Last updated: 11/07/2018 11:23:47
Study to assess the efficacy and safety of Potassium Clavulanate/Amoxicillin in children with Acute Bacterial Rhinosinusitis
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Open-Label Study To Assess The Efficacy And Safety Of Potassium Clavulanate/Amoxicillin (CVA/AMPC 1:14 combination) In The Treatment Of Children With Acute Bacterial Rhinosinusitis
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with a clinical outcome of "cure" at Test of Cure (TOC: Day 15)
Timeframe: Day 15
Secondary outcomes:
Number of participants with a clinical outcome of "cure" at the End of Treatment (EOT: Day 8)
Timeframe: 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)
Timeframe: 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
Timeframe: 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
Timeframe: Day 8
Number of participants (par.) with the specified bacteriological (bact.) outcome per participant at EOT (Day 8)
Timeframe: Day 8
Interventions:
Drug: Amoxicillin-Potassium Clavulanate Combination
Enrollment:
27
Observational study model:
Not applicable
Primary completion date:
2013-07-11
Time perspective:
Not applicable
Clinical publications:
Rinya Sugita , Shuichi Yamamoto , Hidekatsu Motoyama , Masao Yarita . Efficacy and Safety of Potassium Clavulanate/Amoxicillin (1:14) Dry Syrup in the Treatment of Children with Acute Bacterial Rhinosinusitis. Jpn J Antibiot. 2015;68(3):189-200.
Medical condition
Sinusitis, Acute
Product
amoxicillin, amoxicillin/clavulanic acid, clavulanic acid
Collaborators
Not applicable
Study date(s)
August 2013 to November 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
3 months - 15 years
Accepts healthy volunteers
No
- Child with ABRS with inflammation as bacterial infection who has the following symptoms/signs on the day of or the day before the first dose of the investigational product: Redness of the nasal mucosa; nasal or postnasal discharge is purulent or mucopurulent; Pathological shadow in the paranasal sinus on a radiogram (only for reference). Patient with surgical history should be excluded but patient with a pervious surgery more than 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy more than 90 days before may be enrolled in the study.
- Child with ABRS whose severity is classified as moderate or severe (total score >=4) based on the nasal cavity findings and symptoms.
- Severe infection that requires surgical treatment (e.g., child with systemic symptoms such as fever associated with swelling face, child with almost full nasal obstruction due to a large nasal polyp).
- Serious complication such as acute mastoiditis, facial palsy, bacterial meningitis, and brain tumor.
Inclusion and exclusion criteria
Inclusion criteria:
- Child with ABRS with inflammation as bacterial infection who has the following symptoms/signs on the day of or the day before the first dose of the investigational product: Redness of the nasal mucosa; nasal or postnasal discharge is purulent or mucopurulent; Pathological shadow in the paranasal sinus on a radiogram (only for reference). Patient with surgical history should be excluded but patient with a pervious surgery more than 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy more than 90 days before may be enrolled in the study.
- Child with ABRS whose severity is classified as moderate or severe (total score >=4) based on the nasal cavity findings and symptoms.
- Boy or girl aged >=3 months to <15 years.
- Body weight >=6 kilograms (kg) to <40 kg.
- Written informed consent has been obtained from the child’s legally acceptable representative. If the child is 12 years or older, the child him/herself should have also provided written informed consent. The investigator (or sub-investigator) should attempt to obtain written informed consent from the child him/herself as far as possible even if the child is less than 12 years of age.
Exclusion criteria:
- Severe infection that requires surgical treatment (e.g., child with systemic symptoms such as fever associated with swelling face, child with almost full nasal obstruction due to a large nasal polyp).
- Serious complication such as acute mastoiditis, facial palsy, bacterial meningitis, and brain tumor.
- Congenital disorder such as maxillofacial dysplasia.
- Need of concomitant use of other antibiotics.
- Serious underlying disease (e.g., cardiac disease, malignancy, juvenile diabetes).
- Concurrent infection associated with gastrointestinal symptoms (e.g., diarrhoea, vomiting) that may affect safety assessment.
- Known hypersensitivity to any component of CVA/AMPC or penicillin or cephem antibiotic, or past history of a serious adverse reaction possibly related to any of these agents.
- Infectious mononucleosis.
- Current hepatic impairment, or past history of jaundice or hepatic impairment due to any component of CVA/AMPC.
- Past or current renal impairment (e.g., serum creatinine >=1.5 × Upper Limit of Normal, creatinine clearance of less than 30 milliliter/liter [mL/L]).
- Past or current immune dysfunction or insufficiency, or use of immunosuppressive therapy.
- Need corticosteroid for systemic, eye drops or nasal drops.
- Phenylketonuria.
- Use of azithromycin within 14 days prior to the first dose of the investigational product.
- Use of any antibiotic within 7 days prior to the first dose of the investigational product.
- Current use or imperative use during the study period of probenecid or a tubular secretion inhibitor.
- Participation in another clinical study within 3 months prior to enrollment, or prospected participation in another clinical study during the period of this study.
- Girl with menstruation and childbearing potential, pregnant girl, lactating girl, or girl who is planning a pregnancy during the study period. A girl with childbearing potential may be enrolled in the study only if she is willing to use at least one of the following acceptable measures for contraception throughout the study period: Male partner sterilization prior to the girl’s entry into the study, and this male is the sole partner for that girl; Intrauterine device (IUD) (with documented annual failure rate estimate of <1%); Abstinence; Male condom combined with a female diaphragm, either with or without a vaginal spermicide.
- The legally acceptable representative is a minor.
- Child in care.
- History of alcohol or drug abuse.
- Relationship with the study medical institution: The investigator, sub-investigator, study collaborator, person employed by the investigator or the study medical institution, or their close relatives.
- Child whose participation in the study is considered inappropriate by the investigator (or sub-investigator).
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-07-11
Actual study completion date
2013-07-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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