Status:
RECRUITING
Empirical Intravenous Beta-Lactam Plus Metronidazole Vs Oral Cefixime Plus Metronidazole for the Treatment of Liver Abscess
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Liver Abscess
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Liver abscess (LA) is potentially life threatening medical emergency requiring prompt medical intervention. The backbone of therapy is prompt empirical antimicrobial with or without percutaneous drain...
Eligibility Criteria
Inclusion Criteria: All symptomatic patients with liver abscess verified by radiological imaging, either by computed tomography (CT) scan or ultrasound (USG), regardless of gender (male or female) and age ≥ 18 years, will be screened for registration in the study.
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Exclusion Criteria: Patients with past history of liver abscess, chronic kidney disease (CKD), hypersensitivity to either Metronidazole or Cefixime or Beta-lactam antimicrobials will not be allowed to participate in the study. Patients with organ dysfunction with shock (blood pressure < 90/60 mmHg), acute respiratory distress syndrome requiring oxygen therapy (PaO2/FiO2 ≤ 300 or SpO2 ≤92%), encephalopathy (altered sensorium with GCS < 15), acute kidney injury (increase in serum creatinine to ≥ 1.5 times from the baseline or serum creatinine ≥ 1.5) and not able to take orally will not be considered for participation in the study. Patients who are pregnant, have already received antimicrobials for more than 48 hours before to admission, or are receiving blood thinners such as antiplatelets or anticoagulants within 4 weeks of presentation and are unwilling to provide informed consent will also be excluded from the trial.
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Key Trial Info
Start Date :
February 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06847126
Start Date
February 25 2025
End Date
June 30 2026
Last Update
April 13 2025
Active Locations (1)
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1
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India, 160012