Liver AbscessPhase 3DFALA RCTNCT07807150
Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess
A Phase 3 study testing Diloxanide furoate in people with Liver Abscess and Amoebic Liver Abscess, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Abscess, Amoebic Liver Abscess
- What is being tested?
- Diloxanide furoate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteIndia
- Study dates
- 4 Sep 2026to 31 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Male or Female
- Patients with newly diagnosed amoebic liver abscess
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Post Graduate Institute of Medical Education and Research, Chandigarh, India
Chandigarh, Chandigarh, 160012
Deba Prasad Dhibar, MD, +911722756670, drdeba_prasad@yahoo.co.in
About this study
Official title: 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.
Read more
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.
Read the detailed description
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
- Conditions
- Liver Abscess, Amoebic Liver Abscess
- Being tested
- Diloxanide furoate, Placebo
- Keywords
- Liver abscess, Amoebic liver abscess, Diloxanide furoate
- Medical subject headings
- Liver Abscess, Liver Abscess, Amebic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diloxanide furoateDrug
Also called Standard care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.
Diloxanide furoate group will receive oral Diloxanide furoate 500mg 1 tab TDS for 10 days
PlaceboOther
Also called Standard care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.
matched placebo 1 tab TDS for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Diloxanide furoate group | Experimental | 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. Receives: Drug: Diloxanide furoate |
| Placebo group | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure
"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.
Measured: 8 weeks
Treatment failure
"Treatment failure" is defined as the number of participants fulfilling of any one or more of the following conditions:
- Persistently symptomatic even after 72 h of antimicrobial therapy and percutaneous aspiration or drainage of the hepatic collection
- Emergence of new collection in the liver during the course of antimicrobial therapy
- Emergence of shock and or new onset organ failure (Encephalopathy, ARDS, AKI, MODS) during the course of therapy
- Patients requiring persistent drainage or repeated aspiration of the abscess even after 4 weeks of antimicrobial therapy
Measured: 8 weeks
Secondary outcomes (4)
1. Parasitic clearance
Number of participant's Stool EH DNA PCR becomes negative after initial positive test at 2 \& 8 weeks.
Measured: 8 weeks
Recurrence of liver abscess
Number of participants with occurrence of new liver abscess after achieving clinical cure during 8 weeks of follow up.
Measured: 8 weeks
Duration of the therapy
Number of days of antimicrobial therapy required to achieve clinical cure
Measured: 8 weeks
Adverse drug reaction (ADR)
Incidence of adverse drug reaction related to the ongoing antimicrobial therapy.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start4 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deba Prasad Dhibar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807150
- Sponsor's protocol ID
- IEC-INT/2026/DM-4109
- Acronym
- DFALA RCT
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data requests should be submitted to the principal investigator (DPD) for consideration.
Publications
Chavez-Tapia NC, Hernandez-Calleros J, Tellez-Avila FI, Torre A, Uribe M. Image-guided percutaneous procedure plus metronidazole versus metronidazole alone for uncomplicated amoebic liver abscess. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD004886. doi: 10.1002/14651858.CD004886.pub2.
PubMed 19160244Sharma N, Sharma A, Varma S, Lal A, Singh V. Amoebic liver abscess in the medical emergency of a North Indian hospital. BMC Res Notes. 2010 Jan 25;3:21. doi: 10.1186/1756-0500-3-21.
PubMed 20181006Blessmann J, Binh HD, Hung DM, Tannich E, Burchard G. Treatment of amoebic liver abscess with metronidazole alone or in combination with ultrasound-guided needle aspiration: a comparative, prospective and randomized study. Trop Med Int Health. 2003 Nov;8(11):1030-4. doi: 10.1046/j.1360-2276.2003.01130.x.
PubMed 14629771Kumar R, Patel R, Priyadarshi RN, Narayan R, Maji T, Anand U, Soni JR. Amebic liver abscess: An update. World J Hepatol. 2024 Mar 27;16(3):316-330. doi: 10.4254/wjh.v16.i3.316.
PubMed 38577528Stanley SL Jr. Amoebiasis. Lancet. 2003 Mar 22;361(9362):1025-34. doi: 10.1016/S0140-6736(03)12830-9.
PubMed 12660071
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07807150
- Acronym / sponsor ID
- DFALA RCT / IEC-INT/2026/DM-4109
- Conditions
- Liver Abscess, Amoebic Liver Abscess
- Keywords
- Liver abscess, Amoebic liver abscess, Diloxanide furoate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 4 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Diloxanide furoate group | Experimental | Drug: Diloxanide furoateDiloxanide 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. |
| Placebo group | Placebo comparator | Other: PlaceboWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Male or Female
- Patients with newly diagnosed amoebic liver abscess
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diloxanide furoateAlso: Standard care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.Diloxanide furoate group will receive oral Diloxanide furoate 500mg 1 tab TDS for 10 days | Drug | Diloxanide furoate group |
| PlaceboAlso: Standard care of Metronidazole i.e. intravenous 750mg TDS or oral 800mg 1 tab TDS for 14 days.matched placebo 1 tab TDS for 10 days | Other | Placebo group |
Primary outcome
Clinical cure
Time frame: 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.
Treatment failure
Time frame: 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
4 secondary outcomes
1. Parasitic clearance
Time frame: 8 weeks
Recurrence of liver abscess
Time frame: 8 weeks
Duration of the therapy
Time frame: 8 weeks
Adverse drug reaction (ADR)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 19160244Chavez-Tapia NC, Hernandez-Calleros J, Tellez-Avila FI, Torre A, Uribe M. Image-guided percutaneous procedure plus metronidazole versus metronidazole alone for uncomplicated amoebic liver abscess. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD004886. doi: 10.1002/14651858.CD004886.pub2.
- Background: PubMed 20181006Sharma N, Sharma A, Varma S, Lal A, Singh V. Amoebic liver abscess in the medical emergency of a North Indian hospital. BMC Res Notes. 2010 Jan 25;3:21. doi: 10.1186/1756-0500-3-21.
- Background: PubMed 14629771Blessmann J, Binh HD, Hung DM, Tannich E, Burchard G. Treatment of amoebic liver abscess with metronidazole alone or in combination with ultrasound-guided needle aspiration: a comparative, prospective and randomized study. Trop Med Int Health. 2003 Nov;8(11):1030-4. doi: 10.1046/j.1360-2276.2003.01130.x.
- Background: PubMed 38577528Kumar R, Patel R, Priyadarshi RN, Narayan R, Maji T, Anand U, Soni JR. Amebic liver abscess: An update. World J Hepatol. 2024 Mar 27;16(3):316-330. doi: 10.4254/wjh.v16.i3.316.
- Background: PubMed 12660071Stanley SL Jr. Amoebiasis. Lancet. 2003 Mar 22;361(9362):1025-34. doi: 10.1016/S0140-6736(03)12830-9.
- Individual participant dataSharing planned: No. All data requests should be submitted to the principal investigator (DPD) for consideration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diloxanide furoate in people with Liver Abscess and Amoebic Liver Abscess, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deba Prasad Dhibar, MD (+911722756670, drdeba_prasad@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07807150, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.