Names:
  • Prednisolone
Placebo Comparator: Placebo group
The same amount of placebo was taken orally as the trial for 5 days
Other: placebo
A placebo consistent in appearance with the prednisolone acetate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of early treatment success
Time Frame: third day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baoping XU

Investigators

  • Study Director: Baoping Xu, Beijing Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCH lung 020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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