amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg/day in two divided doses for 10 days; oral, liquid (formulation 2)

Amoxicillin-clavulanate Potassium

Age, Customized

Sex: Female, Male

Ethnicity was reported by the children's parents.

Ethnicity (NIH/OMB)

Race was reported by the children's parents.

Race (NIH/OMB)

Maternal Education

Type of health insurance relates to the child's insurance.

Type of Health Insurance

Exposed to other children is defined as exposure to at least 3 children for at least 10 hours per week.

Exposure to Other Children

The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child's usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.

Acute Otitis Media Severity of Symptoms (AOM-SOS) Score

Mean AOM-SOS Score

Laterality of Acute Otitis Media (AOM)

If a child has unilateral AOM, the degree of bulging reflects the degree of bulging in the ear with AOM. If a child has bilateral AOM, the degree of bulging reflects the degree of bulging in the ear with the greater level of bulging,

Degree of Tympanic Membrane (TM) Bulging

Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.
Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.

The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product

Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.
Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.

The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product

Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.
Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.

The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product

Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.
Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product..

The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product

Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.
Treatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.

The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit

Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.
Treatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable.

The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit

Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.
An assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.
The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child's usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.

The Distribution of Participants Receiving Formulation 1 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit

Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.
An assessment of participants was conducted at the day 7 visit using the AOM-SOS scale.
The AOM-SOS scale measures five discrete items: tugging of ears, crying, irritability, difficulty sleeping, and fever. Parents are asked to rate these symptoms in comparison with the child's usual state, as "none," "a little," or "a lot," with corresponding scores of 0, 1, and 2. Thus, total scores range from 0 to 10, with higher scores indicating greater severity of symptoms.

The Distribution of Participants Receiving Formulation 2 Demonstrating Resolution of Acute Otitis Media (AOM) and Substantial Improvement of Symptoms That Would Allow Discontinuing Therapy at the Day 7 Visit

Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.
The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively.

The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1

Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.
The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively.

The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2

Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.
Plasma concentration of amoxicillin 45 mg/kg/dose was measured.
Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.

Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1

Participants treated with formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.
Plasma concentration of amoxicillin 40 mg/kg/dose was measured.
Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.

Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2

Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.
Plasma concentration of clavulanate 1.6 mg/kg/dose was measured.
Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.

Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1

Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.
Plasma concentration of clavulanate 1.425 mg/kg/dose was measured.
Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child.

Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2

Overall Study

Nader Shaikh

amoxicillin-clavulanate potassium (600 mg/221.5 mg/5 mL; 28:1) administered prior to February 25, 2016 at 90/3.2 mg/kg in two divided doses for 10 days; oral, liquid (formulation 1) or administered as of February 25, 2016 at 80/2.85 mg/kg in two divided doses for 10 days; oral, liquid (formulation 2)

otitis media/kalium

Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media

Guidelines for Acute Sinusitis

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