MedTrace Logo

Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric PBB

NCT04378231 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-07

No results posted yet for this study

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.

Conditions

  • Protracted Bacterial Bronchitis

Interventions

DRUG

Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension

dry suspension of amoxicillin clavulanate potassium

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Hai-lin Zhang, MD · Second Affiliated Hospital of Wenzhou Medical Universitiy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2021-12-31
Completion
2022-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378231 on ClinicalTrials.gov