Phase 3
N=27
Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis
Sinusitis, Acute
Bottom Line
View on ClinicalTrials.gov: NCT01934231 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15) — 23; 3; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Amoxicillin-Potassium Clavulanate Combination (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Clinical Outcome of "Cure" at Test of Cure (TOC: Day 15) |
23; 3; 0 | — |
| SECONDARY Number of Participants With a Clinical Outcome of "Cure" at the End of Treatment (EOT: Day 8) |
25; 1; 0 | — |
| SECONDARY 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) |
23; 3; 0 | — |
| SECONDARY Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15 |
0; 5; 21; 7; 16; 3 | — |
| SECONDARY Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8 |
8; 1; 7; 1; 1; 0 | — |
| SECONDARY Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8) |
24; 0 | — |
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 =6 kilograms (kg) to =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).
Data sourced from ClinicalTrials.gov (NCT01934231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.