Protracted Bacterial BronchitisNCT04378231
Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric PBB
A study testing Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension in people with Protracted Bacterial Bronchitis, run by Second Affiliated Hospital of Wenzhou Medical University.
Trial summary
Chronic wet cough is one of the most common symptoms of respiratory diseases in children. Protracted bacterial bronchitis (protracted bacterial bronchitis, PBB) is the most common cause of chronic wet cough in children. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Protracted Bacterial Bronchitis
- What is being tested?
- Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Jul 2022
- Phase
- Interventional
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children diagnosed with first-onset PBB
- Subjects and their guardians agree to participate in the study and sign an informed consent
Who cannot join
- Seriously delayed development of the nervous system;
- With severe underlying diseases: such as severe neuromuscular diseases, immunodeficiency, malnutrition, heart diseases, congenital respiratory system malformation, and other diseases of the heart, brain, liver, kidney and blood system;
- Other diseases that can cause chronic wet cough, including chronic rhinitis, sinusitis, interstitial lung disease, and clinical suspicion of bronchiectasis;
- With poor compliance and expected difficulty in completing the study;
- Other conditions considered inappropriate by the researcher.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric Protracted Bacterial Bronchitis: a Randomized Controlled Study.
Chronic wet cough is one of the most common symptoms of respiratory diseases in children. Protracted bacterial bronchitis (protracted bacterial bronchitis, PBB) is the most common cause of chronic wet cough in children. Potassium amoxicillin clavulanate is the recommended drug for the treatment of PBB, but there is not enough evidence to date on the dose and course of treatment. investigate the efficacy of different doses of amoxicillin clavulanate sodium in the treatment of chronic bacterial bronchitis in children. The methods of this study are summarized as following:
- Screening cases of chronic wet cough in children aged 2 to 6 years old who came to our hospital for treatment. Those diagnosed as PBB were included in this study, after obtaining the written informed consent from their parents or guardians.
- The enrolled patients were randomly divided into high-dose (90mg/kg/d) and standard dose (60mg/kg/d) amoxicillin clavulanate potassium treatment group.
- Medical history data of enrolled patients and daily cough score data were collected.
- Assess the cough remission rate within two weeks and recurrence rate within 6 months in both groups.
Read the detailed description
Chronic cough is one of the common reasons for children seeking medical treatment. In children, chronic cough is associated with impaired quality of life, multiple doctor visits, and adverse effects from inappropriate use of medications. Protracted bacterial bronchitis (PBB) is the most common cause of chronic wet cough in children. Most PBB has a good prognosis, but the persistence of PBB can lead to chronic suppurative lung disease, bronchiectasis and chronic obstructive pneumonia. Therefore, PBB must be timely diagnosed, standardized treatment and strict monitoring to avoid the progression of bronchiectasis and chronic obstructive pulmonary disease.
As in children with chronic wet cough, H. influenzae was the most common pathogen cultured from children with PBB. The other commonly detected bacteria are Strep. pneumoniae and M. catarrhalis and while Staphylococcus aureus. Amoxicillin clavulanate is the most commonly recommended drug for the treatment of PBB, but there is no sufficient evidence for the dose and course of treatment. Therefore, the purpose of this study was to elucidate the optimal dose of amoxicillin clavulanate potassium in the treatment of PBB. It is expected that 100 cases will be included and divided into high-dose group and routine dose group. After grouping, the corresponding dose of amoxicillin clavulanate potassium dry suspension will be prescribed according to the grouping conditions. Patients in high-dose group will receive 90mg/kg/d and the regular dose was 60mg/kg/d, which were taken orally twice a day. Medical history data and daily cough score data of enrolled patients were collected to assess the cough remission rate and recurrence rate within 6 months in both groups.
The research content:
- Screening cases of chronic wet cough in children aged 2 to 6 years old who came to our hospital for treatment. Those diagnosed with PBB were included in this study after obtaining the written informed consent of their parents or guardians.
- The enrolled patients were randomly divided into high-dose (90mg/kg/d) and routine dose (60mg/kg/d) amoxicillin clavulanate potassium treatment group.
- Medical history data of enrolled patients and daily cough score data were collected.
- Assess the cough remission rate and recurrence rate within 6 months in both groups.
Study design A randomized controlled study for children with protracted bacterial bronchitis
Therapeutic regimens
- In high-dose group, patients take dry suspension of amoxicillin clavulanate potassium 45 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks.
- In standard dose group, patients take dry suspension of amoxicillin clavulanate potassium 30 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks.
Effect evaluation
- Major outcome measure: "cough remission" rate, defined as a more than 75% reduction in verbal category descriptive (VCD) cough score at the end of the study compared to the baseline score at enrollment, or cough cessation for more than 3 days during the study period. The basic score refers to the average VCD of the first two days (-1 and -2 days). The score at the end of the study was the mean score for the first two days (15,16 days) after the 14-day study period.
- Secondary outcome measures: the absolute change in VCD score and the incidence of adverse events during the study period.
Safety assessment Safety issues will be evaluated before the enrollment and during the follow-up. it mainly included the analysis of meaningful clinical symptoms and adverse events, and the comparison of laboratory tests before and after the treatment.
- Conditions
- Protracted Bacterial Bronchitis
- Being tested
- Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspensionDrug
Also called Amoxicillin and Clavulanate Potassium for Suspension
dry suspension of amoxicillin clavulanate potassium
| Study group | Role | What they receive |
|---|---|---|
| high-dose group | Experimental | patients take dry suspension of amoxicillin clavulanate potassium 45 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks. Receives: Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension |
| standard dose group | Experimental | patients take dry suspension of amoxicillin clavulanate potassium 30 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks. Receives: Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough remission rate
defined as a more than 75% reduction in VCD cough score at the end of the study compared to the baseline score at enrollment, or cough cessation for more than 3 days during the study period.
Measured: within two weeks of inclusion
Secondary outcomes (2)
the absolute change in VCD score
The basic score refers to the average VCD of the first two days (-1 and -2 days). The score at the end of the study was the mean score for the first two days (15,16 days) after the 14-day study period.
Measured: within two weeks of inclusion
the incidence of adverse events
the incidence of any adverse event and severe adverse event
Measured: through their followup completion, an average of half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study startMay 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protracted Bacterial BronchitisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hai-lin Zhang, MD, Principal investigator, Second Affiliated Hospital of Wenzhou Medical Universitiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378231
- Sponsor's protocol ID
- SAHoWMU-CR2018-06-121
- Status last verified
- May 2020
- First submitted
- 23 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric Protracted Bacterial Bronchitis: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04378231
- Acronym / sponsor ID
- SAHoWMU-CR2018-06-121
- Conditions
- Protracted Bacterial Bronchitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 7 May 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.
Chronic wet cough is one of the most common symptoms of respiratory diseases in children. Protracted bacterial bronchitis (protracted bacterial bronchitis, PBB) is the most common cause of chronic wet cough in children. Potassium amoxicillin clavulanate is the recommended drug for the treatment of PBB, but there is not enough evidence to date on the dose and course of treatment. investigate the efficacy of different doses of amoxicillin clavulanate sodium in the treatment of chronic bacterial bronchitis in children. The methods of this study are summarized as following:
- Screening cases of chronic wet cough in children aged 2 to 6 years old who came to our hospital for treatment. Those diagnosed as PBB were included in this study, after obtaining the written informed consent from their parents or guardians.
- The enrolled patients were randomly divided into high-dose (90mg/kg/d) and standard dose (60mg/kg/d) amoxicillin clavulanate potassium treatment group.
- Medical history data of enrolled patients and daily cough score data were collected.
- Assess the cough remission rate within two weeks and recurrence rate within 6 months in both groups.
Detailed description
Chronic cough is one of the common reasons for children seeking medical treatment. In children, chronic cough is associated with impaired quality of life, multiple doctor visits, and adverse effects from inappropriate use of medications. Protracted bacterial bronchitis (PBB) is the most common cause of chronic wet cough in children. Most PBB has a good prognosis, but the persistence of PBB can lead to chronic suppurative lung disease, bronchiectasis and chronic obstructive pneumonia. Therefore, PBB must be timely diagnosed, standardized treatment and strict monitoring to avoid the progression of bronchiectasis and chronic obstructive pulmonary disease.
As in children with chronic wet cough, H. influenzae was the most common pathogen cultured from children with PBB. The other commonly detected bacteria are Strep. pneumoniae and M. catarrhalis and while Staphylococcus aureus. Amoxicillin clavulanate is the most commonly recommended drug for the treatment of PBB, but there is no sufficient evidence for the dose and course of treatment. Therefore, the purpose of this study was to elucidate the optimal dose of amoxicillin clavulanate potassium in the treatment of PBB. It is expected that 100 cases will be included and divided into high-dose group and routine dose group. After grouping, the corresponding dose of amoxicillin clavulanate potassium dry suspension will be prescribed according to the grouping conditions. Patients in high-dose group will receive 90mg/kg/d and the regular dose was 60mg/kg/d, which were taken orally twice a day. Medical history data and daily cough score data of enrolled patients were collected to assess the cough remission rate and recurrence rate within 6 months in both groups.
The research content:
- Screening cases of chronic wet cough in children aged 2 to 6 years old who came to our hospital for treatment. Those diagnosed with PBB were included in this study after obtaining the written informed consent of their parents or guardians.
- The enrolled patients were randomly divided into high-dose (90mg/kg/d) and routine dose (60mg/kg/d) amoxicillin clavulanate potassium treatment group.
- Medical history data of enrolled patients and daily cough score data were collected.
- Assess the cough remission rate and recurrence rate within 6 months in both groups.
Study design A randomized controlled study for children with protracted bacterial bronchitis
Therapeutic regimens
- In high-dose group, patients take dry suspension of amoxicillin clavulanate potassium 45 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks.
- In standard dose group, patients take dry suspension of amoxicillin clavulanate potassium 30 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks.
Effect evaluation
- Major outcome measure: "cough remission" rate, defined as a more than 75% reduction in verbal category descriptive (VCD) cough score at the end of the study compared to the baseline score at enrollment, or cough cessation for more than 3 days during the study period. The basic score refers to the average VCD of the first two days (-1 and -2 days). The score at the end of the study was the mean score for the first two days (15,16 days) after the 14-day study period.
- Secondary outcome measures: the absolute change in VCD score and the incidence of adverse events during the study period.
Safety assessment Safety issues will be evaluated before the enrollment and during the follow-up. it mainly included the analysis of meaningful clinical symptoms and adverse events, and the comparison of laboratory tests before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-dose group | Experimental | Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspensionpatients take dry suspension of amoxicillin clavulanate potassium 45 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks. |
| standard dose group | Experimental | Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspensionpatients take dry suspension of amoxicillin clavulanate potassium 30 mg/kg/ time (amoxicillin) orally twice a day, total daily dose not exceeding 2 g, and the course of treatment is two weeks. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children diagnosed with first-onset PBB
- Subjects and their guardians agree to participate in the study and sign an informed consent
Key exclusion criteria (5 listed)
- Seriously delayed development of the nervous system;
- With severe underlying diseases: such as severe neuromuscular diseases, immunodeficiency, malnutrition, heart diseases, congenital respiratory system malformation, and other diseases of the heart, brain, liver, kidney and blood system;
- Other diseases that can cause chronic wet cough, including chronic rhinitis, sinusitis, interstitial lung disease, and clinical suspicion of bronchiectasis;
- With poor compliance and expected difficulty in completing the study;
- Other conditions considered inappropriate by the researcher.
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 |
|---|---|---|
| Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspensionAlso: Amoxicillin and Clavulanate Potassium for Suspensiondry suspension of amoxicillin clavulanate potassium | Drug | high-dose group, standard dose group |
Primary outcome
cough remission rate
Time frame: within two weeks of inclusion
defined as a more than 75% reduction in VCD cough score at the end of the study compared to the baseline score at enrollment, or cough cessation for more than 3 days during the study period.
2 secondary outcomes
the absolute change in VCD score
Time frame: within two weeks of inclusion
the incidence of adverse events
Time frame: through their followup completion, an average of half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: No
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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.
Hai-lin Zhang, MD principal investigator
Second Affiliated Hospital of Wenzhou Medical Universitiy
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension in people with Protracted Bacterial Bronchitis, run by Second Affiliated Hospital of Wenzhou Medical University.
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 2 inclusion and 5 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Xiao-guang Hu, MD., PhD. (08613968893780, topanthu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough remission rate (time frame: within two weeks of inclusion). 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 7 May 2020.