Clinical trial NCT01934231: Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sinusitis, Acute
Keywords: Acute bacterial rhinosinusitis
Amoxicilin
Infection
Potassium clavulanate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 27
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Primary outcomes:
measure: Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15)
timeFrame: Day 15
Secondary outcomes:
measure: Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8)
timeFrame: Day 8
measure: 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
measure: 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
measure: 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
measure: Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)
timeFrame: Day 8
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: