Schistosomiasis HaematobiaPhase 3NCT03133832
The Chinese-made Praziquantel for Treatment of Schistosoma Haematobium
A Phase 3 study testing Companion Tablet in people with Schistosomiasis Haematobia, run by Jiangsu Institute of Parasitic Diseases at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis Haematobia
- What is being tested?
- Companion Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTanzania
- Study dates
- 10 Apr 2017to 10 Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Pregnant or lactating at the time of the study
- Presence of severe illness or malnutrition
- Hypersensitivity to PZQ.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site, 1 recruiting
- Recruiting
NTD office, Pemba,Ministry of Health, Zanzibar
Pemba, Zanzibar
Saleh Juma, Master, +255 777 482 412, salehjuma2003@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Schistosomiasis Haematobia
- Being tested
- Companion Tablet
- Keywords
- Schistosomiasis haematobium, Praziquantel, A randomized controlled trial
- Medical subject headings
- Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Companion TabletDrug
Also called Chinese-made praziquantel
Chinese-made drug for schistosomiasis treatment
| Study group | Role | What they receive |
|---|---|---|
| The cure rate between the two treatment | Experimental | Compare the cure rate between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg Receives: Drug: Companion Tablet |
| The amount of eggs produced | Experimental | Compare the amount of eggs produced between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg Receives: Drug: Companion Tablet |
| The economic benefit | Experimental | Compare the economic benefit between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg Receives: Drug: Companion Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The cure rate of the two treatment
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.
Measured: After one month
Secondary outcomes (1)
The egg reduction of the two treatment
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.
Measured: After one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start10 Apr 2017
- Primary completion30 Jun 2017 (estimated)
- Study completion10 Jul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schistosomiasis HaematobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Institute of Parasitic Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Principal investigator, YANG KUN, Jiangsu Institute of Parasitic Diseases
- Investigators
- Kun Yang, PHD, Principal investigator, Jiangsu Institute of Parasitic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133832
- Sponsor's protocol ID
- JIPD2017001
- Status last verified
- Apr 2017
- First submitted
- 19 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang XY, He J, Juma S, Kabole F, Guo JG, Dai JR, Li W, Yang K. Efficacy of China-made praziquantel for treatment of Schistosomiasis haematobium in Africa: A randomized controlled trial. PLoS Negl Trop Dis. 2019 Apr 10;13(4):e0007238. doi: 10.1371/journal.pntd.0007238. eCollection 2019 Apr.
PubMed 30969960
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Chinese-made Versus WHO-PQ Praziquantel for Treatment of Schistosoma Haematobium in Zanzibar: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03133832
- Acronym / sponsor ID
- JIPD2017001
- Conditions
- Schistosomiasis Haematobia
- Keywords
- Schistosomiasis haematobium, Praziquantel, A randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jiangsu Institute of Parasitic DiseasesUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 10 Jul 2017 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The cure rate between the two treatment | Experimental | Drug: Companion TabletCompare the cure rate between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg |
| The amount of eggs produced | Experimental | Drug: Companion TabletCompare the amount of eggs produced between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg |
| The economic benefit | Experimental | Drug: Companion TabletCompare the economic benefit between the Chinese-made praziquantel and companion tablet at one dose of 40 mg/kg |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant or lactating at the time of the study
- Presence of severe illness or malnutrition
- Hypersensitivity to PZQ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Companion TabletAlso: Chinese-made praziquantelChinese-made drug for schistosomiasis treatment | Drug | The amount of eggs produced, The cure rate between the two treatment, The economic benefit |
Primary outcome
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.
1 secondary outcome
The egg reduction of the two treatment
Time frame: After one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 30969960Wang XY, He J, Juma S, Kabole F, Guo JG, Dai JR, Li W, Yang K. Efficacy of China-made praziquantel for treatment of Schistosomiasis haematobium in Africa: A randomized controlled trial. PLoS Negl Trop Dis. 2019 Apr 10;13(4):e0007238. doi: 10.1371/journal.pntd.0007238. eCollection 2019 Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun Yang, PHD principal investigator
Jiangsu Institute of Parasitic Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Companion Tablet in people with Schistosomiasis Haematobia, run by Jiangsu Institute of Parasitic Diseases at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Yang, PHD (+8613656190585, yangkun@jipd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The cure rate of the two treatment (time frame: After one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.