A multicenter, open-label study to assess the efficacy and safety of potassium clavulanate/amoxicillin(CVA/AMPC 1:14 combination) in the treatment of [Japanese] children with acute bacterial rhinosinusitis

Medicines Development (Infectious Diseases)0 个研究点目标入组 27 人开始时间: 2016年8月3日最近更新: 2016年8月8日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Medicines Development (Infectious Diseases)