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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Clonorchiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Praziquantel

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.

Group Type ACTIVE_COMPARATOR

praziquantel

Intervention Type DRUG

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.

Albendazole

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.

Group Type EXPERIMENTAL

Albendazole

Intervention Type DRUG

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.

Tribendimidine

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

Group Type EXPERIMENTAL

Tribendimidine

Intervention Type DRUG

Patients receive tribendimidine enteric-coated tablets orally at 0.4 g once daily (QD) for 3 consecutive days.

Interventions

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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.

Intervention Type DRUG

Tribendimidine

Patients receive tribendimidine enteric-coated tablets orally at 0.4 g once daily (QD) for 3 consecutive days.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No