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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Egg Clearance Rate — From Day 30 to Day 60 after the last dose of treatment
  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.

Trial sites (2)

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