Overview

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

Status:
Not yet recruiting
Trial end date:
2023-05-20
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Amoxicillin-Potassium Clavulanate Combination
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