| CTRI Number |
CTRI/2025/11/097217 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparation of Ampicillin-Gentamicin and Ceftriaxone- Gentamicin in the Treatment of Diarrhea with Dehydration in Hospitalized Children of Severe Acute Malnutrition (SAM) Between 2 Months- 5 Years by comparing duration of hospital stay between both the groups. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srikanta Basu |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Paediatrics, Lady Hardinge Medical College & Associated Hospitals, Shaheed Bhagat Singh Marg, New Delhi-110001
Central
DELHI
110001
India |
| Phone |
9818291595 |
| Fax |
|
| Email |
srikantabasu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srikanta Basu |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Paediatrics, Lady Hardinge Medical College & Associated Hospitals, Shaheed Bhagat Singh Marg, New Delhi-110001
Central
DELHI
110001
India |
| Phone |
9818291595 |
| Fax |
|
| Email |
srikantabasu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abhishek Anand |
| Designation |
Post Graduate Resident |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Paediatrics, Lady Hardinge Medical College & Associated Hospitals, Shaheed Bhagat Singh Marg, New Delhi-110001
Central
DELHI
110001
India |
| Phone |
8851135070 |
| Fax |
|
| Email |
anand.abhishek218@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.Srikanta Basu |
| Address |
DEpartment of Paediatrics,Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi- 110001 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrAbhishek Anand |
Lady Hardinge Medical College |
Department of Paediatrics,Lady Hardinge Medical College, Shaheed Bhagat Singh Marg,Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi-110001
Central
DELHI |
8851135070
anand.abhishek218@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Lady Hardinge Medical College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ampicillin -Gentamicin |
Inj. Ampicillin 50mg/kg/dose 6 hourly and Inj. Gentamicin 7.5mg/kg once a day for 7-10 days and the standard treatment. |
| Intervention |
Ceftriaxone-Gentamicin |
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. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 2 months to 5 years with SAM and complications admitted in our hospital.
2. 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
|
|
| ExclusionCriteria |
| Details |
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.
3. Children with known chronic liver, kidney, cardiac disorders, HIV,TB, IEM etc
4. Known allergy or contraindication to Ampicillin, Gentamicin, Ceftriaxone.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Duration of hospital stay in days as per discharge criteria defined by:
1.Frequency of stool less than 5 per day
2.Accepting 80% of daily feeds
3.Minimum average weight gain in 3 days more than 5gm/kg/day
4.Resolution of other complications: hypoglycaemia, hypothermia, dyselectrolytemias.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
2.Dose modification
3.Drug discontinuation or substitution
|
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |