跳至主要内容
临床试验/CTRI/2019/07/020174
CTRI/2019/07/020174尚未招募2/3 期

COMPARISON OF EFFICACY OF ORAL AMOXICILLIN VERSUS PARENTERAL CEPHALOSPORIN IN TREATMENT OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA A PROSPECTIVE SINGLE BLINDED PARALLEL DESIGN,RANDOMIZED CONTROL TRIAL IN A TERTIARY CARE HOSPITAL OF METROPOLITAN CITY.

DR SUSHANT S MANE1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
COMPARISON OF EFFICACY OF ORAL AMOXICILIN VERSUS PARENTERAL CEPHALOSPORIN IN CASE OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA IN CHILDREN IN TERMS OF DAY OF DEFERVENSCENCE OF FEVER, DAY OF SETTLEMENT OF RESPIRATORY DISTRESS, DAY OF SUBSIDENCE OF COUGH, DURATION OF ANTIBIOTIC, DURATION OF HOSPITAL STAY

研究概览

简要总结

THIS STUDY IS PROSPECTIVE, SINGLE BLINDED, PARALLEL DESIGN, RANDOMIZED CONTROL TRIAL  COMPARING THE EFFICACY OF ORAL AMOXICILLIN VERSUS PARENTERAL  CEPHALOSPORIN IN TREATMENT OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA CONDUCTED IN TERTIARY CARE HOSPITAL GRANT GMC AND JJ HOSPTAL, MUMBAI IN PAEDIATRIC WARD OVER THE DURATION OF 18 MONTHS. PRIMARY OUTCOME MEASURES IN TERMS OF DAY DEFERVENSCENCE OF FEVER, DAY OF SETTLEMENT OF RESPIRATORY DISTRESS, DAY OF SUBSIDENCE OF COUGH, DURATION OF ANTIBIOTICS AND DURATION OF HOSPITAL STAY.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
6.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ALL CHILD IN THE AGE GROUP OF 6 MONTHS TO 12 YEARS ADMITTED IN PAEDIATRIC WARD AND CLINICALLY DIAGNOSED AS UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA IRRESPECTIVE OF ETIOLOGY.

排除标准

  • LESS THAN 6 MONTHS OF AGE.
  • CHILD ADMITTED IN PAEDIATRIC INTENSIVE CARE UNIT.
  • CHILD WITH UNDERLYING IMMUNODEFICIENCY INCLUDING ACQUIRED AND CONGENITAL CAUSES.
  • CHILD WITH CO-MORBID CONDITIONS LIKE DENGUE, MEASLES ETC.
  • CHILD WITH UNDERLYING HEREDITARY DISORDER LIKE CYSTIC FIBROSIS, SICKLE CELL DISEASE, DISORDERS OF CILIA ETC.
  • CHILD WITH UNDERLYING ANATOMICAL DISORDER LIKE PULMONARY SEQUESTRATION, LOBAR PNEUMONIA, GASTROESOPHAGEAL REFLUX DISORDER, TRACHEOESOPHAGEAL FISTULA AND BRONCHOPULMONARY DYSPLASIA.

结局指标

主要结局

COMPARISON OF EFFICACY OF ORAL AMOXICILIN VERSUS PARENTERAL CEPHALOSPORIN IN CASE OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA IN CHILDREN IN TERMS OF DAY OF DEFERVENSCENCE OF FEVER, DAY OF SETTLEMENT OF RESPIRATORY DISTRESS, DAY OF SUBSIDENCE OF COUGH, DURATION OF ANTIBIOTIC, DURATION OF HOSPITAL STAY

时间窗: 18 MONTHS

次要结局

  • COMPARISON OF EFFICACY OF ORAL AMOXICILIN VERSUS PARENTERAL CEPHALOSPORIN IN CASE OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA IN CHILDREN IN TERMS OF DAY OF DEFERVENSCENCE OF FEVER, DAY OF SETTLEMENT OF RESPIRATORY DISTRESS, DAY OF SUBSIDENCE OF COUGH, DURATION OF ANTIBIOTIC, DURATION OF HOSPITAL STAY(18 MONTHS)

研究者

发起方
DR SUSHANT S MANE
申办方类型
Other [self]

研究点 (1)

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