Clinical trial NCT05711017: The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children
Official title: The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Community-acquired Pneumonia
Keywords: Pediatric
community-acquired pneumonia
Huashibaidu granule
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in clinical symptom score from baseline on day 3
timeFrame: 3 days
Secondary outcomes:
measure: Anti-infective efficacy of Huashibaidu granule
timeFrame: 5 days
measure: time to symptom resolution
timeFrame: 5 days
measure: total effective rate
timeFrame: 5 days
measure: change on the number of different pathogens sequences
timeFrame: 5 days
measure: changes in cytokines
timeFrame: 5 days
measure: Duration of hospitalization
timeFrame: 5 days
measure: Rate of transition to severe pneumonia
timeFrame: 5 days
measure: Rate of transition to ICU
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yong Yin, PhD
role: PRINCIPAL_INVESTIGATOR
References: