Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric PBB

NCT04378231 | Unknown

• 1 other identifier: SAHoWMU-CR2018-06-121
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 3.Medical history data of enrolled patients and daily cough score data were collected.
4. 4.Assess the cough remission rate within two weeks and recurrence rate within 6 months in both groups.

Conditions

Protracted Bacterial Bronchitis

Outcome Measures

Primary Outcomes (1)

• 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.

  within two weeks of inclusion

Secondary Outcomes (2)

• the absolute change in VCD score

  within two weeks of inclusion

• the incidence of adverse events

  through their followup completion, an average of half year

Study Arms (2)

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.

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.

Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension

Interventions

Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension DRUG

dry suspension of amoxicillin clavulanate potassium

Also known as: Amoxicillin and Clavulanate Potassium for Suspension

high-dose group; standard dose group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with first-onset PBB
• Subjects and their guardians agree to participate in the study and sign an informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Amoxicillin; Clavulanic Acid; Suspensions

Intervention Hierarchy (Ancestors)

Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

Study Officials

• Hai-lin Zhang, MD

  Second Affiliated Hospital of Wenzhou Medical Universitiy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-guang Hu, MD., PhD.

CONTACT

08613968893780; topanthu@163.com

Hai-lin Zhang, MD., PhD.

CONTACT

08613587661971‬‬; zhlwz97@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: May 7, 2020
• Study Start: May 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share