CTRI/2025/02/081358尚未招募4 期
A Phase 4 Multicentric Open Label Clinical Study to Evaluate the Clinical Safety and Efficacy ofAmoxicillin and Clavulanic Acid in Children with Acute Respiratory Tract Infections
Alkem Laboratories Limited4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年3月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- (SAEs) [From start of treatment (Day 1) to follow-up visit at Day 28] (AEs and
研究概览
简要总结
The study is a prospective, interventional, open-label, non-comparative, multicentric study using a comparative enrolment of participants from 4 sites throughout India. The test drug is amoxicillin and Potassium Clavulanate 600/42.9 mg (14:1) per 5 ml powder for reconstitution into Oral Suspension which will be administered orally once every 12 hours depending on the dose prescribed. There are three visits in the study (Visit 1,Visit 2 and Visit 3). Visit1 (Day 1) is screening visit where subject will be screened as per study inclusion and exclusion criteria’s. Eligible subject will be enrolled into the study and IP will will be dispensed on same day. IP will prescribed as per prescribing instruction mentioned in study protocol and a dairy card will dispensed to the subject to record their symptoms on daily basis. Subject will revisit the site on V2 (Day 14) and symptoms will be checked, IP compliance will be verified and diary card will be reviewed by Investigator. CBC will be performed at V1 and V2 for safety purpose. Subject will revisit the site on V3 (Day 28) for End of study visit. PI will check the recurrence of symptoms status during this visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 6.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, aged between greater than equal to 6 months and less than 18 years.
- •Clinical diagnosis of Acute Respiratory Tract Infections [Upper Respiratory Tract Infections (AOM, tonsillopharyngitis, or sinusitis) or Lower Respiratory Tract Infections (lobar and bronchopneumonia)] i) Diagnosis of AOM confirmed if any of the following is present a)Purulent otorrhea for less than than 24 hours b)Middle ear effusion (MEE) diagnosed based on the presence of at least two of the following otoscopic findings A) decreased/absent tympanic mobility, B) yellow/white discoloration of the tympanic membrane, C) opacification of the tympanic membrane, D) acute inflammation at least any one: ear pain within 24 hours with tugging/rubbing of ear, marked redness of the tympanic membrane, distinct fullness/bulging of the tympanic membrane ii) Diagnosis of tonsillopharyngitis confirmed based on a) Sore throat associated with erythema and/or pharyngeal/tonsillar exudate with or without scarlatiniform rash b) Presence or absence of fever and/or general malaise iii) Diagnosis of sinusitis confirmed based on the following a) Inflammation of nasal mucosa, b) Purulent/mucopurulent nasal or postnasal discharge c) Total score of the following symptoms ≥4 (suggestive of moderate or severe ABRS) A) rhinorrhea (none 0, mild/small amount 1, moderate or severe 2); B) bad mood/productive cough (none 0, mild/small amount 1, moderate or severe: 2); C) nasal/postnasal discharge [none 0 (serous), mild/small amount 1 (mucopurulent, small amount), moderate or severe: 2 (moderate or larger amount)] iv) Diagnosis of lobar and bronchopneumonia confirmed if microbiology-based confirmatory tests are available and if at least three of the following criteria are present a) History of fever (oral temperature greater than 38°C or axillary temperature greater than 37.5°C) or hypothermia (oral temperature less than 35°C or axillary temperature less than 34.5°C) b) Acute onset or worsening of at least two of the following within past 3 days of enrolment A) cough, B) respiratory distress C) tachycardia (greater than 6 months to less than 24 months: greater than 160 beats/min; greater than 24 months to less than 10 years greater than 140 beats/min; greater than 10 years greater than 100 beats/min) (if available in clinical and medical records) D) tachypnea (greater than 6 months to less than 12 months: greater than 50 breaths/min; greater than 12 months to less than 5 years greater than 40 breaths/min; greater than 5 years greater than 20 breaths/min) (if available in clinical and medical records) c) Presence of infiltrates including new alveolar or lobal infiltrate or consolidation as visible on imaging (if available in clinical and medical records)
- •Not requiring hospitalization based on the investigators opinion.
- •Ineffective antimicrobial response within 72 hours of initial treatment (except for AOM).
- •Participants LAR willing to provide informed consent for study participation.
排除标准
- •History of or pre-existing renal insufficiency, hepatic dysfunction, or immunodeficiency
- •Congenital disorders such as maxillofacial dysplasia or Down’s syndrome
- •Spontaneous perforation of the tympanic membrane and drainage for longer than 24 hours
- •Tympanoplastic tube(s) in place, or has anatomic abnormalities associated with recurrent AOM, prolonged MEE, including cleft palate or repair, high-arched palate
- •ABRS patient with surgical history (patient with a pervious surgery is greater than equal to 365 days before and apparently preserved maxillary sinus mucosa or patient with a previous surgery of nasal polypectomy is greater than equal to 90 days before may be considered)
- •Severe cases of CABP including hypoxemic, septic, ventilator-associated or hospital acquired pneumonia
- •Evidence of infectious mononucleosis, leukopenia and/or thrombocytopenia, or diarrhoea at the time of screening
- •Receiving or has received more than one dose of systemic antibiotic or medication affecting bowel movement at the time of enrolment
- •Any condition or concomitant medication, that in the opinion of the investigator, might affect study outcome
- •Any condition in the patient, that in the opinion of the investigator, might worsen upon participation in the study
- •Known allergy or hypersensitivity to the components of the study medication
- •Participation in another clinical trial within past 30 days.
结局指标
主要结局
(SAEs) [From start of treatment (Day 1) to follow-up visit at Day 28] (AEs and
时间窗: Day 1, Day 28
SAEs will be collected).
时间窗: Day 1, Day 28
Number of participants with adverse events (AE) and serious adverse events
时间窗: Day 1, Day 28
次要结局
- Incidence of protocol defined diarrhoea (PDD) (due to study medication) [From start of treatment (Day 1) to end of therapy visit at Day 12-14] The protocol defines diarrhoea as having three or more watery stools in a single day, four or more loose/watery stools in a single day, two watery stools in a row, or three loose/watery stools in a row.(Day 1, Day 14)
- Proportion of patients with primary clinical response. [From start of treatment (Day 1) to end of therapy visit at Day 12-14] At the end of therapy (EOT) visit (Days 12 to 14),the primary clinical response will be evaluated in terms of the study interventions effectiveness or failure. A clinical cure or improvement will be considered a treatment success at EOT. A participant whose clinical outcome is clinical failure (owing to worsening or non-improvement in symptoms) or unable to determine is considered to have failed the treatment.
- Proportion of patients with secondary clinical response [From end of treatment visit (Day 12-14) to follow up visit at Day 22-28]. At follow-up (Days 22 to 28), secondary clinical response will be evaluated in terms of the success or failure of the study intervention. Treatment failure will be clinical recurrence or inability to determine, while treatment success will be lasting clinical cure.
- Time to clinical response evaluated using disease specific subject diary card.(Day 1, Day 14, Day 28)
研究者
研究点 (4)
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