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

Empirical Intravenous Beta-Lactam Plus Metronidazole Vs Oral Cefixime Plus Metronidazole for the Treatment of Liver Abscess | DecenTrialz