CTRI/2024/01/061255尚未招募Unknown
A Prospective, Observational, Multicentric Study to Evaluate Safety and Efficacy of Faropenem inPediatric Patients with Respiratory Tract Infections (RTIs), Or Urinary Tract Infection (UTI) - NI
Alkem Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Patients of either gender, aged greater than equal to 6 months and <18 years
- •2. Subjects clinically diagnosed with RTIs or UTI A. Diagnosis of CABP / Acute bronchitis confirmed if the following criterias are present: a.History of fever (oral temperature >38°C or axillary temperature >37.5°C) or hypothermia (oral temperature <35°C or axillary temperature <34.5°C). b. Acute onset or worsening of at least two of the following within past (5 days of enrolment): I) tachycardia ( >6 months to <24 months: >160 beats/min; greater than equal to 24 months to <10 years: >140 beats/min; greater than equal to 10 years: >100 beats/min), II) tachypnea ( >6 months to <12 months: >50 breaths/min; greater than equal to 12 months to <5 years: >40 breaths/min; greater than equal to 5 years: >20 breaths/min), III) Cough, dyspnea, grunting, sputum production, chest pain, cyanosis, increased work of breathing, c. At least one of the following hematology findings (if available in clinical and medical records): leukocytosis ( >15,000 WBC/mm3), >15% immature neutrophils (bands), leukopenia. B. Diagnosis of ABRS confirmed based on the following: a. Inflammation nasal mucosa, purulent/mucopurulent nasal or postnasal discharge, or pathological shadow in the paranasal sinus on a radiogram b. Total score of the following symptoms greater than equal to 4 (suggestive of moderate or severe ABRS): I) rhinorrhea (none: 0, mild/small amount: 1, moderate or severe: 2); II) bad mood/productive cough (none: 0, mild/small amount: 1, moderate or severe: 2); III)nasal/postnasal discharge [none: 0 (serous), mild/small amount: 1 (mucopurulent, small amount), moderate or severe: 2 (moderate or larger amount)] C. Diagnosis of UTI confirmed based on urine culture (colony count greater than equal to 105 CFU/ml) or Urine R/M if available.D. Diagnosis of Pharyngitis and Tonsillitis based on clinical diagnosis of mild to moderate upper respiratory tract infection (pharyngitis or tonsillitis or tonsillo-pharyngitis) calculated as per modified Centor score (McIsaac score14) greater than equal to 3 during the screening period. MacIsaac score parameter: a) Body Temperature greater than equal to 37.5 degree C (axillary)- 1, b) Absence of cough- 1, c) Swollen, tender anteriorcervical nodes- 1, d) Tonsillar exudate or swelling- 1,e) Age 3-14 years- 1,Age 15-44 years- 0, 45 years and above -(-1).Cumulative Score#, # Not appropriate to patients who are younger than 3 years old. According to the investigators discretion, patients under the age of 3 will be evaluated. E. Patients and patient’s LAR willing to provide consent and assent (Applicable for age group of 7 to <18) for study participation.
排除标准
- •1. Severe cases of CABP including hypoxemic or septic as per Investigators judgement.
- •2. Evidence of infectious mononucleosis clinically, leukopenia and/or thrombocytopenia, or diarrhoea at the time of screening (If available in clinical and medical records)
- •3. Receiving or has received more than one dose of systemic antibiotic or medication (within 72 hours prior to enrolment) affecting bowel movement.
- •4. Any condition (epilepsy or cardiovascular disease etc) or concomitant medication, that in the opinion of the investigator, might affect study outcome
- •5. Any condition in the patient, that in the opinion of the investigator, might worsen upon participation in the study
- •6. Known allergy or hypersensitivity to the components of the study medication
- •7. Participation in another clinical trial within past 30 days
研究者
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