Comparison of antibiotic treatment of children with uncomplicated liver abscess: with or without metronidazole

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 - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/095307

Enrollment

110

Registered

2025-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K750- Abscess of liver

Interventions

Intervention1: Amoxyclavulanate,Amikacin: Amoxyclavulanate 100mg per kg per day IV TDS, Amikacin 15mg per kg IV OD for 10 to 14 days Control Intervention1: Amoxyclavulanate, Amikacin, Metronidazole: A

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 liverTimepoint: 4 weeks	—

Secondary

Measure	Time frame
Mean time to resolution of fever from initiation of antibioticsTimepoint: 4 weeks;Mean time for resolution of abdominal pain from initiation of antibioticsTimepoint: 4 weeks;Proportion of patients with development of complications due to liver abscessTimepoint: 4 weeks;Duration of hospital stay in daysTimepoint: 4 weeks;Proportion of patients with treatment failureTimepoint: 4 weeks;Proportion of patients with normalization of inflammatory markers by day 7Timepoint: 7 days	—

Measure

Time frame

Mean time to resolution of fever from initiation of antibioticsTimepoint: 4 weeks;Mean time for resolution of abdominal pain from initiation of antibioticsTimepoint: 4 weeks;Proportion of patients with development of complications due to liver abscessTimepoint: 4 weeks;Duration of hospital stay in daysTimepoint: 4 weeks;Proportion of patients with treatment failureTimepoint: 4 weeks;Proportion of patients with normalization of inflammatory markers by day 7Timepoint: 7 days

—

Countries

India

Contacts

Public ContactDr Sulagna Das

Lady Hardinge Medical College

pkpaed@gmail.com9868579672

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026