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

NCT01934231 | Completed Phase 3 Results

• 1 other identifier: 117150
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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.

Conditions

Sinusitis, Acute

Keywords

Acute bacterial rhinosinusitis; Amoxicilin; Infection; Potassium clavulanate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8)

  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)

  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

  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

  Day 8

• Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)

  Day 8

Study Arms (1)

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.

Drug: Amoxicillin-Potassium Clavulanate Combination

Interventions

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.

Single arm

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Chiba, 272-0143, Japan

Location

GSK Investigational Site

Chiba, 279-0012, Japan

Location

GSK Investigational Site

Tokyo, 125-0052, Japan

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Sinusitis; Infections

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 4, 2013
• Study Start: August 30, 2013
• Primary Completion: November 7, 2013
• Study Completion: November 7, 2013
• Last Updated: July 11, 2017
• Results First Posted: July 1, 2014

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)