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

NCT ID: NCT06847126

Last Updated: 2025-04-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2026-06-30

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 drainage/ aspiration of the abscess. The standard care for liver abscess includes empirical antimicrobials consisting both antibacterial and amoebicidal agents along with percutaneous drainage or aspiration of the collection. The antimicrobial regimen should cover against E. histolytica until microbial etiology is established or liver abscess of amoebic etiology is ruled out. But still there is no straightforward general agreement or evidence based on clinical studies regarding the standard protocol for empirical antimicrobials concerning choice, route of administration or duration of antimicrobials therapy. Most of the experts preferred intravenous antimicrobials over oral antimicrobials for the treatment of liver abscess with or without complication. But, there is no clinical trial evidence to support the rational of using intravenous antibiotics up front instead of oral antimicrobials. Recently published institutional study also suggested that empirical oral antimicrobials (Cefexime/Ciprofloxacin) were efficacious for the treatment of uncomplicated liver abscess, successfully managing around 90 % cases of liver abscess. When treating a liver abscess, the choice of antimicrobials and the administration technique must be specially tailored depending upon the existence of complications and the patient's clinical reaction. In the absence of clinical trials, the rational for using of intravenous broad spectrum antibiotics upfront instead of oral antimicrobials for the treatment of liver abscess with or without complications is doubtful and may appear injudicious contributing future rise of antimicrobial resistance. The use of intravenous antibiotics upfront may also unnecessarily lengthen hospital stays, enhance therapeutic expenditure, and raise the risk of hospital-acquired infections in patients who are capable for taking antimicrobials orally. Oral antimicrobials strategy will promote earlier discharge from the hospital and the patient can return to usual activities earlier. This study aims to provide valuable insights into the comparison and efficacy of empirical intravenous Beta-lactam antimicrobials plus Metronidazole and oral Cefixime plus Metronidazole therapy for the treatment of uncomplicated liver abscess. In this randomised controlled open label clinical trial all the patients with newly diagnosed liver abscess confirmed with radiology imaging, either by USG or CT scan, presenting at emergency or medical OPD will be screened for enrolment in the study. Following written informed consent from the participants and/or their legal guardian, those who meet the inclusion and exclusion criteria will be recruited in the study. Subsequently the participants will be randomized into either intravenous or oral antimicrobial group. The intravenous-group will receive Beta-lactam antimicrobials (i.e Piperacillin-Tazobactum 4.5g q 8 hourly or Ceftriaxone 1g q 12 hourly or Meropenem 1g q 8 hourly or Imipenem-Cilastatin 500mg q 6 hourly) Plus intravenous Metronidazole 750mg q 8 hourly for 2weeks. The oral-group will receive tablet Cefixime 200 mg q 12 hourly plus tablet Metronidazole 800 mg q 8 hourly for 2 weeks. Both the group will be provided standard care of therapy including percutaneous drainage or aspiration as per indication and will be followed up for 8 weeks. The primary outcome of clinical cure and secondary outcome of incidence of treatment failure, mortality, duration of antimicrobial therapy, recurrence, adverse drug reaction (ADR), complications will be compared between the groups.

Conditions

Liver Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous Beta-Lactam antimicrobials

Intravenous beta-lactam antimicrobial for 2 weeks Plus Intravenous Metronidazole (750 mg q 8 hourly) for 2 weeks and standard care

Group Type: ACTIVE_COMPARATOR

Intravenous beta-lactam antimicrobial for 2 weeks Plus Intravenous Metronidazole (750 mg q 8 hourly) for 2 weeks

Intervention Type: DRUG

Intravenous beta-lactam antimicrobial for 2 weeks Plus Intravenous Metronidazole (750 mg q 8 hourly) for 2 weeks and standard care

Standard medical care

Intervention Type: OTHER

Percutaneous drainage or aspiration of the abscess along resuscitative and symptomatic medications

Oral Cefixime

Tablet Cefixime (200 mg q 12 hourly) for 2 weeks Plus Table Metronidazole (800 mg q 8 hourly) for 2 weeks and standard care

Group Type: ACTIVE_COMPARATOR

Tablet Cefixime (200 mg q 12 hourly) for 2 weeks Plus Tablet Metronidazole (800 mg q 8 hourly) for 2 weeks

Intervention Type: DRUG

Tablet Cefixime (200 mg q 12 hourly) for 2 weeks Plus Tablet Metronidazole (800 mg q 8 hourly) for 2 weeks

Standard medical care

Intervention Type: OTHER

Percutaneous drainage or aspiration of the abscess along resuscitative and symptomatic medications

Interventions

Intravenous beta-lactam antimicrobial for 2 weeks Plus Intravenous Metronidazole (750 mg q 8 hourly) for 2 weeks

Intravenous beta-lactam antimicrobial for 2 weeks Plus Intravenous Metronidazole (750 mg q 8 hourly) for 2 weeks and standard care

Intervention Type: DRUG

Tablet Cefixime (200 mg q 12 hourly) for 2 weeks Plus Tablet Metronidazole (800 mg q 8 hourly) for 2 weeks

Tablet Cefixime (200 mg q 12 hourly) for 2 weeks Plus Tablet Metronidazole (800 mg q 8 hourly) for 2 weeks

Intervention Type: DRUG

Standard medical care

Percutaneous drainage or aspiration of the abscess along resuscitative and symptomatic medications

Intervention Type: OTHER

Other Intervention Names

Standard care; Standard Medical care

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Deba Prasad Dhibar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Post Graduate Institute of Medical Education and Research (PGIMER)

Chandigarh, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Deba Prasad Dhibar, MD Medicine

Role: CONTACT

drdeba_prasad@yahoo.co.in

+911722756670

Facility Contacts

Deba Prasad Dhibar, MD Medicine

Role: primary

drdeba_prasad@yahoo.co.in, circularinternalmed@gmail.com

+911722756670

Other Identifiers

IEC-INT/2025/Study-2667

Identifier Type: -

Identifier Source: org_study_id