Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Clinical cure
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Male or Female
- •Patients with newly diagnosed amoebic liver abscess
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo (Other)
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.
干预措施: Diloxanide furoate (Drug)
结局指标
主要结局
Clinical cure
时间窗: 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
时间窗: 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
次要结局
- Duration of the therapy(8 weeks)
- Adverse drug reaction (ADR)(8 weeks)
- 1. Parasitic clearance(8 weeks)
- Recurrence of liver abscess(8 weeks)
研究者
Deba Prasad Dhibar
Principal Investigator
Post Graduate Institute of Medical Education and Research, Chandigarh