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

Phase 4RecruitingNCT07074444

First Affiliated Hospital of Guangxi Medical University318 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

318

Conditions

Clonorchiasis

AlbendazoleDRUG

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.

TribendimidineDRUG

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

praziquantelDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Egg Clearance Rate

The primary outcome is the proportion of participants who test negative for Clonorchis sinensis eggs in all three stool samples collected at different time points post-treatment.

Time frame: From Day 30 to Day 60 after the last dose of treatment

Secondary Outcomes

Symptom Improvement Rate

Symptom improvement will be assessed using a standardized symptom questionnaire or physician-recorded clinical evaluation. Typical symptoms associated with clonorchiasis-such as right upper abdominal pain, fatigue, and diarrhea-will be documented at baseline and again during the first follow-up visit, which takes place between Day 30 and Day 33 after the last dose of treatment. A symptom is considered improved if it shows significant relief or has completely resolved by that follow-up visit.

Time frame: Baseline and Day 31 (±1 day) after the last dose of treatment

Hepatobiliary Ultrasonographic Improvement

Among participants who show abnormal hepatobiliary findings on baseline abdominal ultrasonography (e.g., bile duct dilation, gallbladder wall thickening, or liver echogenicity changes), a repeat ultrasound will be performed at the follow-up visit (Day 30-33 after the last dose of treatment) to assess for resolution or improvement. Improvement is defined as partial or complete normalization of previously abnormal imaging features, as interpreted by a qualified radiologist.

Time frame: Baseline and Day 31 (±1 day) after the last dose of treatment

Adverse Events (AEs)

Adverse events (AEs) will be collected from the initiation of treatment until the first follow-up visit, which occurs between Day 30 and Day 33 after the last dose of treatment. All events will be graded according to CTCAE version 5.0, and causality will be assessed using a five-level scale (definitely, probably, possibly, possibly not, and definitely not related). Serious adverse events (SAEs) will be documented and reported separately.

Time frame: From first dose to Day 30 (±1day) after the last dose of treatment

Proportion of Abnormal Hematology and Liver Function Results

Venous blood samples will be collected at baseline and follow-up (Day 30-33 after the last dose of treatment) for hematology and liver function tests. An abnormal result is defined as any value exceeding the laboratory reference range or deemed clinically significant by the investigator.

Time frame: Baseline and Day 31(±1 day) after the last dose of treatment

Drug Intolerance Rate

Drug intolerance is defined as the inability to complete the planned treatment regimen due to serious adverse reactions, interruption of medication, or participant refusal. Data will be collected via participant self-report and investigator inquiry at the follow-up visit.

Time frame: From first dose to Day 31 (+1 day) after the last dose of treatment