Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis
Condition: Sinusitis, Acute
MeSH terms: Sinusitis
Intervention: Amoxicillin-Potassium Clavulanate Combination
Intervention description: 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.
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 3 Months
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Acute bacterial rhinosinusitis; Amoxicilin; Infection; Potassium clavulanate

Summary:

      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.
    

Eligibility 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).