Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis
| ISRCTN | ISRCTN55086560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55086560 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/05/2011
- Registration date
- 19/05/2011
- Last edited
- 16/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Lili Xu
Scientific
Scientific
207 Rui Jin Er Lu
Shanghai
200025
China
| luckylilyxu@yahoo.com.cn |
Study information
| Study design | Single-centre open-label randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis: a single-centre, open-label, randomised controlled study |
| Study objectives | Clonorchiasis is one of important food-borne trematodiases which is highly prevalent in east and southeast Asia, especially in China, Korea, northern parts of Vietnam, and the far eastern part of Russia. Chemotherapy is the mainstay for the control of food-borne trematodiasis. Currently, praziquantel is the drug of choice for clonorchiasis. According to the recommendation from World Health Organisation (WHO), the appropriate treatment schedule is 25 mg/kg thrice daily for up to 2 days which results in cure rates of 94100% . Promotion of this dose schedule of praziquantel in mass treatment of clonorchiasis may have certain difficulty, while administration of single dose or reduction of treatment course results in less or unstable efficacy. Therefore, it still needs to develop the new drugs against C. sinensis. In recent years, we found that oral administration of single-dose tribendimidine and mebendazole and multiple-dose albendazole are efficacious. Tribendimidine exhibits not only potential effect against C. sinensis but also potential effect against juvenile C. sinensis. Albendazole was reported to be effective against C. sinensis in rats, and similar results were also shown in experimentally infected dogs. Up to 2005, an experimental study indicated that albendazole and mebendazole showed a potential effect against adult C. sinensis in rats and their single complete curative dose was 150 mg/kg. We aim to assess the efficacy and safety of tribendimidine, mebendazole and albendazole compared with that of praziquantel in patients with parasitologically confirmed Clonorchis sinensis. |
| Ethics approval(s) | Ethical Review Committee of the National Institute of Parasitic Diseases, China CDC, 29/04/2011, no. 2011042901 |
| Health condition(s) or problem(s) studied | Clonorchiasis |
| Intervention | Current interventions as of 14/08/2012: The intervention consists of four treatments, all the medicine is administered orally to each person 1. Multiple-dose praziquantel serves as control, and the total dose is 75 mg/kg (18.75mg/kg twice daily for two days consecutively). 2. Single-dose tribendimidine 400mg. 3. Two doses, on the same day, of Tribendimidine 200mg. The total dose is 400 mg. 4. Single-dose mebendazole 400mg. All the participants are supervised after treatments, and are asked to report any potential drug related symptoms at 3h and 24h after each time of taking medicine. Previous interventions until 14/08/2012: The intervention consists of four treatments, all the medicine is administered orally to each person 1. Multiple-dose praziquantel servers as control, and the total dose is 75 mg/kg(18.75mg/kg twice daily for 2 days consecutively) 2. Single-dose tribendimidine(400mg) 3. Multiple-dose mebendazole, and the total dose is 1500mg (500mg once daily for 3 days consecutively ) 4. Multiple-dose albendazole, the total dose is 3200mg( 400mg twice daily for 4 consecutive days). All the participants are supervised after treatments, and are asked to report any potential drug related symptoms at 24h, 48h, 72h, 96h, 120h and 144h after the first dose |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Praziquantel, tribendimidine, mebendazole, albendazole |
| Primary outcome measure | 1. Egg reduction rate (ERR) and cure rate (CR), measured using the Kato-Katz stool examination method 2. Adverse reactions, measured using a standardised questionnaire. The intensity of adverse events was graded as mild, moderate, severe and serious Assessed at 4 weeks after treatment |
| Secondary outcome measures | All the participants who are to receive the tribendimidine treatment will accept checks of blood, urine, electrocardiogram, liver function and kidney function before and after the treatment. The abnormal indexes will be supervised and recorded. |
| Overall study start date | 25/06/2012 |
| Completion date | 15/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 participants |
| Key inclusion criteria | Current inclusion criteria as of 14/08/2012: Eligible patients are residents of Hunan province aged 15 to 65 years who have Clonorchis sinensis infections, both sexes. Previous inclusion criteria until 14/08/2012: Eligible patients are residents of Guangdong province aged 2 years and above who had Clonorchis sinensis infections, both sexes |
| Key exclusion criteria | 1. Pregnant or lactating women 2. Presence of any abnormal medical condition, such as heart disease, high blood pressure, severe malnutrition, severe liver and kidney disease, psychiatric and neurologic disorders 3. Use of praziquantel , tribendimidine, albendazole and mebendazole or any anthelminthic treatment within the past month 4. Enrolled in any other clinical investigation during the study |
| Date of first enrolment | 25/06/2012 |
| Date of final enrolment | 15/08/2012 |
Locations
Countries of recruitment
- China
Study participating centre
207 Rui Jin Er Lu
Shanghai
200025
China
200025
China
Sponsor information
The National Institute of Parasitic Diseases (China)
Government
Government
China CDC
207 Rui Jin Er Lu
Shanghai
200025
China
| Phone | +86 (0)21 6437 7008 |
|---|---|
| luckylilyxu@yahoo.com.cn | |
"ROR" |
https://ror.org/04wktzw65 |
Funders
Funder type
Government
National Institute of Parasitic Diseases, China CDC (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/08/2014 | Yes | No |
Editorial Notes
On 17/01/2012 the overall trial start date was changed from 15/05/2011 to 15/02/2012 and the overall trial end date was changed from 15/07/2011 to 15/05/2012.
On 14/08/2012 this record was updated extensively to reflect a change in protocol:
1. The public title was changed from 'Efficacy and safety of praziquantel, tribendimidine, mebendazole and albendazole in patients infected with Clonorchis sinensis' to 'Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis'
2. The scientific title was changed from 'Efficacy and safety of praziquantel, tribendimidine, mebendazole and albendazole in patients infected with Clonorchis sinensis : a single-centre, open-label, randomised controlled study' to 'Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis : a single-centre, open-label, randomised controlled study'
3. The overall trial start date was changed from 15/02/2012 to 25/06/2012
4. The overall trial end date was changed from 15/05/2012 to 15/08/2012
5. The target number of participants was changed from 200 to 120
