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

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

Primary outcomes

• Egg Clearance Rate [From 4 weeks to 4 months after the last dose of treatment]: The primary outcome is the proportion of participants who test negative for Clonorchis sinensis eggs in at least one stool sample collected 4 weeks after treatment.

Secondary outcomes

• Symptom Improvement Rate [Baseline and Week 4 after the last dose of treatment]: 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 at the Week 4 follow-up visit. A symptom is considered improved if its severity score decreases by at least 50% or if it has completely resolved by that follow-up visit.
• Adverse Events (AEs) [Baseline and Week 4 after the last dose of treatment]: Adverse events (AEs) will be collected from the initiation of treatment until the first follow-up visit. 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.
• Proportion of Abnormal Hematology and Liver Function Results [Baseline and Week 4 after the last dose of treatment]: Venous blood samples will be collected at baseline and follow-up 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.
• Drug Intolerance Rate [From first dose to Day 31 (+1 day) after the last dose of treatment]: 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.

Other outcomes

• Egg Clearance Rate After Second Treatment [Week 4 after the last dose of second treatment]: Among participants who remain egg-positive after the first treatment, a second course of the same antiparasitic regimen will be administered. Stool examinations will be performed 4 weeks after the second treatment.

Sex: All, ages: 18 Years to any

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.

• Hongliang Zhang, Principal investigator, First Affiliated Hospital of Guangxi Medical University