The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children

Community-acquired Pneumonia Clinical Trial

Official title:

The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children: a Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05711017
• Other study ID #: SCMCIRB- K2022168-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2022
• Source: Shanghai Children's Medical Center
• Contact: Yong Yin, PhD
• Phone: +8618930830705
• Email: yinyong9999[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to assess the efficacy and safety of Huashibaidu granule for the treatment of community-acquired pneumonia in children compared with placebo and to demonstrate the efficacy of Huashibaidu granule in improving clinical symptoms, removing pathogens, and shortening clinical course.

Description:

Subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as basic medical condition will be collected by investigators. The subjects will be randomly assigned to the Huashibaidu group and the placebo group.

During the study, patients will receive Huashibaidu granule or placebo two times a day for five consecutive days. Both groups of patients will receive conventional Western medical observation and symptomatic treatment, including empiric anti-infective therapy (antibiotics) and symptomatic treatment such as antipyretic, expectorant and asthmatic. Do not use other traditional Chinese medicines, proprietary Chinese medicines, and antiviral drugs. Expectorants other than Ambroxol cannot be used.

After enrollment, investigator will evaluate and score patients' clinical symptoms at day 0, 1, 2, 3, 4, 5. Detection of biomarkers associated with infection, screening of pathogen and imaging examination will be conducted at day 0. And pharyngeal swab will be collected by investigator for tNGS at day 0, 3, 5.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

1. Han nationality.

2. Diagnosed as community-associated pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)".

3. The first dose was given < 5 days from the onset of pneumonia (onset time is defined as the time of the first symptoms or signs of lower respiratory tract infection).

4. The guardian agrees to participate in the study and signs the informed consent form.

Exclusion Criteria:

1. The subject has severe respiratory distress, cyanosis, consciousness disorder, refusal to eat or dehydration.

2. The subject has chronic respiratory diseases, airway malformations, congenital heart disease, immune system diseases and other serious underlying diseases other than asthma.

3. The subject has moderate to severe persistent asthma or is in the acute asthma exacerbation.

4. The subject with influenza virus, pertussis, tuberculosis, fungi, and parasitic infections.

5. The subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 1.5 times higher than normal values in blood biochemical detection items, abnormal renal function, or troponin.

6. The subject with any other reason that investigators consider unsuitable to participate in this study.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Intervention

Drug:
• Huashibaidu granule
Subjects diagnosed as community-acquired pneumonia in children at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment day, day 0). The subject assigned to the Huashibaidu group will receive Huashibaidu granule two times a day for five consecutive days (day 1~5).
• Placebo
Subjects diagnosed as community-acquired pneumonia in children at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment day, day 0). The subject assigned to the placebo group will receive placebo two times a day for five consecutive days (day 1~5).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinical symptom score from baseline on day 3	Investigators will compare the change of clinical symptom score from baseline on day 3 in the Huashibaidu group to the placebo group. The main symptoms assessed by the investigators are body temperature (ear temperature), daytime cough, nocturnal cough, productive sputum, thick sputum, wheezing, and shortness of breath; Secondary symptoms include dry stools, decreased appetite, poor spirit, fatigue, and diarrhoea. Each symptom is assigned a score of 0, 1, 2, and 3 by investigators according to the symptoms from mild to severe.	3 days
Secondary	Anti-infective efficacy of Huashibaidu granule	Investigators will collect throat swabs from subjects for targeted next-generation sequencing (tNGS) detection to compare the change of pathogen sequence numbers from baseline on day 3 and day 5 in the Huashibaidu group to the placebo group.There are 95 target pathogens, including 31 DNA viruses, 38 RNA viruses, 10 gram-positive bacteria, 12 gram-negative bacteria, 1 mycoplasma and 3 chlamydia. For example, human adenovirus (23 species), human herpesvirus (5 species), enterovirus (6 species), coxsackievirus (5 species), human coronavirus (4 species), human respiratory syncytial virus (2 species) and so on.	5 days
Secondary	time to symptom resolution	Subjects will be scored daily for pneumonia symptom. And investigators will compare the time to pneumonia symptom resolution in the Huashibaidu group to the placebo group.	5 days
Secondary	total effective rate	Efficacy index (%) = {(symptom score before treatment - symptom score after treatment) / symptom score before treatment} * 100%. Significant efficiency: efficacy index greater than equal to or equal to 70%. Efficiency: efficacy index greater than or equal to 30% but less than 70%. Total effective rate = significant efficiency + effective rate.	5 days
Secondary	change on the number of different pathogens sequences	Investigators will record the change on the number of different pathogens sequences in the Huashibaidu group and the placebo group.	5 days
Secondary	changes in cytokines	Investigators will record the change in cytokines in the Huashibaidu group and the placebo group, which contain IL-1ß, IL-4, IL-5, IL-6, IL-8, IL-17a, IL-12, IL-13, TGF-ß1, IFN-a, IFN-ß, IFN-?, TNF-a, TNF-ß and ISG-15.	5 days
Secondary	Duration of hospitalization	Investigators will compare the duration of hospitalization in the Huashibaidu group to the placebo group.	5 days
Secondary	Rate of transition to severe pneumonia	Rate of transition to severe pneumonia = number of subjects who have turned severe pneumonia / total number of subjects in the Huashibaidu group or placebo group.	5 days
Secondary	Rate of transition to ICU	Rate of transition to ICU = number of subjects who have been transferred from the general ward to the ICU / total number of subjects in the Huashibaidu group or placebo group.	5 days