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Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric PBB

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ClinicalTrials.gov Identifier: NCT04378231
Recruitment Status : Not yet recruiting
First Posted : May 7, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

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. 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.

Condition or disease Intervention/treatment Phase
Protracted Bacterial Bronchitis Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric Protracted Bacterial Bronchitis: a Randomized Controlled Study.
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Experimental: 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.
Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension
dry suspension of amoxicillin clavulanate potassium
Other Name: Amoxicillin and Clavulanate Potassium for Suspension

Experimental: 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.
Drug: Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension
dry suspension of amoxicillin clavulanate potassium
Other Name: Amoxicillin and Clavulanate Potassium for Suspension




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. the absolute change in VCD score [ Time Frame: within two weeks of inclusion ]
    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. the incidence of adverse events [ Time Frame: through their followup completion, an average of half year ]
    the incidence of any adverse event and severe adverse event



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04378231


Contacts
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Contact: Xiao-guang Hu, MD., PhD. 08613968893780 topanthu@163.com
Contact: Hai-lin Zhang, MD., PhD. 08613587661971‬‬ zhlwz97@hotmail.com

Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Investigators
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Principal Investigator: Hai-lin Zhang, MD Second Affiliated Hospital of Wenzhou Medical Universitiy
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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04378231    
Other Study ID Numbers: SAHoWMU-CR2018-06-121
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action