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

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.