Upper Respiratory Tract InfectionEarly Phase 1NCT04479657
Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
A Early Phase 1 study testing QingFei Granule and Cefuroxime in people with Upper Respiratory Tract Infection and Bacterial Infection, run by Zhong Wang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Upper Respiratory Tract Infection, Bacterial Infection, Chinese Medicine
- What is being tested?
- QingFei Granule and Cefuroxime
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2020to Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongfang Hospital
Beijing, Beijing Municipality, 100078
Li-Qun Wu, Prof., 010-67689706
About this study
Official title: A Randomized Controlled Study of Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
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.
Read the detailed description
Upper respiratory tract infection is the most common respiratory disease in childhood, and the incidence rate accounts for more than 60% of pediatric outpatients, ranking first in pediatric diseases. At present, antibiotics are commonly used to treat children with upper respiratory tract infections. However, due to the large amount of clinical use of antibiotics in recent years, the resistance of various pathogens has become stronger and stronger, which has caused the majority of clinicians and researchers to turn their attention to traditional Chinese medicine. Qingfei Granule is composed of six common herbal medicines such as Schizonepeta (Jing-Jie),Radix Scutellariae (Huang-qin),Forsythia (Lian-Qiao), etc. After upper respiratory tract infections with bacterial infections, chills, fever, runny nose, red and sore throat may occur, and may be accompanied by mild cough, thin red tongue, yellow moss, floating pulse,which is considered as the exogenous wind-heat Zheng in Chinese medicine. 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
- Being tested
- QingFei Granule, Cefuroxime
- Medical subject headings
- Respiratory Tract Infections, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QingFei GranuleDrug
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.
CefuroximeDrug
30mg/kg/d,bid, used until to the normalization of blood routine。
| Study group | Role | What they receive |
|---|---|---|
| QingFei Granule+Cefuroxime group | Experimental | Cefuroxime：30mg/kg/d,bid QingFei Granule: tid Receives: Drug: QingFei Granule; Drug: Cefuroxime |
| Cefuroxime group | Active comparator | Cefuroxime：30mg/kg/d,bid Receives: Drug: Cefuroxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 0, Day 5
Secondary outcomes (7)
Clinical remission rate of disease
The clinical remission rate of disease is defined as: the main symptoms such as chills, fever, nasal congestion, runny nose, sore throat, cough, etc. alleviate or disappear. Upper respiratory tract infection symptom scale score decreased by more than 70% compared with baseline
Measured: Day 3,Day 5
Fever clearance time
record once every 4 to 8 h after treatment.
Measured: Up to Day 5
Treatment failure rate
Treatment failure is defined as: body temperature does not decrease for 3 consecutive days, and / or complicated by laryngitis, tracheobronchitis, pneumonia, myocarditis, and / or oral antibiotics are switched to intravenous antibiotics.
Measured: Up to Day 5
The incidence of the complications
complicated with laryngitis, tracheo-bronchitis, pneumonia, myocarditis and other complications
Measured: Up to Day 5
The usage of the ibuprofen
If the temperature is over 38.5℃ or the child feel unbearable discomfort, the child will be given with ibuprofen. The usage of the ibuprofen (including the usage times and detail amount will be recorded in the patients' dairy.
Measured: Up to Day 5
The usage of antibiotics (Cefuroxime)
The usage of Cefuroxime (including the usage times and detail amount will be recorded in the patients' dairy.
Measured: Up to Day 5
The normalization rate of the blood routine
Measured: Day 3, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start17 Oct 2020
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhong Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhong Wang, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479657
- Sponsor's protocol ID
- QFKL V3.0
- Status last verified
- Nov 2022
- First submitted
- 17 Jul 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Qingfei Granule for the Treatment of the Pediatric Acute Upper Respiratory Tract Infection With Bacterial Infection
- ClinicalTrials.gov ID
- NCT04479657
- Acronym / sponsor ID
- QFKL V3.0
- Conditions
- Upper Respiratory Tract Infection, Bacterial Infection, Chinese Medicine, Pediatric Acute Upper Respiratory Tract Infection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhong WangUniversity, hospital or other
- Study start
- 17 Oct 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Upper respiratory tract infection is the most common respiratory disease in childhood, and the incidence rate accounts for more than 60% of pediatric outpatients, ranking first in pediatric diseases. At present, antibiotics are commonly used to treat children with upper respiratory tract infections. However, due to the large amount of clinical use of antibiotics in recent years, the resistance of various pathogens has become stronger and stronger, which has caused the majority of clinicians and researchers to turn their attention to traditional Chinese medicine. Qingfei Granule is composed of six common herbal medicines such as Schizonepeta (Jing-Jie),Radix Scutellariae (Huang-qin),Forsythia (Lian-Qiao), etc. After upper respiratory tract infections with bacterial infections, chills, fever, runny nose, red and sore throat may occur, and may be accompanied by mild cough, thin red tongue, yellow moss, floating pulse,which is considered as the exogenous wind-heat Zheng in Chinese medicine. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QingFei Granule+Cefuroxime group | Experimental | Drug: QingFei Granule, Drug: CefuroximeCefuroxime：30mg/kg/d,bid QingFei Granule: tid |
| Cefuroxime group | Active comparator | Drug: CefuroximeCefuroxime：30mg/kg/d,bid |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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%;
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QingFei GranuleQingFei 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. | Drug | QingFei Granule+Cefuroxime group |
| Cefuroxime30mg/kg/d,bid, used until to the normalization of blood routine。 | Drug | Cefuroxime group, QingFei Granule+Cefuroxime group |
Primary outcome
Bacterial clearance
Time frame: 0, Day 5
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%
7 secondary outcomes
Clinical remission rate of disease
Time frame: Day 3,Day 5
Fever clearance time
Time frame: Up to Day 5
Treatment failure rate
Time frame: Up to Day 5
The incidence of the complications
Time frame: Up to Day 5
The usage of the ibuprofen
Time frame: Up to Day 5
The usage of antibiotics (Cefuroxime)
Time frame: Up to Day 5
The normalization rate of the blood routine
Time frame: Day 3, Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing QingFei Granule and Cefuroxime in people with Upper Respiratory Tract Infection and Bacterial Infection, run by Zhong Wang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu (8610-64093207, franlj1104@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial clearance (time frame: 0, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.