Treating clonorchiasis with albendazole, tribendimidine, or praziquantel in Guangxi
Albendazole, Tribendimidine, and Praziquantel for Clonorchiasis in Guangxi: A Randomized Controlled Trial Comparing Efficacy and Safety
We will test which of three medicines—albendazole, tribendimidine, or praziquantel—best clears liver fluke (Clonorchis sinensis) eggs from stool in adults with clonorchiasis and record side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Guangxi Medical University Academic / other |
| Locations | 2 sites (Nanning, Guangxi and 1 other locations) |
| Trial ID | NCT07074444 on ClinicalTrials.gov |
What this trial studies
This is a randomized, open-label trial comparing three commonly used antiparasitic drugs for adults with confirmed Clonorchis sinensis infection. Participants are randomly assigned to one of the three treatment regimens and provide stool samples before treatment and at follow-up to measure egg clearance. If eggs persist after the first course, the same regimen is repeated and stool is rechecked; adverse events are recorded throughout follow-up. The trial is conducted at two hospitals in Nanning, Guangxi, with standard clinical and laboratory monitoring.
Who should consider this trial
Good fit: Adults aged 18 or older with laboratory-confirmed Clonorchis sinensis infection who can provide informed consent and attend study visits are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have severe liver, kidney, or cardiac disease, gallstones or biliary obstruction, certain heart rhythm disorders, neuro/ocular cysticercosis, or known allergy to any study drug are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, the trial could identify the most effective and safest medicine among the three for clearing Clonorchis sinensis, helping to improve cure rates and guide local treatment choices.
How similar studies have performed: Praziquantel is an established effective treatment for clonorchiasis, tribendimidine has shown promise in smaller trials, and albendazole has been used but is less consistently studied for this infection.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nanning, Guangxi and 1 other locations
- People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (Not_yet_recruiting)
- The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
Study contacts
- Principal investigator: Hongliang Zhang — First Affiliated Hospital of Guangxi Medical University
- Study coordinator: Hongliang Zhang
- Email: 277749097@qq.com
- Phone: +86 13737143253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.