Comparing intravenous and oral antibiotics for treating liver abscess
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
This study is testing whether intravenous antibiotics or oral antibiotics work better for treating liver abscesses in adults.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT06847126 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of intravenous beta-lactam antibiotics combined with metronidazole against oral cefixime combined with metronidazole in treating liver abscesses. Patients aged 18 and older with symptomatic liver abscess confirmed by imaging will be enrolled. The study will evaluate the outcomes of both treatment regimens over a two-week period, focusing on the resolution of symptoms and any complications. The trial seeks to establish a more effective empirical antimicrobial protocol for liver abscess management.
Who should consider this trial
Good fit: Ideal candidates are symptomatic adults aged 18 and older with a radiologically confirmed liver abscess.
Not a fit: Patients with a history of liver abscess, chronic kidney disease, or those unable to take medications orally may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for liver abscess, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While there is a preference for intravenous antimicrobials in clinical practice, this specific comparison has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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. \- 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. \-
Where this trial is running
Chandigarh
- Post Graduate Institute of Medical Education and Research (PGIMER) — Chandigarh, India (Recruiting)
Study contacts
- Study coordinator: Deba Prasad Dhibar, MD Medicine
- Email: drdeba_prasad@yahoo.co.in
- Phone: +911722756670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.