Actively Recruiting
Comparison of Empirical Intravenous Beta-Lactam Antimicrobials Plus Metronidazole and Oral Cefixime Plus Metronidazole Therapy for the Treatment of Liver Abscess: an Open Label Randomized Controlled Clinical Trial
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2025-04-13
220
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Liver abscess is a serious medical condition that requires prompt treatment using antimicrobials, with or without drainage of the abscess. This trial investigates the comparison between intravenous Beta-lactam antimicrobials plus Metronidazole and oral Cefixime plus Metronidazole for treating uncomplicated liver abscesses. The study aims to clarify the best antimicrobial approach, as current practices lack clear clinical trial evidence, especially regarding the use of intravenous antibiotics upfront. Participants diagnosed with liver abscess through imaging will be randomly assigned to one of two treatment groups. One group receives intravenous Beta-lactam antimicrobials (such as Piperacillin-Tazobactum, Ceftriaxone, Meropenem, or Imipenem-Cilastatin) plus intravenous Metronidazole for two weeks. The other group receives oral Cefixime plus oral Metronidazole for two weeks. Both groups will receive standard care, including drainage or aspiration when indicated, and will be followed for eight weeks. During the study, participants will be monitored for clinical cure, treatment failure, mortality, therapy duration, recurrence, adverse reactions, complications, hospital stay length, and readmissions over an eight-week period. Researchers will assess these outcomes to compare the effectiveness and safety of the two treatment strategies. The study includes regular evaluations and aims to provide evidence to guide antimicrobial use in liver abscess management.
CONDITIONS
Brief Title
Empirical Intravenous Beta-Lactam Plus Metronidazole Vs Oral Cefixime Plus Metronidazole for the Treatment of Liver Abscess
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic patients with liver abscess confirmed by CT scan or ultrasound
- Age 18 years or older
- Any gender (male or female)
You will not qualify if you...
- Past history of liver abscess
- Chronic kidney disease
- Hypersensitivity to Metronidazole, Cefixime, or Beta-lactam antimicrobials
- Organ dysfunction with shock (blood pressure below 90/60 mmHg)
- Acute respiratory distress syndrome needing oxygen therapy
- Encephalopathy with altered consciousness (GCS less than 15)
- Acute kidney injury with raised serum creatinine
- Inability to take oral medications
- Pregnancy
- Antimicrobial treatment for more than 48 hours before admission
- Use of blood thinners such as antiplatelets or anticoagulants within 4 weeks before study
- Unwillingness to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 2 weeks
Participants receive either intravenous beta-lactam antimicrobials plus metronidazole or oral cefixime plus metronidazole for the treatment of liver abscess along with standard medical care.
Visits during the 2-week treatment period as per hospital protocol
Duration - Up to 6 weeks after treatment
Participants are monitored for clinical cure, treatment failure, adverse drug reactions, and other outcomes after treatment ends.
Follow-up visits up to 8 weeks post treatment
Trial Site Locations
Total: 1 location
1
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, India, 160012
Actively Recruiting
Research Team
D
Deba Prasad Dhibar, MD Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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