Clinical Evaluation of Azithromycin in Upper Respiratory Tract Infections in Pediatric Patients: A Multicentric, Prospective, Open Label, Real World Observational study (CURE URTI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 24
- 主要终点
- Clinical effectiveness to azithromycin will be assessed on the basis of mean reduction in total clinical score for assessing regression of signs & symptoms at 7 ± 1 day
研究概览
简要总结
Thismulticentric, prospective, open-label, real-world observational study aims toevaluate the effectiveness and safety of Azithral Liquid 200 (Azithromycin oral suspension 200mg/ 5ml)prescribed for 5 days in pediatric patients aged two to twelve years with acutepharyngitis, tonsillitis, or otitis media. The study will recruit 600 pediatricpatients with URTIs across multiple centers over a period of four months (April2025 – July 2025). Patients meeting the inclusion and exclusion criteria willbe enrolled after obtaining informed consent from parents or legally acceptablerepresentatives. Each enrolled patient will be assigned a unique allotmentnumber for confidentiality. Azithromycin liquid suspension will be prescribedas per local guidelines and the clinician’s judgment. Patients will have afollow-up visit on Day 7 ± 1; if not feasible, follow-up will be conductedtelephonically. Data will be collected using a hard-copy case report form (CRF).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must meet all of the following criteria to be included in this study: 1) Pediatric patients, aged 2-12 years of age(inclusive of both) of either gender with acute onset of pharyngitis/ tonsillitis/ otitis media as indicated by presence of fever, visiting to outpatient department of pediatrics and whose parents/ Legally acceptable representative (LAR) are ready to participate in the study by signing the written informed consent.
- •Pediatric patients suitable for receiving azithromycin based on investigator’s clinical judgement and locally approved prescribing information.
- •For patients with acute pharyngitis/ tonsillitis/ pharyngo-tonsillitis, presence of at least two specific clinical symptoms and signs such as: A)Clinical Symptoms: sore throat; pharyngeal erythema; tonsillar erythema B)Clinical signs: tonsillar enlargement and erythema; tonsillar exudates; painful cervical lymphadenopathy 4) For patients with acute Otitis Media, A) Presence of middle ear effusion indicated by any of the following: a) Bulging of tympanic membrane b) Limited or absent motility of tympanic membrane c) Air-fluid level behind the tympanic membrane B) Signs and Symptoms of middle ear inflammation as indicated by either a) Distinct erythema of tympanic membrane or b) Distinct otalgia or irritability (discomfort clearly referable to the ears that results in interference with or precludes normal activity or sleep).
排除标准
- •Patients who meet any of the following criteria will be excluded from this study: 1) Pediatric Patients with URTIs those who are not suitable to receive Azithromycin (Allergic, Contraindication, receiving antibiotic other than Azithromycin) based on investigator’s judgement.
- •Patients with LRTIs or any other clinical conditions requiring treatment with antibiotics/ antimicrobials.
- •Participation in any clinical study within 4 weeks prior to enrolment 4) Patient suggestive of complicated Acute otitis media with anyone of : a)Signs and symptoms of any complication of AOM b)Otitis externa c)Tympanostomy tubes presence.
- •Patients not suitable to receive Azithromycin Liquid formulation (Weight of patient above 50 kg).
结局指标
主要结局
Clinical effectiveness to azithromycin will be assessed on the basis of mean reduction in total clinical score for assessing regression of signs & symptoms at 7 ± 1 day
时间窗: Clinical effectiveness at Day 1(first visit) and Day 7(Follow up visit)
次要结局
- 1) Number (proportion) of patients showing mean reduction in total clinical score as assessed at 7 ± 1 day evaluated as(A) Cure: Complete disappearance of signs & symptoms present at 7 ± 1 day)