The Chinese-made Praziquantel for Treatment of Schistosoma Haematobium

April 25, 2017 updated by: YANG KUN, Jiangsu Institute of Parasitic Diseases

Efficacy of Chinese-made Versus WHO-PQ Praziquantel for Treatment of Schistosoma Haematobium in Zanzibar: a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tanzania
    • Zanzibar
      • Pemba, Zanzibar, Tanzania
        • Recruiting
        • NTD office, Pemba,Ministry of Health, Zanzibar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Chinese-made praziquantel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After one month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After one and half month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Institute of Parasitic Diseases

Collaborators

World Health Organization

Investigators

  • Principal Investigator: Kun Yang, PHD, Jiangsu Institute of Parasitic Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2017

Primary Completion (Anticipated)

June 30, 2017

Study Completion (Anticipated)

July 10, 2017

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JIPD2017001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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