drugset / Trial / NCT04378231

Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric PBB

NCT04378231

RandomizedParallel-groupOpen-labelTreatment

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. 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.

Timeline

Start
2020-05
Primary completion
2021-12
Completion
2022-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 30 mg/kg Oral
Subject Amoxicillin Other / unclassified 45 mg/kg Oral
Subject Clavulanate Unknown Oral

Indications