A study to assess the efficacy and safety of potassium clavulanate/amoxicillin in the treatment of children with acute bacterial sinusitis

Phase 1

• Conditions: Acute Bacterial Rhinosinusitis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-004907-22-Outside-EU/EEA
• Lead Sponsor: Medicines Development (Infectious Diseases)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-03
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Male or female children aged from 3 months to less than 15 years, 6 to less than 40 kg of body weight
who met criteria described below.
• Children with ABRS with inflammation as bacterial infection who has the following
symptoms/signs on the start date of study treatment or the day before.
1) Redness of the nasal mucosa
2) Purulent or mucopurulent nasal or postnasal discharge
3) Pathological shadow in the paranasal sinus on a radiogram (only for reference). Subject with a
surgical history should be excluded but subject with a pervious surgery more than 365 days
before and apparently preserved maxillary sinus mucosa or subject with a previous surgery of
nasal polypectomy more than 90 days before may be enrolled in the study.
• Children with ABRS classified as moderate or severe (Total score >= 4) based on the nasal
cavity findings and symptoms shown below:
Rhinnorhoea
Bad mood/productive cough
Nasal/postnasal discharge
Are the trial subjects under 18? yes
Number of subjects for this age range: 27
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject with a
surgical history should be excluded but subject with a pervious surgery more than 365 days
before and apparently preserved maxillary sinus mucosa or subject with a previous surgery of
nasal polypectomy more than 90 days before may be enrolled in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study was to assess clinical efficacy of CVA/AMPC 1:14 combination<br>[CVA/AMPC (1:14)] administered in children with acute bacterial rhinosinusitis (ABRS).;Secondary Objective: The secondary objectives of this study were to assess bacteriological efficacy and safety of<br>CVA/AMPC (1:14) administered in children with ABRS.;Primary end point(s): Clinical outcome at Test of Cure;Timepoint(s) of evaluation of this end point: Day 15

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy<br>1. Clinical outcome at End of Treatment<br>2. Bacteriological outcome<br>3. Severity assessment of symptoms and nasal cavity findings <br><br>Safety<br>1. All adverse events experienced<br>2. Clinical laboratory parameters (hematology and clinical chemistry) <br><br>Others<br>1. Overall acceptability of medication <br>2. Treatment compliance<br><br>;Timepoint(s) of evaluation of this end point: Efficacy<br>1. Day 8<br>2. Day 1 and 8<br>3. Day 1, 4, 8 and 15<br><br>Safety<br>1. From Day 1 to Day 15<br>2. Day 1 and 8<br><br>Others<br>1. Day 8<br>2. From Day 1 to 8