Efficacy of albendazole in treatment of Clonorchis sinensis infection
| ISRCTN | ISRCTN46268871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46268871 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2024-009 |
| Sponsor | National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention (Chinese Center For Tropical Disease Research) |
| Funder | National Disease Control and Prevention Administration |
- Submission date
- 19/02/2025
- Registration date
- 27/02/2025
- Last edited
- 25/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This study focuses on a liver fluke called Clonorchis sinensis, which causes a disease known as clonorchiasis. Over 13 million people in China, South Korea, northern Vietnam, and far eastern Russia are infected. Currently, there is no vaccine, so treatment relies on a drug called praziquantel. However, there are concerns about drug resistance and side effects. This study aims to test another drug, albendazole, to see if it is effective and has fewer side effects.
Who can participate?
Adults aged 18-70 years who have been confirmed to be infected with Clonorchis sinensis can participate. The study will include 100 people, with 50 having a light infection and 50 having a moderate to heavy infection.
What does the study involve?
Participants will be randomly assigned to receive either praziquantel or albendazole. Those in the praziquantel group will take the drug three times a day for one day. Those in the albendazole group will take the drug twice a day for four days.
What are the possible benefits and risks of participating?
Participants may benefit from receiving treatment for their infection. However, there are risks of side effects from the drugs. Praziquantel is known to have higher rates of side effects, while albendazole is thought to have fewer side effects, but this is still being studied.
Where is the study run from?
National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention (Chinese Center For Tropical Disease Research), China.
When is the study starting and how long is it expected to run for?
November 2024 to June 2025.
Who is funding the study?
National Disease Control and Prevention Administration, China.
Who is the main contact?
Dr Men-Bao Qian, qianmb@nipd.chinacdc.cn
Contact information
Public, Scientific, Principal investigator
No. 207, Rui Jin Er Road
Shanghai
200025
China
 ORCID ID |
0000-0002-3027-2889 |
|---|---|
| Phone | +86-21-64739075 |
| qianmb@nipd.chinacdc.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized exploratory open-label phase II trial with two treatment arms |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Comparison on the efficacy of praziquantel and albendazole in treatment of Clonorchis sinensis infection |
| Study objectives | High dose of albendazole is comparable to praziquantel in treatment of Clonorchis sinensis infection |
| Ethics approval(s) |
Approved 20/11/2024, Ethical Review Committee of National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention (Chinese Center For Tropical Disease Research) (No. 207, Rui Jin Er Road, Shanghai, 200025, China; +86-21-54593271; lizhen@nipd.chinacdc.cn), ref: 2024-009 |
| Health condition(s) or problem(s) studied | Clonorchis sinensis infection |
| Intervention | Light infection (Eggs per gram of feces <1 000): Group 1: albendazole with a dose of 400 mg, twice a day for 4 days Group 2: praziquantel (25 mg/kg 3 times a day for 1 day) Moderate and heavy infection (Eggs per gram of feces ≥1 000): Group 1: albendazole with a dose of 400 mg, twice a day for 4 days Group 2: praziquantel (25 mg/kg 3 times a day for 1 day) Randomisation by sealed envelope. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | albendazole, praziquantel |
| Primary outcome measure(s) |
Cure rates and egg reduction rates three weeks after treatment: For diagnosis two stool samples will be collected before and after treatment. From each stool sample three Kato-Katz thick smears will be examined. |
| Key secondary outcome measure(s) |
Adverse events due to specific treatment: Participants will be monitored 3 hours and 24 hours after treatment with a standard questionnaire for adverse events. |
| Completion date | 20/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Patients (18-70 years) infected with C. sinensis, as assessed by the presence of eggs in the stool 2. Signed written informed consent 3. Able and willing to be examined by a study physician at the beginning of the study and at the end of study follow-up survey (3-4 weeks post-treatment) 4. Able and willing to provide multiple stool samples at the beginning and end of study 5. Absence of major systemic illnesses, psychiatric and neurological disorders as assessed by the medical doctor, upon initial clinical assessment 6. No known or reported hypersensitivity to albendazole or praziquantel 7. No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease 8. For females, not pregnant, as assessed by a female nurse (interview and pregnancy test if need be), upon initial clinical assessment |
| Key exclusion criteria | 1. For females, pregnancy 2. Presence of any abnormal medical condition, judged by the study physician 3. History of acute or severe chronic disease 4. Known or reported hypersensitivity to albendazole or praziquantel 5. Known or reported psychiatric or neurological disorders 6. Use of any anthelminthic within the past month 7. Attending other clinical trials during the study 8. Absence of signed written informed consent sheet |
| Date of first enrolment | 20/03/2025 |
| Date of final enrolment | 20/05/2025 |
Locations
Countries of recruitment
- China
Study participating centre
Nanning
530400
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon reasonable request from qianmb@nipd.chinacdc.cn |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/02/2025: Trial's existence confirmed by Ethical Review Committee of National Institute of Parasitic Diseases, Chinese Center for Disease Control and Prevention (Chinese Center For Tropical Disease Research).
