Protracted Bacterial Bronchitis Clinical Trial
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:
1. 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.
2. The enrolled patients were randomly divided into high-dose (90mg/kg/d) and standard dose
(60mg/kg/d) amoxicillin clavulanate potassium treatment group.
3. Medical history data of enrolled patients and daily cough score data were collected.
4. Assess the cough remission rate within two weeks and recurrence rate within 6 months in
both groups.
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:
1. 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.
2. The enrolled patients were randomly divided into high-dose (90mg/kg/d) and routine dose
(60mg/kg/d) amoxicillin clavulanate potassium treatment group.
3. Medical history data of enrolled patients and daily cough score data were collected.
4. 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
1. 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.
2. 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
1. 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.
2. 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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06020716 -
Antibiotics, Microbiology and Immunology in Children With Chronic Wet Cough - the AMIC Study
|
Phase 4 |