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Infections, BacterialPhase 2NCT05340257

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

A Phase 2 study testing Augmentin ES in people with Infections, Bacterial, run by GlaxoSmithKline at 2 sites in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 months to 12 years
Conditions the study is for
Infections, Bacterial
What is being tested?
Augmentin ES
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesBrazil
Study dates
14 Oct 2023to 8 Jul 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • GSK Investigational Site

    Ribeirão Preto, São Paulo, 14051-140

  • GSK Investigational Site

    São Paulo, 1223001

Other trials in Brazil

About this study

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

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.

Being tested
Augmentin ES
Keywords
Amoxicillin, Clavulanic acid, Community Acquired Pneumonia, Acute Bacterial Rhinosinusitis, Pharmacokinetics, Safety, Clinical response, Augmentin ES
Medical subject headings
Bacterial Infections, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmentin ESDrug

    Amoxicillin and clavulanic acid in fixed dose combination will be administered

Study groups in NCT05340257
Study groupRoleWhat they receive
Participants with CAP and ABRSExperimentalNot described
Receives: Drug: Augmentin ES

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 10 days

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

    Measured: Up to 10 days

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

    Measured: Up to 10 days

  4. Clearance (CL) of amoxicillin and clavulanic acid combination

    Measured: Up to 10 days

  5. Volume of distribution (Vd) of amoxicillin and clavulanic acid combination

    Measured: Up to 10 days

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

    Measured: Up to 10 days

Secondary outcomes (3)

  1. Number of participants with treatment emergent adverse events (TEAE)

    Measured: Up to Day 14

  2. Number of participants achieving Primary Clinical Response

    Measured: Day 11 to Day 14

  3. Number of participants achieving Secondary Clinical response

    Measured: Day 22 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2022
  2. Study start14 Oct 2023 (estimated)
  3. Primary completion8 Jul 2024 (estimated)
  4. Study completion8 Jul 2024 (estimated)

Why it stopped: Business Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single arm study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05340257
Sponsor's protocol ID
215335
Status last verified
Mar 2025
First submitted
15 Apr 2022
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Augmentin ES in people with Infections, Bacterial, run by GlaxoSmithKline at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absorption rate constant (Ka) of amoxicillin and clavulanic acid combination (time frame: Up to 10 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05340257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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