Trial Outcomes & Findings for Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media (NCT NCT02630992)
NCT ID: NCT02630992
Last Updated: 2018-01-03
Results Overview
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.
COMPLETED
PHASE3
112 participants
Day 1 of administration of amoxicillin-clavulanate until day 12.
2018-01-03
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
112
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
Baseline characteristics by cohort
| Measure |
Amoxicillin-clavulanate Potassium
n=112 Participants
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)
|
|---|---|
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Age, Customized
6-11 months
|
59 Participants
n=39 Participants
|
|
Age, Customized
12-23 months
|
53 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
74 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=39 Participants
|
|
Maternal Education
Below high school graduate
|
7 Participants
n=39 Participants
|
|
Maternal Education
High school graduate or equivalent
|
80 Participants
n=39 Participants
|
|
Maternal Education
College graduate
|
24 Participants
n=39 Participants
|
|
Maternal Education
Unknown
|
1 Participants
n=39 Participants
|
|
Type of Health Insurance
Private
|
34 Participants
n=39 Participants
|
|
Type of Health Insurance
Public
|
78 Participants
n=39 Participants
|
|
Exposure to Other Children
No
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47 Participants
n=39 Participants
|
|
Exposure to Other Children
Yes
|
65 Participants
n=39 Participants
|
|
Acute Otitis Media Severity of Symptoms (AOM-SOS) Score
3-5
|
40 Participants
n=39 Participants
|
|
Acute Otitis Media Severity of Symptoms (AOM-SOS) Score
6-8
|
50 Participants
n=39 Participants
|
|
Acute Otitis Media Severity of Symptoms (AOM-SOS) Score
9-10
|
22 Participants
n=39 Participants
|
|
Mean AOM-SOS Score
|
6.4 AOM-SOS score
STANDARD_DEVIATION 2.0 • n=39 Participants
|
|
Laterality of Acute Otitis Media (AOM)
Unilateral
|
65 Participants
n=39 Participants
|
|
Laterality of Acute Otitis Media (AOM)
Bilateral
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47 Participants
n=39 Participants
|
|
Degree of Tympanic Membrane (TM) Bulging
Slight
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9 Participants
n=39 Participants
|
|
Degree of Tympanic Membrane (TM) Bulging
Moderate or marked
|
103 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.Population: The number of participants is equal to the number of children 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. 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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=40 Participants
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)
|
|---|---|
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The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product
PDD reported
|
10 Participants
|
|
The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product
PDD not reported
|
30 Participants
|
PRIMARY outcome
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.Population: The number of participants is equal to the number of children 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. 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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=72 Participants
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)
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|---|---|
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The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product
PDD reported
|
12 Participants
|
|
The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product
PDD not reported
|
60 Participants
|
PRIMARY outcome
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.Population: The number of participants is equal to the number of children 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. 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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=40 Participants
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)
|
|---|---|
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The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product
Diaper dermatitis reported
|
10 Participants
|
|
The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product
Diaper dermatitis not reported
|
30 Participants
|
PRIMARY outcome
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.Population: The number of participants is equal to the number of children 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. 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..
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=72 Participants
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)
|
|---|---|
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The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product
Diaper dermatitis reported
|
15 Participants
|
|
The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product
Diaper dermatitis not reported
|
57 Participants
|
SECONDARY outcome
Timeframe: From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 14.9.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=35 Participants
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)
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|---|---|
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The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit
Treatment failure
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4 Participants
|
|
The Distribution of Participants Receiving Formulation 1 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit
Clinical success
|
31 Participants
|
SECONDARY outcome
Timeframe: From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=64 Participants
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)
|
|---|---|
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The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit
Treatment failure
|
8 Participants
|
|
The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit
Clinical success
|
56 Participants
|
SECONDARY outcome
Timeframe: Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.5.Population: The number of participants is equal to the number of children receiving formulation 1 who had a day 7 assessment.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=34 Participants
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)
|
|---|---|
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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
Resolution of AOM and improvement of symptoms
|
23 Participants
|
|
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
No resolution of AOM or no improvement of symptoms
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 1 of administration of amoxicillin-clavulanate until the day 7 visit. The mean day for this visit was 7.6.Population: The number of participants is equal to the number of children receiving formulation 2 who had a day 7 assessment.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=62 Participants
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)
|
|---|---|
|
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
Resolution of AOM and improvement of symptoms
|
31 Participants
|
|
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
No resolution of AOM or no improvement of symptoms
|
31 Participants
|
SECONDARY outcome
Timeframe: The end-of-treatment visit. The mean day for this visit was 14.9.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=35 Participants
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)
|
|---|---|
|
The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1
|
4.69 units on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: The end-of-treatment visit. The mean day for this visit was 13.9.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=64 Participants
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)
|
|---|---|
|
The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2
|
4.75 units on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=15 Participants
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)
|
|---|---|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
3.5 hours (approximate)
|
9.78 micrograms per milliliter (mcg/ml)
Standard Deviation 0
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
4.0 hours (approximate)
|
7.39 micrograms per milliliter (mcg/ml)
Standard Deviation 8.33
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
0.5 hours (approximate)
|
14.36 micrograms per milliliter (mcg/ml)
Standard Deviation 10.07
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
1.5 hours (approximate)
|
15.3 micrograms per milliliter (mcg/ml)
Standard Deviation 0
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
2.0 hours (approximate)
|
11.42 micrograms per milliliter (mcg/ml)
Standard Deviation 5.00
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
3.0 hours (approximate)
|
8.07 micrograms per milliliter (mcg/ml)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=24 Participants
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)
|
|---|---|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
0.5 hours (approximate)
|
8.63 micrograms per milliliter (mcg/ml)
Standard Deviation 3.89
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
1.5 hours (approximate)
|
7.49 micrograms per milliliter (mcg/ml)
Standard Deviation 1.59
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
2.0 hours (approximate)
|
7.76 micrograms per milliliter (mcg/ml)
Standard Deviation 6.56
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
2.5 hours (approximate)
|
10.22 micrograms per milliliter (mcg/ml)
Standard Deviation 7.18
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
3.0 hours (approximate)
|
13.00 micrograms per milliliter (mcg/ml)
Standard Deviation 0.50
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
3.5 hours (approximate)
|
10.36 micrograms per milliliter (mcg/ml)
Standard Deviation 1.94
|
|
Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
4.0 hours (approximate)
|
8.52 micrograms per milliliter (mcg/ml)
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=15 Participants
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)
|
|---|---|
|
Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1
0.5 hours (approximate)
|
1047.67 nanograms per milliliter (ng/ml)
Standard Deviation 419.90
|
|
Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1
1.5 hours (approximate)
|
2050 nanograms per milliliter (ng/ml)
Standard Deviation 0
|
|
Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1
2.0 hours (approximate)
|
730.50 nanograms per milliliter (ng/ml)
Standard Deviation 442.93
|
|
Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1
3.0 hours (approximate)
|
338 nanograms per milliliter (ng/ml)
Standard Deviation 0
|
|
Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1
3.5 hours (approximate)
|
842 nanograms per milliliter (ng/ml)
Standard Deviation 0
|
|
Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1
4.0 hours (approximate)
|
313.80 nanograms per milliliter (ng/ml)
Standard Deviation 146.91
|
SECONDARY outcome
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.Population: 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.
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.
Outcome measures
| Measure |
Amoxicillin-clavulanate Potassium
n=23 Participants
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)
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|---|---|
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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
0.5 hours (approximate)
|
407 nanograms per milliliter (ng/ml)
Standard Deviation 335.47
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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
1.5 hours (approximate)
|
655.50 nanograms per milliliter (ng/ml)
Standard Deviation 20.5
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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
2.0 hours (approximate)
|
1125.33 nanograms per milliliter (ng/ml)
Standard Deviation 418.49
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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
2.5 hours (approximate)
|
660.16 nanograms per milliliter (ng/ml)
Standard Deviation 389.69
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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
3.0 hours (approximate)
|
986.95 nanograms per milliliter (ng/ml)
Standard Deviation 963.05
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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
3.5 hours (approximate)
|
866.00 nanograms per milliliter (ng/ml)
Standard Deviation 534.00
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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
4.0 hours (approximate)
|
555.50 nanograms per milliliter (ng/ml)
Standard Deviation 494.53
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Adverse Events
Amoxicillin-clavulanate Potassium
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amoxicillin-clavulanate Potassium
n=112 participants at risk
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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|---|---|
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Gastrointestinal disorders
Protocol defined diarrhea
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21.4%
24/112 • Number of events 24 • Adverse event data were collected through the end-of-treatment visit. The mean day for this visit was 14.2.
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Skin and subcutaneous tissue disorders
Diaper dermatitis
|
25.0%
28/112 • Number of events 28 • Adverse event data were collected through the end-of-treatment visit. The mean day for this visit was 14.2.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place