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The Chinese-made Praziquantel for Treatment of Schistosoma Haematobium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03133832
Recruitment Status : Unknown
Verified April 2017 by YANG KUN, Jiangsu Institute of Parasitic Diseases.
Recruitment status was:  Recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
YANG KUN, Jiangsu Institute of Parasitic Diseases

Brief Summary:

Schistosomiasis remains an important parasitic disease in the tropics, special in Africa including Zanzibar. The WHO-recommended strategy to eliminate schistosomiasis involves large-scale treatment of affected populations through periodic, targeted treatment of school-children with praziquantel. Donated praziquantel is the key to achieving elimination. The increase in the number of treatments is attributable to many factors, including improved availability of donated praziquantel, essentially from Merck; new countries starting to implement large-scale schistosomiasis control programmes; geographical scale-up of treatment within countries; and improved reporting to WHO. The global target set by WHO in the Roadmap on neglected tropical diseases is to attain at least 75% coverage of preventive chemotherapy in pre-school and school-age children by 2020. Experience from China demonstrates that preventive chemotherapy (that is, large scale treatment without individual diagnosis) with high coverage can significantly impact indices of infection and reduce transmission. The praziquantel made in China has been used from 1990s, and have effectively activity against S. haematobium, special the good economic benefits.

The project will propose to conduct an open-label, randomized trial to evaluate the comparative efficacy of Chinese-made Praziquantel versus WHO Praziquantel in the treatment of 200 people infected with S. haematobium in Pemba island Zanzibar. To do this the investigators will screen about 4000 people by examination of urine for schistosome eggs. Eligible participants will be randomized to receive a single dose of Chinese-made and WHO Praziquantel. Four weeks after treatment, the participants will be assessed for cure and egg reduction. The study may provide an alternative drug treatment for S. haematobium.


Condition or disease Intervention/treatment Phase
Schistosomiasis Haematobia Drug: Companion Tablet Phase 3

Detailed Description:

Participants There about 4000 peoples (aged 7-60 years) were enrolled from three Shehias in Pemba island Zanzibar. Urine will be collected and tested on April 2017. Eligible people will be enrolled based on the criteria of inclusion and exclusion. A series of meetings will be held at Shehias and schools to explain the objectives, procedures, and potential risks of the study.

Randomization Participants were randomly assigned (1:1) to receive Chinese-made versus WHO-PQ praziquantel. The randomization sequence was computer generated by the study sponsor. The staff of NTD office will give the assigned study drug after confirming the treatment allocation from the randomisation sequence. The NTD staff and and study participants will be unmasked to treatment assignment, but the laboratory technicians will be masked to treatment assignment throughout the study.

Procedures Firstly, every participant provided a fresh urine sample, which was used to detect the presence of S. haematobium. The NTD staff will do a physical examination, and checked the eligibility of every participant.

Participants whose urines tested positive for S. haematobium eggs and who met all eligibility criteria were invited to participate in the study.

Chines-made and WHO-PQ praziquantel will be give the participants one dose of 40 mg/kg per day. All study drugs were given orally, and the NTD staff will also record the exact time of drug ingestion.

Participants will be observed for 2 h after taking the drug to ensure retention and check for any immediate adverse events. If vomiting occurred within 2 h of drug ingestion, a second full dose was given.

After one month after enrolment, the follow-up visit will be provided, and urine will be collected and tested for S. haematobium eggs. As a quality control measure for inter-observer variability, a third technician reread a random selection of 10% of slides.

An adverse event is defined as a sign, symptom, intercurrent illness, or abnormal laboratory finding that just occurred during follow-up.

At the end of the study, all participants who have still excreting S. haematobium eggs (ie, not cured) will be treated with praziquantel again.

Statistical analysis There serial report forms will be used to data collection from participants, and Epi Info will be used to data enter.

The cure rate, the mean egg count and economic benefits will be analysed between the different group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Chinese-made Versus WHO-PQ Praziquantel for Treatment of Schistosoma Haematobium in Zanzibar: a Randomized Controlled Trial
Actual Study Start Date : April 10, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The cure rate between the two treatment
Compare the cure rate between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg
Drug: Companion Tablet
Chinese-made drug for schistosomiasis treatment
Other Name: Chinese-made praziquantel

Experimental: The amount of eggs produced
Compare the amount of eggs produced between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg
Drug: Companion Tablet
Chinese-made drug for schistosomiasis treatment
Other Name: Chinese-made praziquantel

Experimental: The economic benefit
Compare the economic benefit between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg
Drug: Companion Tablet
Chinese-made drug for schistosomiasis treatment
Other Name: Chinese-made praziquantel




Primary Outcome Measures :
  1. The cure rate of the two treatment [ Time Frame: After one month ]
    Collect urines from all participants for the group of Chinese-made and WHO-PQ praziquantel, test in the laboratory, calculate the proportion of patients cured, namely, the the cure rate. And then compare the cure rate between Chinese-made and WHO-PQ praziquantel.


Secondary Outcome Measures :
  1. The egg reduction of the two treatment [ Time Frame: After one month ]
    Collect urines from all participants for the group of Chinese-made and WHO-PQ praziquantel, test in the laboratory, get the account of eggs of each particpant, calculate the proportion of excreting S. haematobium eggs, and the egg reduction rate. And then compare the gg reduction rate between Chinese-made and WHO-PQ praziquantel.


Other Outcome Measures:
  1. The economic benefit of the two treatment [ Time Frame: After one and half month ]
    Collect questionnaires from all participants for the group of Chinese-made and WHO-PQ praziquantel, including the side effects, the cost of tables and deliver etc. And then compare the economic benefit between Chinese-made and WHO-PQ praziquantel.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 7 and 60 years old
  • Study participants appear healthy at enrollment
  • Suffering from S. haematobium infection, excreting eggs in urine
  • Residing in Pemba island, Zanzibar
  • Able to receive oral treatment
  • Assent to participate in study

Exclusion Criteria:

  • Pregnant or lactating at the time of the study
  • Presence of severe illness or malnutrition
  • Hypersensitivity to PZQ.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133832


Contacts
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Contact: Kun Yang, PHD +8613656190585 yangkun@jipd.com

Locations
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Tanzania
NTD office, Pemba,Ministry of Health, Zanzibar Recruiting
Pemba, Zanzibar, Tanzania
Contact: Saleh Juma, Master    +255 777 482 412    salehjuma2003@yahoo.com   
Sponsors and Collaborators
Jiangsu Institute of Parasitic Diseases
World Health Organization
Investigators
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Principal Investigator: Kun Yang, PHD Jiangsu Institute of Parasitic Diseases
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: YANG KUN, Deputy director, Jiangsu Institute of Parasitic Diseases
ClinicalTrials.gov Identifier: NCT03133832    
Other Study ID Numbers: JIPD2017001
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by YANG KUN, Jiangsu Institute of Parasitic Diseases:
Schistosomiasis haematobium
Praziquantel
A randomized controlled trial
Additional relevant MeSH terms:
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Schistosomiasis haematobia
Schistosomiasis
Trematode Infections
Helminthiasis
Parasitic Diseases
Urinary Tract Infections
Infection
Urologic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents