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

Inclusion Criteria:

• The participant and/or parent(s)/legal guardian(s) are willing and able to complywith 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 theparticipant has

• b.given written assent, if applicable, to participate in the study (for participantsbetween 7 to 12 years)

• Age: Participant must be aged greater than or equal to (>=) 3 months to 12 years, ofeither gender.

• Participants who are otherwise healthy and presenting with suspected CAP.

• For participants clinically suspected of CAP, at least 3 of the following 4 criteriaare 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 upto 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 complywith 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 theparticipant has

• b. given written assent, if applicable, to participate in the study (forparticipants 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 ifany of the following 2 of the 3 criteria stated below are met:

• a.Children with purulent nasal discharge or daytime productive cough (which mayworsen at night) or both persisting for 10 days or more without evidence ofimprovement.

• 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 antibiotictherapy 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 immunosuppressivecondition

• Pre-existing renal insufficiency (for example [e.g.], plasma creatinine > 1.5 timesupper 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 orother Beta-lactam antibiotics.

• History of amoxicillin-clavulanate associated cholestatic jaundice/hepaticdysfunction.

• History of phenylketonuria or a known hypersensitivity to aspartame.

• Received, within 48 hours of study entry, or is scheduled to receive during thestudy period, any medication which may alter bowel function.

• Received, within 48 hours of study entry, or is scheduled to receive during thestudy period, any medication which may alter renal function like probenecid.

• Participants who have chronic sinusitis (signs and symptoms lasting greater than 28days prior to screening visit.

• Significant abnormalities of the sinuses and any complications of ABRS.

• Have concurrent streptococcal pharyngitis or acute otitis media (as the standarddoses for both of these conditions is 10 days).

• Any other infection or condition, which necessitates use of a concomitant systemicantimicrobial.

• 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] andnon-Brazil National Health Surveillance Agency [ANVISA] approved) or device withinthe previous 30 days or five half-lives, whichever is longer, preceding the firstdose 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