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To evaluate the safety profile of 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 (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.
Amoxicillin-clavulanate potassium has been shown to be efficacious in eradicating causative pathogens in acute otitis media (AOM) with resulting high clinical cure rates at end-of-treatment (85%). However, relatively high rates (~25%) of clinically significant diarrhea have been reported, the occurrence of which has been directly related to the clavulanate potassium component of the drug combination. A reduced concentration of clavulanate potassium in the drug formulation would be expected to have an improved safety profile regarding the occurrence of diarrhea. This study will examine whether the concentration of the clavulanate potassium component of amoxicillin-clavulanate potassium could be reduced in the treatment of children 6 months through 23 months of age diagnosed with AOM using stringent criteria. A total of 75 participants (n=75) with AOM will receive amoxicillin-clavulanate potassium (600 mg/21.5 mg/5 mL; 28:1) administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days.
The primary outcome measure will be rates of clinically significant diarrhea and diaper dermatitis. These rates will be compared with the rate observed in our previous studies of AOM in children who received amoxicillin-clavulanate potassium (600 mg/42.9 mg/5 mL; 14:1) administered at 90/6.4 mg/kg/day in two divided doses for 10 days.
A subset of this group will have pharmacokinetic studies performed. Each participant that agrees will have a single blood draw (n=50). Investigators will analyze amoxicillin and clavulanate potassium in the blood samples using validated methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amoxicillin-clavulanate potassium | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-Clavulanate potassium | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Distribution of Participants Receiving Formulation 1 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. 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. | Day 1 of administration of amoxicillin-clavulanate until day 12. |
| The Distribution of Participants Receiving Formulation 2 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. | Day 1 of administration of amoxicillin-clavulanate until day 12. |
| The Distribution of Participants Receiving Formulation 1 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. 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. | Day 1 of administration of amoxicillin-clavulanate until day 12. |
| The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product |
| Measure | Description | Time Frame |
|---|---|---|
| The Distribution of Participants Receiving Formulation 1 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. 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nader Shaikh, MD, MPH | University of Pittsburgh School of Medicine; Children's Hospital of Pittsburgh of UPMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28438923 | Derived | Hoberman A, Paradise JL, Rockette HE, Jeong JH, Kearney DH, Bhatnagar S, Shope TR, Muniz G, Martin JM, Kurs-Lasky M, Haralam M, Pope MA, Nagg JP, Zhao W, Miah MK, Beumer J, Venkataramanan R, Shaikh N. Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media. Antimicrob Agents Chemother. 2017 Jun 27;61(7):e00238-17. doi: 10.1128/AAC.00238-17. Print 2017 Jul. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amoxicillin-clavulanate Potassium | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amoxicillin-clavulanate Potassium | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Distribution of Participants Receiving Formulation 1 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. 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 number of participants is equal to the number of children receiving formulation 1. | Posted | Count of Participants | Participants | Day 1 of administration of amoxicillin-clavulanate until day 12. |
|
Adverse event data were collected through the end-of-treatment visit. The mean day for this visit was 14.2.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amoxicillin-clavulanate Potassium | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Protocol defined diarrhea | Gastrointestinal disorders | Systematic Assessment | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nader Shaikh | University of Pittsburgh | 412-692-8111 | nader.shaikh@chp.edu |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
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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.. |
| Day 1 of administration of amoxicillin-clavulanate until day 12. |
| From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9. |
| The Distribution of Participants Receiving Formulation 2 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. | From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9. |
| 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 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. | Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5. |
| 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 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. | Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6. |
| The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1 | 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 end-of-treatment visit. The mean day for this visit was 14.9. |
| The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2 | 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 end-of-treatment visit. The mean day for this visit was 13.9. |
| Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1 | 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. | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
| Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2 | 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. | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
| Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1 | 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. | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
| Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2 | 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. | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was reported by the children's parents. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was reported by the children's parents. | Count of Participants | Participants |
|
| Maternal Education | Count of Participants | Participants |
|
| Type of Health Insurance | Type of health insurance relates to the child's insurance. | Count of Participants | Participants |
|
| Exposure to Other Children | Exposed to other children is defined as exposure to at least 3 children for at least 10 hours per week. | Count of Participants | Participants |
|
| Acute Otitis Media Severity of Symptoms (AOM-SOS) Score | 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. | Count of Participants | Participants |
|
| Mean AOM-SOS Score | 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. | Mean | Standard Deviation | AOM-SOS score |
|
| Laterality of Acute Otitis Media (AOM) | Count of Participants | Participants |
|
| Degree of Tympanic Membrane (TM) Bulging | 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, | Count of Participants | Participants |
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| Primary | The Distribution of Participants Receiving Formulation 2 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 number of participants is equal to the number of children receiving formulation 2. | Posted | Count of Participants | Participants | Day 1 of administration of amoxicillin-clavulanate until day 12. |
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| Primary | The Distribution of Participants Receiving Formulation 1 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. 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 number of participants is equal to the number of children receiving formulation 1. | Posted | Count of Participants | Participants | Day 1 of administration of amoxicillin-clavulanate until day 12. |
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| Primary | The Distribution of Participants Receiving Formulation 2 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 number of participants is equal to the number of children receiving formulation 2. | Posted | Count of Participants | Participants | Day 1 of administration of amoxicillin-clavulanate until day 12. |
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| Secondary | The Distribution of Participants Receiving Formulation 1 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. 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 number of participants is equal to the number of children receiving formulation 1 who had an end-of-treatment assessment at or before the day 12 visit. | Posted | Count of Participants | Participants | From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9. |
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| Secondary | The Distribution of Participants Receiving Formulation 2 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 number of participants is equal to the number of children receiving formulation 2 who had an end-of-treatment assessment at or before the day 12 visit. | Posted | Count of Participants | Participants | From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9. |
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| Secondary | 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 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 number of participants is equal to the number of children receiving formulation 1 who had a day 7 assessment. | Posted | Count of Participants | Participants | Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5. |
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| Secondary | 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 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 number of participants is equal to the number of children receiving formulation 2 who had a day 7 assessment. | Posted | Count of Participants | Participants | Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6. |
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| Secondary | The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1 | 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 number of participants is equal to the number of children receiving formulation 1 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | The end-of-treatment visit. The mean day for this visit was 14.9. |
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| Secondary | The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2 | 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 number of participants is equal to the number of children receiving formulation 2 whose parent or guardian completed a level of satisfaction questionnaire at the end-of-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | The end-of-treatment visit. The mean day for this visit was 13.9. |
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| Secondary | Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1 | 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. | The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/ml) | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
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| Secondary | Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2 | 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. | The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/ml) | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
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| Secondary | Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1 | 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. | The participants are the children receiving formulation 1 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
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| Secondary | Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2 | 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. | The participants are the children receiving formulation 2 whose parent or guardian agreed to a single blood draw after administration of a single dose of amoxicillin-clavulanate and who had an ensuing measure of plasma concentration. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/ml) | From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after. |
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|
| 0 |
| 112 |
| 0 |
| 112 |
| 38 |
| 112 |
|
| Diaper dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent. |
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Not provided
Not provided
Not provided
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
|
| 2.0 hours (approximate) |
|
|
| 3.0 hours (approximate) |
|
|
| 3.5 hours (approximate) |
|
|
| 4.0 hours (approximate) |
|
|
|
| 2.0 hours (approximate) |
|
|
| 2.5 hours (approximate) |
|
|
| 3.0 hours (approximate) |
|
|
| 3.5 hours (approximate) |
|
|
| 4.0 hours (approximate) |
|
|
|
| 2.0 hours (approximate) |
|
|
| 3.0 hours (approximate) |
|
|
| 3.5 hours (approximate) |
|
|
| 4.0 hours (approximate) |
|
|
|
| 2.0 hours (approximate) |
|
|
| 2.5 hours (approximate) |
|
|
| 3.0 hours (approximate) |
|
|
| 3.5 hours (approximate) |
|
|
| 4.0 hours (approximate) |
|
|