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Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess (DFALA RCT)

5 september 2026 uppdaterad av: Deba Prasad Dhibar, Post Graduate Institute of Medical Education and Research, Chandigarh

Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess: A Randomized Controlled Clinical Trial

Liver abscess is a common cause of presentation to medical emergency. Among the various causes of liver abscess, Amoebic liver abscess (ALA) is a frequent cause that can resemble pyogenic infections in tropical regions. Prompt diagnosis and empirical antimicrobials along with drainage or aspiration produces successful clinical recovery.

Metronidazole has been the cornerstone of ALA therapy and achieves clinical cure in approximately 90% of uncomplicated cases. It is active against both luminal and tissue forms of Entamoeba histolytica, however it has relatively limited effect against the intestinal (luminal) form of parasite, so intestine may remain colonized after apparent resolution. This persistent intestinal carriage can lead to relapse or ongoing transmission. This prompts physicians to consider Diloxanide furoate as additional luminal agent for treatment of ALA along with metronidazole therapy.

Diloxanide furoate is traditionally administered after metronidazole to eradicate residual intestinal infection and lower relapse rates. However, many patients receive only metronidazole because of cost, limited awareness about luminal therapy, poor adherence, or absence of local comparative evidence. Studies have shown that 30-40% of patients can have inadequate luminal parasite clearance following standard metronidazole therapy for ALA. Frequent relapses have been seen in ALA after treatment with metronidazole. As per literature, Diloxanide furoate eradicates intraluminal cysts in approximately 85-95% of patients with non-invasive amoebiasis.

It remains unclear whether giving Diloxanide furoate at the same time as Metronidazole has any additional benefit compared with Metronidazole alone for patients with ALA. Theoretically, addition of diloxanide furoate could increase overall cure rate, rapid parasite clearance and reduce recurrence.

However, there is no randomized controlled trial available at present to address the research question whether dual therapy with Diloxanide furoate with Metronidazole has any added benefits in ALA. So, this randomized controlled trial has been planned to evaluate whether adding Diloxanide furoate to Metronidazole treatment improves outcomes. This study will generate robust data to formulate/modify the existing guidelines of management of ALA especially in endemic areas.

Research question:

Whether addition of Diloxanide furoate with Metronidazole is more efficacious than Metronidazole monotherapy for treatment of amoebic liver abscess in terms of achieving better clinical cure, parasitic clearance and reduced recurrence.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

STUDY DESIGN: Prospective, randomised controlled, double blinded, clinical trial Population(P): Patients with newly diagnosed amoebic liver abscess presenting to Post graduate Institute of Medical Education and Research, Chandigarh Intervention(I): Diloxanide furoate plus Metronidazole therapy Comparison(C): Metronidazole monotherapy plus placebo Outcome(O): Clinical cure rate, parasite clearance and recurrence rate at 8 weeks follow up Time(T): September 2026 to July 2027

Studietyp

Interventionell

Inskrivning (Beräknad)

220

Fas

  • Fas 3

Kontakter och platser

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Studiekontakt

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Studieorter

  • Indien
    • Chandigarh
      • Chandigarh, Chandigarh, Indien, 160012
        • Post Graduate Institute of Medical Education and Research, Chandigarh, India
        • Kontakt:

Deltagandekriterier

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Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Age >18 years
  • Male or Female
  • Patients with newly diagnosed amoebic liver abscess

Exclusion Criteria:

  • Patients not able to take orally
  • Patients receiving antimicrobials for more than 72 hours before the enrolment in the study
  • History of hypersensitivity reactions to Metronidazole or Diloxanide furoate
  • Pregnancy
  • Patients on antiplatelets/anticoagulation within 4 weeks of presentation
  • Presentation with shock (SBP<90 and/ or DBP< 60 mmHg)
  • Patients with ARDS (SpO2 ≤92%, PaO2/Fio2<300, requiring oxygen therapy)
  • Patients with renal dysfunction / CKD (Creatinine >1.5mg/dl)
  • Patients with altered sensorium (GCS <15)
  • Patients with known malignancy
  • Patients with HIV
  • Not willing for informed consent

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Diloxanide furoate group
Diloxanide furoate group will receive oral Diloxanide furoate 500mg 1 tab TDS for 10 days plus standard care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.
Läkemedel: Diloxanide furoate
Diloxanide furoate group will receive oral Diloxanide furoate 500mg 1 tab TDS for 10 days
Andra namn:
  • Standard care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.
Placebo-jämförare: Placebo group
Will receive matched placebo 1 tab TDS for 10 days plus stand care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.
Övrig: Placebo
matched placebo 1 tab TDS for 10 days
Andra namn:
  • Standard care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Clinical cure
Tidsram: 8 weeks
"Clinical cure" is defined as number of participants becoming asymptomatic with fever resolution for ≥48 hours, including USG demonstrating no drainable collection in the liver along with removal of the pigtail catheter if any.
8 weeks
Treatment failure
Tidsram: 8 weeks

"Treatment failure" is defined as the number of participants fulfilling of any one or more of the following conditions:

  1. Persistently symptomatic even after 72 h of antimicrobial therapy and percutaneous aspiration or drainage of the hepatic collection
  2. Emergence of new collection in the liver during the course of antimicrobial therapy
  3. Emergence of shock and or new onset organ failure (Encephalopathy, ARDS, AKI, MODS) during the course of therapy

e. Patients requiring persistent drainage or repeated aspiration of the abscess even after 4 weeks of antimicrobial therapy
8 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of the therapy
Tidsram: 8 weeks
Number of days of antimicrobial therapy required to achieve clinical cure
8 weeks
Adverse drug reaction (ADR)
Tidsram: 8 weeks
Incidence of adverse drug reaction related to the ongoing antimicrobial therapy.
8 weeks
1. Parasitic clearance
Tidsram: 8 weeks
Number of participant's Stool EH DNA PCR becomes negative after initial positive test at 2 & 8 weeks.
8 weeks
Recurrence of liver abscess
Tidsram: 8 weeks
Number of participants with occurrence of new liver abscess after achieving clinical cure during 8 weeks of follow up.
8 weeks

Samarbetspartners och utredare

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Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

4 september 2026

Primärt slutförande (Beräknad)

31 juli 2027

Avslutad studie (Beräknad)

31 juli 2027

Studieregistreringsdatum

Först inskickad

2 september 2026

Först inskickad som uppfyllde QC-kriterierna

2 september 2026

Första postat (Faktisk)

8 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IEC-INT/2026/DM-4109

Plan för individuella deltagardata (IPD)

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NEJ

IPD-planbeskrivning

All data requests should be submitted to the principal investigator (DPD) for consideration.

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