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A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS

Primary Purpose

Infections, Bacterial

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Augmentin ES
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infections, Bacterial focused on measuring Amoxicillin, Clavulanic acid, Community Acquired Pneumonia, Acute Bacterial Rhinosinusitis, Pharmacokinetics, Safety, Clinical response, Augmentin ES

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol.
  • In accordance with regional/local laws and regulations,
  • a. the parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has
  • b.given written assent, if applicable, to participate in the study (for participants between 7 to 12 years)
  • Age: Participant must be aged greater than or equal to (>=) 3 months to 12 years, of either gender.
  • Participants who are otherwise healthy and presenting with suspected CAP.
  • For participants clinically suspected of CAP, at least 3 of the following 4 criteria are applicable:
  • a) History of productive cough and/or shortness of breath.
  • b)Fever greater than (>)38.5 degree Celsius (○C) (Axillary temperature)
  • c) Tachypnea as defined by Respiratory rate (RR) >= 50 breaths/minute in children up to 11 months RR >= 40 breaths/minute in children from 12 months onwards
  • d) Chest X-Ray with shadow or lobar condensation, unilateral or bilateral.

For participants of ABRS:

  • The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol.
  • In accordance with regional/local laws and regulations,
  • a..The parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has
  • b. given written assent, if applicable, to participate in the study (for participants between 7 to 12 years).
  • Age: Participant must be between >=3 months to 12 years of either gender.
  • Participants who are otherwise healthy and presenting with suspected ABRS.
  • For participants of clinically suspected ABRS, the participants would be eligible if any of the following 2 of the 3 criteria stated below are met:
  • a.Children with purulent nasal discharge or daytime productive cough (which may worsen at night) or both persisting for 10 days or more without evidence of improvement.
  • b. Fever > 38.3○C (Axillary temperature)
  • c. Double sickness defined as initial improvement of symptoms and further worsening/ deterioration after 5 days.

Exclusion Criteria:

  • Severe ABRS/CAP requiring hospitalization.
  • Currently receiving or has received more than one dose of systemic antibiotic therapy within one week prior to the initiation of the study.
  • A serious underlying disease as per clinician's judgment.
  • Human immunodeficiency virus (HIV) infection/or any other immunosuppressive condition
  • Pre-existing renal insufficiency (for example [e.g.], plasma creatinine > 1.5 times upper limit of normal range for age).
  • Pre-existing liver disease(s) and/or hepatic dysfunction.
  • Any pre-existing malignancy/any participants undergoing any kind of chemotherapy.
  • Evidence of leukopenia and/or thrombocytopenia.
  • History of previous hypersensitivity reaction to penicillins, cephalosporins or other Beta-lactam antibiotics.
  • History of amoxicillin-clavulanate associated cholestatic jaundice/hepatic dysfunction.
  • History of phenylketonuria or a known hypersensitivity to aspartame.
  • Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter bowel function.
  • Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter renal function like probenecid.
  • Participants who have chronic sinusitis (signs and symptoms lasting greater than 28 days prior to screening visit.
  • Significant abnormalities of the sinuses and any complications of ABRS.
  • Have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days).
  • Any other infection or condition, which necessitates use of a concomitant systemic antimicrobial.
  • History of infectious mononucleosis.
  • History of pseudomembranous colitis.
  • Participants that are on warfarin therapy.
  • Receipt of an investigational compound (non-food and drug administration [FDA] and non-Brazil National Health Surveillance Agency [ANVISA] approved) or device within the previous 30 days or five half-lives, whichever is longer, preceding the first dose of study intervention or during the study.
  • Participants with symptoms suggestive of active Coronavirus disease 2019 (COVID-19) infection (that is (i.e.), fever, cough, etc.)
  • Participants with known COVID-19 positive contacts within the past 14 days.
  • Female participants who have attained menarche

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Participants with CAP and ABRS

    Arm Description

    Outcomes

    Primary Outcome Measures

    Absorption rate constant (Ka) of amoxicillin and clavulanic acid combination
    Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination
    Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination
    Clearance (CL) of amoxicillin and clavulanic acid combination
    Volume of distribution (Vd) of amoxicillin and clavulanic acid combination
    Terminal half-life (t1/2) of amoxicillin and clavulanic acid combination

    Secondary Outcome Measures

    Number of participants with treatment emergent adverse events (TEAE)
    Number of participants achieving Primary Clinical Response
    Number of participants achieving Secondary Clinical response

    Full Information

    First Posted
    April 15, 2022
    Last Updated
    May 22, 2023
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05340257
    Brief Title
    A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS
    Official Title
    An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics and Safety of Augmentin Extra Strength (ES)-600 Suspension in Children Presenting With Community Acquired Pneumonia (CAP) and Acute Bacterial Rhinosinusitis (ABRS) in Brazil
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 23, 2023 (Anticipated)
    Primary Completion Date
    January 17, 2024 (Anticipated)
    Study Completion Date
    January 17, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the pharmacokinetics, safety or tolerability through treatment emergent adverse event (TEAE) and to explore primary and secondary clinical response of treatment with Augmentin ES in pediatric population presenting with CAP and ABRS in Brazil.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infections, Bacterial
    Keywords
    Amoxicillin, Clavulanic acid, Community Acquired Pneumonia, Acute Bacterial Rhinosinusitis, Pharmacokinetics, Safety, Clinical response, Augmentin ES

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    This is a single arm study
    Masking
    None (Open Label)
    Masking Description
    This is an open-label study
    Allocation
    N/A
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants with CAP and ABRS
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Augmentin ES
    Intervention Description
    Amoxicillin and clavulanic acid in fixed dose combination will be administered
    Primary Outcome Measure Information:
    Title
    Absorption rate constant (Ka) of amoxicillin and clavulanic acid combination
    Time Frame
    Up to 10 days
    Title
    Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination
    Time Frame
    Up to 10 days
    Title
    Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination
    Time Frame
    Up to 10 days
    Title
    Clearance (CL) of amoxicillin and clavulanic acid combination
    Time Frame
    Up to 10 days
    Title
    Volume of distribution (Vd) of amoxicillin and clavulanic acid combination
    Time Frame
    Up to 10 days
    Title
    Terminal half-life (t1/2) of amoxicillin and clavulanic acid combination
    Time Frame
    Up to 10 days
    Secondary Outcome Measure Information:
    Title
    Number of participants with treatment emergent adverse events (TEAE)
    Time Frame
    Up to Day 14
    Title
    Number of participants achieving Primary Clinical Response
    Time Frame
    Day 11 to Day 14
    Title
    Number of participants achieving Secondary Clinical response
    Time Frame
    Day 22 to Day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol. In accordance with regional/local laws and regulations, a. the parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has b.given written assent, if applicable, to participate in the study (for participants between 7 to 12 years) Age: Participant must be aged greater than or equal to (>=) 3 months to 12 years, of either gender. Participants who are otherwise healthy and presenting with suspected CAP. For participants clinically suspected of CAP, at least 3 of the following 4 criteria are applicable: a) History of productive cough and/or shortness of breath. b)Fever greater than (>)38.5 degree Celsius (○C) (Axillary temperature) c) Tachypnea as defined by Respiratory rate (RR) >= 50 breaths/minute in children up to 11 months RR >= 40 breaths/minute in children from 12 months onwards d) Chest X-Ray with shadow or lobar condensation, unilateral or bilateral. For participants of ABRS: The participant and/or parent(s)/legal guardian(s) are willing and able to comply with the study protocol. In accordance with regional/local laws and regulations, a..The parent(s)/legal guardian(s) has given signed informed, dated consent; and the participant has b. given written assent, if applicable, to participate in the study (for participants between 7 to 12 years). Age: Participant must be between >=3 months to 12 years of either gender. Participants who are otherwise healthy and presenting with suspected ABRS. For participants of clinically suspected ABRS, the participants would be eligible if any of the following 2 of the 3 criteria stated below are met: a.Children with purulent nasal discharge or daytime productive cough (which may worsen at night) or both persisting for 10 days or more without evidence of improvement. b. Fever > 38.3○C (Axillary temperature) c. Double sickness defined as initial improvement of symptoms and further worsening/ deterioration after 5 days. Exclusion Criteria: Severe ABRS/CAP requiring hospitalization. Currently receiving or has received more than one dose of systemic antibiotic therapy within one week prior to the initiation of the study. A serious underlying disease as per clinician's judgment. Human immunodeficiency virus (HIV) infection/or any other immunosuppressive condition Pre-existing renal insufficiency (for example [e.g.], plasma creatinine > 1.5 times upper limit of normal range for age). Pre-existing liver disease(s) and/or hepatic dysfunction. Any pre-existing malignancy/any participants undergoing any kind of chemotherapy. Evidence of leukopenia and/or thrombocytopenia. History of previous hypersensitivity reaction to penicillins, cephalosporins or other Beta-lactam antibiotics. History of amoxicillin-clavulanate associated cholestatic jaundice/hepatic dysfunction. History of phenylketonuria or a known hypersensitivity to aspartame. Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter bowel function. Received, within 48 hours of study entry, or is scheduled to receive during the study period, any medication which may alter renal function like probenecid. Participants who have chronic sinusitis (signs and symptoms lasting greater than 28 days prior to screening visit. Significant abnormalities of the sinuses and any complications of ABRS. Have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days). Any other infection or condition, which necessitates use of a concomitant systemic antimicrobial. History of infectious mononucleosis. History of pseudomembranous colitis. Participants that are on warfarin therapy. Receipt of an investigational compound (non-food and drug administration [FDA] and non-Brazil National Health Surveillance Agency [ANVISA] approved) or device within the previous 30 days or five half-lives, whichever is longer, preceding the first dose of study intervention or during the study. Participants with symptoms suggestive of active Coronavirus disease 2019 (COVID-19) infection (that is (i.e.), fever, cough, etc.) Participants with known COVID-19 positive contacts within the past 14 days. Female participants who have attained menarche
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    US GSK Clinical Trials Call Center
    Phone
    877-379-3718
    Email
    GSKClinicalSupportHD@gsk.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    EU GSK Clinical Trials Call Center
    Phone
    +44 (0) 20 89904466
    Email
    GSKClinicalSupportHD@gsk.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD for this study will be made available via the Clinical Study Data Request site.
    IPD Sharing Time Frame
    IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
    IPD Sharing Access Criteria
    Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

    Learn more about this trial

    A Pharmacokinetics and Safety Study of Augmentin ES-600 in Children With CAP and ABRS

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