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

Sponsor
Baoping XU (Other)
Overall Status
Recruiting
CT.gov ID
NCT05768204
Collaborator
(none)
160
3
2
32.8
53.3
1.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Prednisolone Acetate
  • Other: placebo
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Research on the Treatment of Severe Community-acquired Pneumonia in Children
Actual Study Start Date :
Mar 10, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. the rate of early treatment success [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baoding Children's Hospital Baoding China
    2 Beijing Children's Hospital Beijing China
    3 Beijing Fangshan District Health Care Hospital Beijing China

    Sponsors and Collaborators

    • Baoping XU

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baoping XU, Professor, Beijing Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT05768204
    Other Study ID Numbers:
    • BCH lung 020
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 14, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Baoping XU, Professor, Beijing Children's Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 14, 2023