EUCTR2021-004143-24-ES进行中（未招募）1 期
A Phase III, Multicenter, Randomized, Controlled, Open-label, Non-inferiority to Evaluate the Safety and Efficacy of Amoxicillin Ambulatory Short Treatment in Children with Acute Streptococcal Pharyngitis. - Short Treatment with Amoxicillin in Children with Acute Streptococcal Pharyngitis
Hospital Universitario Niño Jesus0 个研究点目标入组 710 人开始时间: 2022年3月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 710
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and female patients 2-17 (inclusive) years of age.
- •New diagnosis of acute streptococcal pharyngitis confirmed microbiologically by rapid antigen test with onset of symptoms not exceeding 72 hours before the start of study treatment.
- •McIsaac scale equal or greater than 2 points as long as there is fever =38ºC.
- •Voluntarily signed informed consent obtained from parents or legal guardians and assent in patients 12 years of age or older before any trial-related procedures are performed
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 710
- •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
排除标准
- •To be receiving antibiotic treatment whose spectrum of action includes Streptococcus pyogenes (penicillin, amoxicillin, amoxicillin clavulanate, macrolides or first, second or third generation cephalosporins.
- •To have received treatment with any of the following medications in the previous 48 hours: probenecid, allopurinol, tetracyclines, oral anticoagulants or methotrexate.
- •Recurrent streptococcal pharyngitis: seven or more episodes of acute streptococcal pharyngitis per year in the last year, five or more episodes per year in the last two years, or three or more episodes per year in the last three years. In addition, each episode must keep at least one of the following criteria: tonsillar swelling or exudate, temperature >38ºC, tender anterior cervical adenopathy and positive throat culture for Streptococcal pyogenes.
- •A positive rapid antigen test or throat culture for Streptococcal pyogenes in the 28 days prior to initial care.
- •Patients with a personal history of suppurative and non-suppurative complications after acute streptococcal pharyngitis.
- •Patients with a personal history of invasive disease (bacteraemia, meningitis) due to Streptococcus pyogenes.
- •Immunosuppressed patient.
- •Impossibility of tracking.
- •Patients allergic to amoxicillin.
- •Parents, legal guardians or patients who cannot understand or comply with all the instructions and requirements of the study.
- •If in the opinion of the investigator there are findings in the physical examination, abnormalities in the results of clinical tests or other medical, social or psychosocial factors whose participation could put the patient´s health at risk.
研究者
相似试验
进行中（未招募）
1 期
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome - SICCANOVEKeratoconjunctivitis sicca (KCS), or dry eye syndromeMedDRA version: 9.1 Level: PT Classification code 10023350 Term: Keratoconjunctivitis siccaEUCTR2007-000029-23-GBovagali Pharma S.A.482
进行中（未招募）
1 期
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome - SICCANOVEKeratoconjunctivitis sicca (KCS), or dry eye syndromeMedDRA version: 9.1Level: PTClassification code 10023350Term: Keratoconjunctivitis siccaEUCTR2007-000029-23-FRovagali Pharma S.A.482
进行中（未招募）
不适用
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial ofNOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehiclein Patients with Moderate to Severe Dry Eye Syndrome - SICCANOVEKeratoconjunctivitis siccaEUCTR2007-000029-23-ITOVAGALI PHARMA S.A.482
进行中（未招募）
不适用
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome - SICCANOVEEUCTR2007-000029-23-DEovagali Pharma S.A.482
进行中（未招募）
不适用
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome - SICCANOVEKeratoconjunctivitis sicca (KCS), or dry eye syndromeMedDRA version: 9.1Level: PTClassification code 10023350Term: Keratoconjunctivitis siccaEUCTR2007-000029-23-CZovagali Pharma S.A.482