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

NCT05340257 | Withdrawn Phase 2

• 1 other identifier: 215335
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Infections, Bacterial

Keywords

Amoxicillin; Clavulanic acid; Community Acquired Pneumonia; Acute Bacterial Rhinosinusitis; Pharmacokinetics; Safety; Clinical response; Augmentin ES

Outcome Measures

Primary Outcomes (6)

• Absorption rate constant (Ka) of amoxicillin and clavulanic acid combination

  Up to 10 days

• Area under the serum concentration-time curve (AUC) of amoxicillin and clavulanic acid combination

  Up to 10 days

• Maximum serum concentration (Cmax) of amoxicillin and clavulanic acid combination

  Up to 10 days

• Clearance (CL) of amoxicillin and clavulanic acid combination

  Up to 10 days

• Volume of distribution (Vd) of amoxicillin and clavulanic acid combination

  Up to 10 days

• Terminal half-life (t1/2) of amoxicillin and clavulanic acid combination

  Up to 10 days

Secondary Outcomes (3)

• Number of participants with treatment emergent adverse events (TEAE)

  Up to Day 14

• Number of participants achieving Primary Clinical Response

  Day 11 to Day 14

• Number of participants achieving Secondary Clinical response

  Day 22 to Day 28

Study Arms (1)

Participants with CAP and ABRS

EXPERIMENTAL

Drug: Augmentin ES

Interventions

Augmentin ES DRUG

Amoxicillin and clavulanic acid in fixed dose combination will be administered

Participants with CAP and ABRS

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

GSK Investigational Site

São Paulo, 1223001, Brazil

Location

MeSH Terms

Conditions

Bacterial Infections; Community-Acquired Pneumonia

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single arm study

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: October 14, 2023
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

BR (2)