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Acute Bacterial Rhinosinusitis (ABRS) is a respiratory inflammation commonly seen in clinical practice, which has with respiratory symptoms including nasal congestion, rhinorrhoea, postnasal discharge and cough and is associated with headache, cheek pain, facial pressure and other conditions. The principal bacterial pathogens in causing ABRS include Streptococcus pneumoniae, Haemophilus influenzae and Moraxella (Branhamella) catarrhalis. These three bacteria account for approximately 90% of ABRS in children less than or equal to 5 years of age. Combination of Potassium Clavulanate (CVA) and Amoxicillin (AMPC) produces higher antibiotic activity against beta-lactamase-producing bacteria. The present study is designed to assess the clinical efficacy, bacteriological efficacy and safety of CVA/AMPC (1:14) administered in children aged from 3 months to less than 15 years with ABRS. It is an open-label study consisting of a 7-day treatment phase and a post-treatment follow-up phase for 7 to 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Each participant will take Potassium Clavulanate (CVA)/ Amoxicillin (AMPC) corresponding 6.4/90 mg/kg/day in two divided doses (every 12 hours) just before lactation or meal for 7 days depending on his/her body weight at the start of treatment (Day 1). The actual daily dose depends on the body weight of the participant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxicillin-Potassium Clavulanate Combination | Drug | The drug is available in two sachets (CVA/AMPC Dry Syrup 0.505 g and CVA/AMPC Dry Syrup 1.01 g). CVA/AMPC Dry Syrup 1.01 g sachet contains 42.9 mg of Potassium Clavulanate and 600 mg of Amoxicillin Hydrate. It is a white to yellowish white powder and has strawberry flavor and it is white to yellowish white suspension when it is suspended before use. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15) | 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. | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chiba | 272-0143 | Japan | |||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 117150 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15) | 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. | 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 | Posted | Number | Participants | Day 15 |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract 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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|
| Day 8 |
| 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) | 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. | Day 8 and Day 15 |
| Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15 | 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. | Baseline (BL), Day 4, Day 8, and Day 15 |
| Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8 | 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). | Day 8 |
| Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8) | 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. | Day 8 |
| Chiba |
| 279-0012 |
| Japan |
| GSK Investigational Site | Tokyo | 125-0052 | Japan |
For additional information about this study please refer to the GSK Clinical Study Register |
| 117150 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117150 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117150 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117150 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117150 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 117150 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| OG000 | 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). |
|
|
|
| Secondary | Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8) | 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. | PP Population | Posted | Number | Participants | Day 8 |
|
|
|
| Secondary | 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) | 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. | PP Population | Posted | Number | Participants | Day 8 and Day 15 |
|
|
|
| Secondary | Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15 | 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. | PP Population | Posted | Number | Participants | Baseline (BL), Day 4, Day 8, and Day 15 |
|
|
|
| Secondary | Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8 | 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). | 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 | Posted | Number | Participants | Day 8 |
|
|
|
| Secondary | Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8) | 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. | 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 | Posted | Number | Participants | Day 8 |
|
|
|
| 0 |
| 27 |
| 5 |
| 27 |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
|
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.
| D010038 | Otorhinolaryngologic Diseases |
| 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 |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Rhinorrhoea: Day 4, None |
|
| Rhinorrhoea: Day 4, M/SA |
|
| Rhinorrhoea: Day 4, M or S |
|
| Rhinorrhoea: Day 8, None |
|
| Rhinorrhoea: Day 8, M/SA |
|
| Rhinorrhoea: Day 8, M or S |
|
| Rhinorrhoea: Day 15, None |
|
| Rhinorrhoea: Day 15, M/SA |
|
| Rhinorrhoea: Day 15, M or S |
|
| Bad mood/productive cough: BL None |
|
| Bad mood/productive cough: BL, M/SA |
|
| Bad mood/productive cough: BL, M or S |
|
| Bad mood/productive cough: Day 4, None |
|
| Bad mood/productive cough: Day 4, M/SA |
|
| Bad mood/productive cough: Day 4, M or S |
|
| Bad mood/productive cough: Day 8, None |
|
| Bad mood/productive cough: Day 8, M/SA |
|
| Bad mood/productive cough: Day 8, M or S |
|
| Bad mood/productive cough: Day 15, None |
|
| Bad mood/productive cough: Day 15, M/SA |
|
| Bad mood/productive cough: Day 15, M or S |
|
| N/PD: BL, Serous |
|
| N/PD: BL, MU/SA |
|
| N/PD: BL, M/LA |
|
| N/PD: Day 4, Serous |
|
| N/PD: Day 4, MU/SA |
|
| N/PD: Day 4, M/LA |
|
| N/PD: Day 8, Serous |
|
| N/PD: Day 8, MU/SA |
|
| N/PD: Day 8, M/LA |
|
| N/PD: Day 15, Serous |
|
| N/PD: Day 15, MU/SA |
|
| N/PD: Day 15, M/LA |
|
| Title | Measurements |
|---|---|
|
| PenSuscStPn, P |
|
| Pen Intermediate (PenInt) StPn, E |
|
| PenIntStPn, P |
|
| Pen Resistant (PenR) StPn, E |
|
| PenRStPn, P |
|
| Moraxella (Branhamella) catarrhalis (MBC), E |
|
| MBC, P |
|
| MBC beta-lactamase (BL) positive, E |
|
| MBC BL positive, P |
|
| MBC BL negative (N), E |
|
| MBC BLN, P |
|
| Haemophilus influenzae (HI), E |
|
| HI, P |
|
| HI BLN ampicillin (A) susceptible (S), E |
|
| HI BLNAS, P |
|
| HI BLNA resistant (R), E |
|
| HI BLNAR, P |
|
| HI BL Producing (Pr) AR, E |
|
| HI BLPrAR, P |
|
| Staphylococcus aureus (Staph Ar), E |
|
| Staph Ar, P |
|
| Methicillin R Staph Ar, E |
|
| Methicillin R Staph Ar, P |
|
| Streptococcus pyogenes, E |
|
| Streptococcus pyogenes, P |
|
| Enterobacter species (sp), E |
|
| Enterobacter sp., P |
|
| Coagulase (Coag) NStaph, E |
|
| CoagNStaph, P |
|
| Corynebacterium sp., E |
|
| Corynebacterium sp., P |
|
| Streptococcus sp., E |
|
| Streptococcus sp., P |
|
| Pseudomonas aeruginosa, E |
|
| Pseudomonas aeruginosa, P |
|