Comparative Efficacy Between Ampicillin-Gentamicin and Ceftriaxone- Gentamicin in the Treatment of Diarrhea with Dehydration in Hospitalized Children Between 2 Months- 5 Years with Severe Acute Malnutrition (SAM):A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Duration of hospital stay in days as per discharge criteria defined by:
研究概览
简要总结
The protocol outlines a randomized controlled trial to compare the efficacy between treatment of Diarrhea with Dehydration in Hospitalized Children Between 2 Months- 5 Years with Severe Acute Malnutrition (SAM).The study aims to compare the efficacy of ampicillin-gentamicin over ceftriaxone-gentamicin in the treatment of diarrhea with dehydration in admitted children(2 month to 5 years) with severe acute malnutrition (SAM).The primary objective is to compare the efficacy of ampicillin-gentamicin over ceftriaxone-gentamicin in the treatment of diarrhea with dehydration in admitted children(2 month to 5 years) with severe acute malnutrition (SAM) on the basis of length of hospital stay(in days) between the two treatment groups. Secondary objectives include to compare average weight gain between both the groups ,to study the rate of treatment failure, escalation, change or de-escalation in the course of antibiotics, to identify the diarhogenic bacteria in stool and blood before the initiation of antibiotics and before discharge , to study the proportion of children developing adverse effects of drugs in both the groups.
The study is a hospital based randomised controlled trial study, open label and parallel group with 1:1 allocation ratio.The minimum calculated sample size for each group is 65.
We will use a sample of convenience and enroll minimum 40 in each group.Participants will be randomly allocated in a 1:1 ratio into two groups- Group A (Ampicillin-Gentamicin) and Group B (Ceftriaxone-Gentamicin) using block randomization with equal allocation. Group A will receive Inj. Ampicillin 50mg/kg/dose 6 hourly and Inj. Gentamicin 7.5mg/kg once a day for 7-10 days and the standard treatment and Group B will receive Inj.Ceftriaxone 100 mg/kg/day in 2 divided doses and Inj. Gentamicin 7.5mg/kg once a day for 7-10 days and the standard treatment, both the groups will receive standard SAM management protocols in addition to antibiotics such as therapeutic feeds (starter and catch up feeds), supplements for 2 weeks included: vitamin A, zinc, folic acid, magnesium, potassium, multivitamins (B complex including C, E, B12 ) and vitamin D twice the RDA .If any complications arises such as hypoglycemia, hypothermia or electrolyte imbalance it will be managed according to standard management protocols.If blood culture shows resistance, treatment will be guided by clinical response. Assigned antibiotics will be administered and daily monitoring of stool frequency, feeding acceptance, weight gain and vitals signs and complication will be done.If any escalation, change after clinical assesment or antibiogram or any adverse event related to antibiotics arises it will noted.Outcome assessment will be done at the end of treatment phase ,based on the reduction in duration of hospital stay as per the discharge criteria.Before discharge repeat cultures and blood tests, nutritional counselling for parents and final assessment will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 2 months to 5 years with SAM and complications admitted in our hospital.
- •Children having diarrhea with dehydration without signs of shock 3.Case definition- Diagnostic criteria of SAM in children from 6-59 months of age: Weight for height less than -3SD or Mid arm circumference(MUAC) of less than 115mm or Bilateral pitting edema of both feet Diagnostic criteria of SAM in infants of less than 6months of age and more than 45 cm in length: Weight-for-height less than -3SD or bilateral pitting edema of both feet( nutritional origin) or both.
排除标准
- •1.Patient having diarrhea with dehydration with signs of shock.
- •2.Children were excluded from the study if they had been had received oral or parenteral antibiotics for more than 48 hrs in the previous seven days.
- •Children with known chronic liver, kidney, cardiac disorders, HIV,TB, IEM etc
- •Known allergy or contraindication to Ampicillin, Gentamicin, Ceftriaxone.
结局指标
主要结局
Duration of hospital stay in days as per discharge criteria defined by:
时间窗: 4 weeks
1.Frequency of stool less than 5 per day
时间窗: 4 weeks
2.Accepting 80% of daily feeds
时间窗: 4 weeks
3.Minimum average weight gain in 3 days more than 5gm/kg/day
时间窗: 4 weeks
4.Resolution of other complications: hypoglycaemia, hypothermia, dyselectrolytemias.
时间窗: 4 weeks
次要结局
- Proportion of children achieving average weight gain in 3 days more than 5gm per kg per day: Defined as the mean weight gain per kilogram body weight recorded over three consecutive days during hospitalization.(3 days)
- Proportion of children with requirement for escalation for antibiotic therapy or change during the course of treatment as per unit protocol.
- Proportion of children having identifiable and culture positive diarhogenic bacteria in stool and blood before the initiation of antibiotics and before discharge in both the groups
- Proportion of children developing adverse effects of drugs in both the group is defined as any new clinical symptom or lab abnormality temporally associated with the administered antibiotic(s), requiring:(1.Medical intervention)
研究者
Dr Srikanta Basu
Lady Hardinge Medical College