Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis (NCT NCT01934231)
NCT ID: NCT01934231
Last Updated: 2017-07-11
Results Overview
Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at TOC (Day 15) on the basis of the following criteria: "Cure" is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation.
COMPLETED
PHASE3
27 participants
Day 15
2017-07-11
Participant Flow
Participant milestones
| Measure |
CVA/AMPC (1:14)
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
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|---|---|
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Overall Study
STARTED
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27
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Overall Study
COMPLETED
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27
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis
Baseline characteristics by cohort
| Measure |
CVA/AMPC (1:14)
n=27 Participants
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
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|---|---|
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Age, Continuous
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6.6 Years
STANDARD_DEVIATION 2.42 • n=5 Participants
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Sex: Female, Male
Female
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11 Participants
n=5 Participants
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Sex: Female, Male
Male
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16 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian - Japanese Heritage
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27 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 15Population: Per Protocol (PP) Population: all participants randomized to treatment who received the study drug for at least the first 3 days of study treatment in the Treatment Period and had evaluable data on both Day 8 and Day 15 with treatment compliance between 80% and 100% and no major protocol deviations
Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at TOC (Day 15) on the basis of the following criteria: "Cure" is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation.
Outcome measures
| Measure |
CVA/AMPC (1:14)
n=26 Participants
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
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|---|---|
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Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15)
Cure
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23 Participants
|
|
Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15)
Failure
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3 Participants
|
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Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15)
Unable to Determine
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0 Participants
|
SECONDARY outcome
Timeframe: Day 8Population: PP Population
Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) on the basis of the following criteria: "Cure" is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation.
Outcome measures
| Measure |
CVA/AMPC (1:14)
n=26 Participants
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
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Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8)
Cure
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25 Participants
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Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8)
Failure
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1 Participants
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Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8)
Unable to Determine
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0 Participants
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SECONDARY outcome
Timeframe: Day 8 and Day 15Population: PP Population
Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) and TOC (Day 15) on the basis of the following criteria: "Cure" is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation. In order to be categorized as "cure," participants had to meet the criteria for "cure" at both Day 8 and Day 15.
Outcome measures
| Measure |
CVA/AMPC (1:14)
n=26 Participants
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
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Number of Participants With a Clinical Outcome of "Cure" at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)
Cure
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23 Participants
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Number of Participants With a Clinical Outcome of "Cure" at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)
Failure
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3 Participants
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Number of Participants With a Clinical Outcome of "Cure" at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)
Unable to Determine
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0 Participants
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SECONDARY outcome
Timeframe: Baseline (BL), Day 4, Day 8, and Day 15Population: PP Population
The investigator (or sub-investigator) categorized the severity of symptoms such as rhinorrhoea and bad mood/productive cough as none, mild/small amount (M/SA), or moderate or severe (M or S). For the nasal cavity finding of nasal/postnasal discharge (N/PD) the categozation was serous \[containing serum\]), mucopurulent (MU/SA \[containing both mucus and pus\]), and moderate or larger amount (M/LA). In cases in which both sides of the nasal cavity were affected and there was no difference in severity between the sides, the right-side results were recorded. If there was a difference in severity, the more severe-side results were recorded.
Outcome measures
| Measure |
CVA/AMPC (1:14)
n=26 Participants
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
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|---|---|
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: BL, None
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0 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: BL, M/SA
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5 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: BL, M or S
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21 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 4, None
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7 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 4, M/SA
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16 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 4, M or S
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3 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 8, None
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13 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 8, M/SA
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13 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 8, M or S
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0 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 15, None
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18 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 15, M/SA
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8 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Rhinorrhoea: Day 15, M or S
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0 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: BL None
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4 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: BL, M/SA
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20 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: BL, M or S
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2 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 4, None
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16 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 4, M/SA
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10 Participants
|
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 4, M or S
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0 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 8, None
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21 Participants
|
|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 8, M/SA
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5 Participants
|
|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 8, M or S
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0 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 15, None
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24 Participants
|
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 15, M/SA
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2 Participants
|
|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Bad mood/productive cough: Day 15, M or S
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0 Participants
|
|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: BL, Serous
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0 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: BL, MU/SA
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6 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: BL, M/LA
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20 Participants
|
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 4, Serous
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14 Participants
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 4, MU/SA
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10 Participants
|
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 4, M/LA
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2 Participants
|
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 8, Serous
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22 Participants
|
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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 8, MU/SA
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4 Participants
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|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 8, M/LA
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0 Participants
|
|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 15, Serous
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21 Participants
|
|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 15, MU/SA
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5 Participants
|
|
Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
N/PD: Day 15, M/LA
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0 Participants
|
SECONDARY outcome
Timeframe: Day 8Population: Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as "Unable to determine" for the bacteriological outcome and who had no identified pathogen at Day 1
The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each path. If the same pathogen was not detected at the EOT, this pathogen was classified as "eradication" (E). If the same pathogen was detected at the EOT, this pathogen was classified as "persistence" (P).
Outcome measures
| Measure |
CVA/AMPC (1:14)
n=24 Participants
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
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|---|---|
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Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Streptococcus pyogenes, E
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1 Participants
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Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Streptococcus pneumoniae (StPn), E
|
8 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
StPn, P
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1 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Penicillin Susceptible (PenSusc) StPn, E
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7 Participants
|
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Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
PenSuscStPn, P
|
1 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Pen Intermediate (PenInt) StPn, E
|
1 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
PenIntStPn, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Pen Resistant (PenR) StPn, E
|
0 Participants
|
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Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
PenRStPn, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Moraxella (Branhamella) catarrhalis (MBC), E
|
6 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
MBC, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
MBC beta-lactamase (BL) positive, E
|
6 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
MBC BL positive, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
MBC BL negative (N), E
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
MBC BLN, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Haemophilus influenzae (HI), E
|
8 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
HI, P
|
6 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
HI BLN ampicillin (A) susceptible (S), E
|
8 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
HI BLNAS, P
|
2 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
HI BLNA resistant (R), E
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
HI BLNAR, P
|
3 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
HI BL Producing (Pr) AR, E
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
HI BLPrAR, P
|
1 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Staphylococcus aureus (Staph Ar), E
|
5 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Staph Ar, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Methicillin R Staph Ar, E
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Methicillin R Staph Ar, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Streptococcus pyogenes, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Enterobacter species (sp), E
|
1 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Enterobacter sp., P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Coagulase (Coag) NStaph, E
|
3 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
CoagNStaph, P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Corynebacterium sp., E
|
1 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Corynebacterium sp., P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Streptococcus sp., E
|
1 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Streptococcus sp., P
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Pseudomonas aeruginosa, E
|
0 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Pseudomonas aeruginosa, P
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 8Population: Bacteriology PP Population: all participants in the PP Population, excluding the participants who were classified as "Unable to determine" for the bacteriological outcome and who had no identified pathogen at Day 1
The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each par. using the following classification: Bact. eradication (erad.), presumed bact. erad. and colonization were categorized as erad. Bact. persistence (pers.), presumed bact. pers. and superinfection were categorized as pers. Bact. erad. elimination of the pathogen (path.) after trt; presumed bact. erad.-resolution of signs/symptoms (s/s) after trt; colonization-resolution of s/s but initial path. still recovered from sample; bact. pers.-no improvement in s/s and initial path. was recovered from sample; presumed bact. pers.-no improvement in s/s and isolation of initial path. was impossible/not performed; superinfection-initial path. was eradicated but a new path. was recovered; unable to determine-bact. test could not be performed.
Outcome measures
| Measure |
CVA/AMPC (1:14)
n=24 Participants
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
|
|---|---|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)
Eradication
|
24 Participants
|
|
Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)
Persistence
|
0 Participants
|
Adverse Events
CVA/AMPC (1:14)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CVA/AMPC (1:14)
n=27 participants at risk
Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
3/27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to Study Day 22).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to Study Day 22).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
|
|
Infections and infestations
Otitis media
|
7.4%
2/27 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to Study Day 22).
SAEs and non-serious AEs were reported for members of the Safety Population, comprised of all participants randomized to treatment who received at least one dose of study medication.
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Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER