Contact information
Type
Scientific
Primary contact
Miss Lili Xu
ORCID ID
Contact details
207 Rui Jin Er Lu
Shanghai
200025
China
-
luckylilyxu@yahoo.com.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy and safety of praziquantel, tribendimidine and mebendazole in patients infected with Clonorchis sinensis: a single-centre, open-label, randomised controlled study
Acronym
Study hypothesis
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
Ethical Review Committee of the National Institute of Parasitic Diseases, China CDC, 29/04/2011, no. 2011042901
Study design
Single-centre open-label randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Praziquantel, tribendimidine, mebendazole, albendazole
Primary outcome measures
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 trial start date
25/06/2012
Overall trial end date
15/08/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120 participants
Participant 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
Recruitment start date
25/06/2012
Recruitment end date
15/08/2012
Locations
Countries of recruitment
China
Trial participating centre
207 Rui Jin Er Lu
Shanghai
200025
China
Sponsor information
Organisation
The National Institute of Parasitic Diseases (China)
Sponsor details
China CDC
207 Rui Jin Er Lu
Shanghai
200025
China
+86 (0)21 6437 7008
luckylilyxu@yahoo.com.cn
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Institute of Parasitic Diseases, China CDC (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25122121