Treatment of Clonorchiasis in Guangxi With Albendazole, Tribendimidine, and Praziquantel

Официальное название

Albendazole, Tribendimidine, and Praziquantel for Clonorchiasis in Guangxi: A Randomized Controlled Trial Comparing Efficacy and Safety

Обзор

The goal of this clinical trial is to evaluate and compare the efficacy and safety of three commonly used antiparasitic drugs-albendazole, tribendimidine, and praziquantel-for the treatment of clonorchiasis, a liver fluke infection acquired by consuming raw or undercooked freshwater fish. This study aims to answer the following primary questions: How effective is each drug in achieving parasitological cure, as measured by clearance of Clonorchis sinensis eggs in stool? What types and frequencies of adverse events are associated with each treatment? Participants in this randomized, open-label trial will: Be randomly assigned to receive one of the three study drugs according to a predefined dosing regimen. Provide stool samples before treatment and at follow-up to assess for Clonorchis sinensis eggs. Undergo a second round of the same treatment regimen and repeated stool examination if eggs are still detected after the first course. Attend follow-up visits, which include symptom assessment, blood tests (hematology and liver function), and abdominal ultrasonography focusing on hepatobiliary changes. Report any side effects, discomfort, or adverse reactions experienced during or after treatment. The findings from this study will help inform optimal therapeutic strategies for clonorchiasis in outpatient clinical settings.

Вмешательства

• Препарат Albendazole
  Participants receive albendazole tablets orally at a total daily dose of 10 mg/kg for 7 consecutive days. The daily dose will be administered in two divided doses. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet as per the physician's recommendation.
• Препарат Tribendimidine
  Patients receive tribendimidine enteric-coated tablets orally at 0.4 g once daily (QD) for 3 consecutive days.
• Препарат praziquantel
  Participants receive praziquantel tablets orally at 25 mg/kg per dose, three times daily (TID) for 2 consecutive days. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet as per the physician's recommendation.

Первичные конечные точки

• Egg Clearance Rate [Срок оценки: From Day 30 to Day 60 after the last dose of treatment]

Вторичные конечные точки (5)

• Symptom Improvement Rate [Срок оценки: Baseline and Day 31 (±1 day) after the last dose of treatment]
• Hepatobiliary Ultrasonographic Improvement [Срок оценки: Baseline and Day 31 (±1 day) after the last dose of treatment]
• Adverse Events (AEs) [Срок оценки: From first dose to Day 30 (±1day) after the last dose of treatment]
• Proportion of Abnormal Hematology and Liver Function Results [Срок оценки: Baseline and Day 31(±1 day) after the last dose of treatment]
• Drug Intolerance Rate [Срок оценки: From first dose to Day 31 (+1 day) after the last dose of treatment]

Критерии участия

Критерии включения

• Adults aged ≥18 years.
• Confirmed diagnosis of Clonorchis sinensis infection based on the latest Expert Consensus on Diagnosis and Treatment of Food-Borne Parasitic Diseases (2023): detection of eggs or adult worms in stool or bile drainage fluid.
• Willing and able to provide written informed consent and comply with study procedures.

Критерии исключения

• Known hypersensitivity or allergy to albendazole, praziquantel, or tribendimidine.
• Electrocardiogram (ECG)-confirmed supraventricular tachycardia or atrial fibrillation.
• Clinically or radiologically diagnosed neurocysticercosis (brain or spinal cord) or ocular cysticercosis (eye or orbit).
• Presence of gallbladder stones or biliary tract obstruction as confirmed by abdominal ultrasound.
• Individuals with severe hepatic, renal, or cardiac dysfunction, or with active peptic ulcer disease.
• Pregnant or breastfeeding individuals, or those of reproductive potential (male or female) who are unwilling to use effective contraception during the study period and for 3 months following the last dose of study medication.
• Anticipated loss to follow-up due to relocation, withdrawal of consent, or other factors affecting adherence to the study protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• People's Hospital of Guangxi Zhuang Autonomous Region — Nanning
• The First Affiliated Hospital of Guangxi Medical University — Nanning

Идентификаторы

NCT: NCT07074444 · 2025-K0110

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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