Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection

NCT04479657 | Unknown Early Phase 1

• 1 other identifier: QFKL V3.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to assess the antibacterial effect and symptoms-relief of Qingfei Granule in the patients with pediatric acute upper respiratory tract infection with bacterial infection.

Conditions

Upper Respiratory Tract Infection; Bacterial Infection; Chinese Medicine; Pediatric Acute Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Bacterial clearance

  The pharyngeal swabs were used for sampling, and the pharyngeal flora diversity amplicon sequencing was used to analyze the pharyngeal flora spectrum, and the change of pathogenic bacteria flora spectrum before and after treatment was analyzed to qualitatively judge the bacterial clearance. Calculate the bacterial clearance rate = (number of people removed / total number of people tested) × 100%

  0, Day 5

Secondary Outcomes (7)

• Clinical remission rate of disease

  Day 3,Day 5

• Fever clearance time

  Up to Day 5

• Treatment failure rate

  Up to Day 5

• The incidence of the complications

  Up to Day 5

• The usage of the ibuprofen

  Up to Day 5

Study Arms (2)

QingFei Granule+Cefuroxime group

EXPERIMENTAL

Cefuroxime：30mg/kg/d,bid QingFei Granule: tid

Drug: QingFei Granule; Drug: Cefuroxime

Cefuroxime group

ACTIVE COMPARATOR

Cefuroxime：30mg/kg/d,bid

Drug: Cefuroxime

Interventions

QingFei Granule DRUG

QingFei Granule is made from 6 commonly herbal medicine granule, such as Jingjie,Huang Qin,Lianqiao,etc. The children were given one package of QingFei Granule every day, dividing into 3 times to be administrated. It's be given for 5 days.

QingFei Granule+Cefuroxime group

Cefuroxime DRUG

30mg/kg/d,bid, used until to the normalization of blood routine。

Cefuroxime group; QingFei Granule+Cefuroxime group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis with the acute upper respiratory tract infection;
• Diagnosis with wind-heat Zheng according to Chinese medicine;
• Age: 5-14 years old;
• Body temperature ≥ 37.5 ℃;
• White blood cell count\> 12 × 10\^9 / L, and / or neutrophil ratio over than 70%;
• The informed consent process complies with the regulations, and the legal agent or the child (≥8 years old) jointly sign the informed consent

You may not qualify if:

• (1) Acute bacterial otitis media; (2) Patients with periodontitis or periodontal abscess (3) Candidiasis; (4) Patients with positive mycoplasma; (5) Taking antibiotics, anti-inflammatory drugs, and antihistamines; (6) Patients with severe comorbidities of heart, liver and kidney; (7) Other patients with acute infectious diseases and mycoplasma pneumoniae infections with symptoms similar to upper respiratory tract infection; (8) Children with a history of epilepsy or convulsions; (9) Patients with mental illness; (10) Those who are allergic to treatment drugs; (11) Participated in other clinical trials in the past month; (12) The investigator evaluates that it is not suitable to participate in this clinical trial or according to the investigator's judgment, who is likely to loss to follow-up.

Sponsors & Collaborators

• Zhong Wang: lead

Study Sites (1)

Dongfang Hospital

Beijing, Beijing Municipality, 100078, China

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections; Bacterial Infections

Interventions

Cefuroxime

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jun Liu

CONTACT

8610-64093207; franlj1104@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 21, 2020
• Study Start: October 17, 2020
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (1)