| CTRI Number |
CTRI/2025/09/095307 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of antibiotic treatment of children with uncomplicated liver abscess: with or without metronidazole |
|
Scientific Title of Study
|
Clinical Outcome of children aged 1-18 years with uncomplicated, suspected pyogenic liver abscess treated with empiric antibiotics with and without metronidazole: 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 Sulagna Das |
| Designation |
Post graduate resident, Paediatrics |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Paediatrics, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9874989145 |
| Fax |
|
| Email |
sulagnadas1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Kumar |
| Designation |
Director Professor and Head of the department, department of Paediatrics |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Paediatrics, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9868579672 |
| Fax |
|
| Email |
pkpaed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sulagna Das |
| Designation |
Post graduate resident, Paediatrics |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Paediatrics, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi 110001
New Delhi
DELHI
110001
India |
| Phone |
9874989145 |
| Fax |
|
| Email |
sulagnadas1998@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Praveen Kumar |
| Address |
Department of Paediatrics, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Lady Hardinge Medical College, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Dr Sulagna Das |
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
New Delhi
DELHI |
9874989145
sulagnadas1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Lady Hardinge Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K750||Abscess of liver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amoxyclavulanate, Amikacin, Metronidazole |
Amoxyclavulanate 100mg per kg per day IV TDS, Amikacin 15mg per kg IV OD, Metronidazole 45mg per kg per day IV in TDS for 10 to 14 days |
| Intervention |
Amoxyclavulanate,Amikacin |
Amoxyclavulanate 100mg per kg per day IV TDS, Amikacin 15mg per kg IV OD for 10 to 14 days |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 to 18 years presenting with suggestive symptoms of uncomplicated, pyogenic liver abscess (high grade fever, abdominal pain, vomiting) and diagnosis of liver abscess confirmed by ultrasonography of abdomen. |
|
| ExclusionCriteria |
| Details |
1)Patients with known underlying chronic disease or immunodeficiency.
2)Patients who have received intravenous antibiotics or dose of Metronidazole from outside for more than 48 hours.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with clinical resolution at 4 weeks defined as asymptomatic (absence of fever and abdominal pain) with no drainable pus persisting in the liver |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean time to resolution of fever from initiation of antibiotics |
4 weeks |
| Mean time for resolution of abdominal pain from initiation of antibiotics |
4 weeks |
| Proportion of patients with development of complications due to liver abscess |
4 weeks |
| Duration of hospital stay in days |
4 weeks |
| Proportion of patients with treatment failure |
4 weeks |
| Proportion of patients with normalization of inflammatory markers by day 7 |
7 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="2"
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
|
This study is a randomized controlled trial designed to evaluate whether the combination of Amoxyclavulanate and Amikacin (intervention) is non-inferior to the standard empiric therapy of Amoxyclavulanate, Amikacin, and Metronidazole (control) in achieving clinical resolution of uncomplicated, suspected pyogenic liver abscess in children aged 1–18 years at 4 weeks. The primary objective is to compare the clinical resolution rate between the two groups, while secondary objectives include comparing time to symptom resolution, duration of hospital stay, development of complications, treatment failure rates, and normalization of inflammatory markers by day 7. The study will be conducted at Lady Hardinge Medical College and Kalawati Saran Children’s Hospital. It will enroll 110 children meeting the inclusion criteria, with randomization done using variable block sizes and allocation concealed through sealed opaque envelopes. Participants will be randomized into two groups: Group 1 will receive IV Amoxyclavulanate and Amikacin, while Group 2 will receive the same regimen with the addition of Metronidazole, for 10–14 days followed by oral antibiotics. USG-guided aspiration and pus culture will be performed as indicated, and treatment modified based on clinical response or culture results. The study is powered at 80% with a non-inferiority margin of 10%, targeting a sample size of 53 children per group, after accounting for a 10% attrition rate total sample size is 110.
|