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

First Affiliated Hospital of Guangxi Medical University

Status and phase: Enrolling; Phase 4

Conditions: Clonorchiasis

Treatments: Drug: Albendazole; Drug: praziquantel; Drug: Tribendimidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07074444

2025-K0110

Details and patient eligibility

About

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.

Enrollment: 318 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged ≥18 years.
2. 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.
3. Willing and able to provide written informed consent and comply with study procedures.

Exclusion criteria

1. Known hypersensitivity or allergy to albendazole, praziquantel, or tribendimidine.
2. Electrocardiogram (ECG)-confirmed supraventricular tachycardia or atrial fibrillation.
3. Clinically or radiologically diagnosed neurocysticercosis (brain or spinal cord) or ocular cysticercosis (eye or orbit).
4. Presence of gallbladder stones or biliary tract obstruction as confirmed by abdominal ultrasound.
5. Individuals with severe hepatic, renal, or cardiac dysfunction, or with active peptic ulcer disease.
6. 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.
7. Anticipated loss to follow-up due to relocation, withdrawal of consent, or other factors affecting adherence to the study protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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318 participants in 3 patient groups

Praziquantel

Active Comparator group

Description:

Praziquantel tablets: Administer orally at 25 mg/kg per dose, three times daily (TID) for 2 consecutive days. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the dose will be adjusted to the nearest whole tablet according to the physician's recommendation.

Treatment:

Drug: praziquantel

Albendazole

Experimental group

Description:

Albendazole tablets: Administer orally at 10 mg/kg/day for 7 consecutive days. The daily dose will be administered in two divided doses. The dose will be adjusted based on the participant's body weight. If the calculated dose results in a non-integer number of tablets, the actual dose may be adjusted to the nearest whole tablet. The specific dose will be adjusted according to the physician's recommendation.

Treatment:

Drug: Albendazole

Tribendimidine

Experimental group

Description:

Tribendimidine enteric-coated tablets: Administer orally at 0.4 g once daily (QD) for 3 consecutive days.

Treatment:

Drug: Tribendimidine