Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 26 for:    "Sinusitis" | "Clavulanate"

Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01934231
Recruitment Status : Completed
First Posted : September 4, 2013
Results First Posted : July 1, 2014
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sinusitis, Acute
Intervention Drug: Amoxicillin-Potassium Clavulanate Combination
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 27
Completed 27
Not Completed 0
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
6.6  (2.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
11
  40.7%
Male
16
  59.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian - Japanese Heritage Number Analyzed 27 participants
27
1.Primary Outcome
Title Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15)
Hide Description 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.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Cure 23
Failure 3
Unable to Determine 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CVA/AMPC (1:14)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate of Cure
Estimated Value 88.5
Confidence Interval (2-Sided) 95%
69.85 to 97.55
Estimation Comments The estimated parameter represents the rate of cure, calculated as (number of participants with an outcome of "Cure"/number of participants analyzed) * 100.
2.Secondary Outcome
Title Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8)
Hide Description 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.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Cure 25
Failure 1
Unable to Determine 0
3.Secondary Outcome
Title 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)
Hide Description 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.
Time Frame Day 8 and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Cure 23
Failure 3
Unable to Determine 0
4.Secondary Outcome
Title Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
Hide Description 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.
Time Frame Baseline (BL), Day 4, Day 8, and Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: Participants
Rhinorrhoea: BL, None 0
Rhinorrhoea: BL, M/SA 5
Rhinorrhoea: BL, M or S 21
Rhinorrhoea: Day 4, None 7
Rhinorrhoea: Day 4, M/SA 16
Rhinorrhoea: Day 4, M or S 3
Rhinorrhoea: Day 8, None 13
Rhinorrhoea: Day 8, M/SA 13
Rhinorrhoea: Day 8, M or S 0
Rhinorrhoea: Day 15, None 18
Rhinorrhoea: Day 15, M/SA 8
Rhinorrhoea: Day 15, M or S 0
Bad mood/productive cough: BL None 4
Bad mood/productive cough: BL, M/SA 20
Bad mood/productive cough: BL, M or S 2
Bad mood/productive cough: Day 4, None 16
Bad mood/productive cough: Day 4, M/SA 10
Bad mood/productive cough: Day 4, M or S 0
Bad mood/productive cough: Day 8, None 21
Bad mood/productive cough: Day 8, M/SA 5
Bad mood/productive cough: Day 8, M or S 0
Bad mood/productive cough: Day 15, None 24
Bad mood/productive cough: Day 15, M/SA 2
Bad mood/productive cough: Day 15, M or S 0
N/PD: BL, Serous 0
N/PD: BL, MU/SA 6
N/PD: BL, M/LA 20
N/PD: Day 4, Serous 14
N/PD: Day 4, MU/SA 10
N/PD: Day 4, M/LA 2
N/PD: Day 8, Serous 22
N/PD: Day 8, MU/SA 4
N/PD: Day 8, M/LA 0
N/PD: Day 15, Serous 21
N/PD: Day 15, MU/SA 5
N/PD: Day 15, M/LA 0
5.Secondary Outcome
Title Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
Hide Description 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).
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Participants
Streptococcus pneumoniae (StPn), E 8
StPn, P 1
Penicillin Susceptible (PenSusc) StPn, E 7
PenSuscStPn, P 1
Pen Intermediate (PenInt) StPn, E 1
PenIntStPn, P 0
Pen Resistant (PenR) StPn, E 0
PenRStPn, P 0
Moraxella (Branhamella) catarrhalis (MBC), E 6
MBC, P 0
MBC beta-lactamase (BL) positive, E 6
MBC BL positive, P 0
MBC BL negative (N), E 0
MBC BLN, P 0
Haemophilus influenzae (HI), E 8
HI, P 6
HI BLN ampicillin (A) susceptible (S), E 8
HI BLNAS, P 2
HI BLNA resistant (R), E 0
HI BLNAR, P 3
HI BL Producing (Pr) AR, E 0
HI BLPrAR, P 1
Staphylococcus aureus (Staph Ar), E 5
Staph Ar, P 0
Methicillin R Staph Ar, E 0
Methicillin R Staph Ar, P 0
Streptococcus pyogenes, E 1
Streptococcus pyogenes, P 0
Enterobacter species (sp), E 1
Enterobacter sp., P 0
Coagulase (Coag) NStaph, E 3
CoagNStaph, P 0
Corynebacterium sp., E 1
Corynebacterium sp., P 0
Streptococcus sp., E 1
Streptococcus sp., P 0
Pseudomonas aeruginosa, E 0
Pseudomonas aeruginosa, P 0
6.Secondary Outcome
Title Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)
Hide Description 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.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Participants
Eradication 24
Persistence 0
Time Frame 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).
Adverse Event Reporting Description 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.
 
Arm/Group Title CVA/AMPC (1:14)
Hide Arm/Group Description 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).
All-Cause Mortality
CVA/AMPC (1:14)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CVA/AMPC (1:14)
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CVA/AMPC (1:14)
Affected / at Risk (%)
Total   5/27 (18.52%) 
Gastrointestinal disorders   
Diarrhoea  1  3/27 (11.11%) 
Nausea  1  2/27 (7.41%) 
Infections and infestations   
Otitis media  1  2/27 (7.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01934231     History of Changes
Other Study ID Numbers: 117150
First Submitted: August 29, 2013
First Posted: September 4, 2013
Results First Submitted: May 29, 2014
Results First Posted: July 1, 2014
Last Update Posted: July 11, 2017