SchistosomiasisSen_hybridsNCT04635553
Monitoring Schistosome Hybrids Under Under Praziquantel Pressure
An observational study of Schistosomiasis, run by Institut de Recherche pour le Developpement at 1 site in Senegal.
Trial summary
The overall objective of this project is to examine and quantify the potential existence and impact on Praziquantel (PZQ) efficacy, of naturally occurring S. haematobium and S. bovis hybrid populations in northern Senegal. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis
- What is being tested?
- Praziquantel 600 milligram
- How many people
- 250 participants
- Where
- 1 siteSenegal
- Study dates
- 11 Aug 2020to 31 Dec 2022
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Northern Senegal Children
Who may be able to join
- Children between the initiation courses (CI) and elementary course second year (CE2)
- Absence of declared chronic pathologies that could impact the follow-up
- Be positive for S. haematobium infection during the selection period (excreting eggs)
- Residing in the study area during the 3 years of the follow-up
Who cannot join
- Absence of written informed consent or expressed refusal from the child
- Enrolled in another on going study, which implicates the administration of PZQ or tests another product.
Trial locations and contacts
1 site in 1 country.
Senegal1 site, 1 recruiting
- Recruiting
Bruno SENGHOR
Dakar, 18524
Bruno SENGHOR, PhD, 776173437, bruno.senghor@ird.fr
Cheikh Sokhna, cheikh.sokhna@ird.fr
About this study
Official title: Prevalence of Potential Schistosome Hybrids and Their Invasive Capacity Under Praziquantel Pressure in Northern Senegal
The overall objective of this project is to examine and quantify the potential existence and impact on Praziquantel (PZQ) efficacy, of naturally occurring S. haematobium and S. bovis hybrid populations in northern Senegal. Schistosome hybrids may present vigor compared to their pure parental forms and hence, may be less sensitive to PZQ. We hypothesise that PZQ repeated treatment selects the hybrid schistosome populations.
Read the detailed description
Human schistosomiasis is a Neglected Tropical Disease caused by schistosome helminth worms with impressive epidemiological statistics associated: 800 million people at risk in 78 countries, > 230 million infected and > 200 000 deaths each year. The disease is highly endemic in sub-Saharan Africa where it persists despite mass drug administration with Praziquantel (PZQ). Some schistosomes are specific to humans and induce two main disease forms (either mesenteric or uro-genital) while others are associated with wild animals. However, hybridization can occur between different schistosome species. In northern Senegal, hybridization between schistosome species specific to humans and animals is now known to be frequent with the potential risk of zoonotic transmission.
This study will propose an integrative approach by conducting parasitological and molecular analysis including, schistosome miracidia genotyping to show if PZQ repeated treatment affects the genomic composition (Frequencies of alleles) of hybrid populations.
The objectives are:
- Determine the current prevalence of potential hybrid schistosome populations in their natural setting in Senegal
- Determine the sensitivity of hybrid schistosomes to praziquantel treatment in field populations
- Determine the molecular basis (at the genome level) of such phenotypic changes).
The study is a longitudinal observation of a cohort of school children after repeated Praziquantel (40 mg/kg) treatment, a drug commonly used through Mass Drug Administration (MDA) to treat schistosomiasis.
The cohort will be followed over a period of three years. Before the followup, a baseline urogenital schistosomiasis test will be performed on 1, 450 school-age children randomly selected in the five sites (290 in each site). All positive children will receive a single treatment (T1) of Praziquantel (PZQ) (40 mg/kg). Among those who test positive for S. haematobium eggs, only 50 in each site (five sites), who meet all the eligibility criteria will be invited to participate to the longitudinal follow-up. Four rounds of a single praziquantel (PZQ) treatment will be administered to positive individuals every 6 months. One round will consist of one treatment (T1 to T4) followed by a control treatment after one month (CT1 to CT4), hence, before the potential re-infecting schistosomes become adults and start egg-laying, which could bias the effectiveness of treatment evaluations. At each CT time, samples will be collected and S. haematobium eggs quantified (number of excreted eggs/10 mls of urine). Parasites (miracidia hatched from excreted eggs) will be recovered before each initial treatment (T1 to T4) and at CT1 to CT4 for subsequent genetic analysis to characterize hybrid schistosomes between S. haematobium and S. bovis.
- Conditions
- Schistosomiasis
- Being tested
- Praziquantel 600 milligram
- Medical subject headings
- Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Praziquantel 600 milligramDrug
A single treatment with a dose of 40 milligram/kilogram (mg/kg)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in prevalence and intensity of schistosome infection
Determine at the 1 month post treatment the cure rate (CR) of the treatments and Egg Reduction Rates (ERR).
Measured: December 31. 2020
Secondary outcomes (1)
Hybrids tolerance to praziquantel
The frequency of hybrids and the level of genomic introgression between S. bovis and S. haematobium
Measured: December 31, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start11 Aug 2020
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2022 (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 SchistosomiasisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635553
- Sponsor's protocol ID
- SEN2020-BS
- Acronym
- Sen_hybrids
- Status last verified
- Sep 2020
- First submitted
- 13 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Senghor B, Mathieu-Begne E, Rey O, Doucoure S, Sow D, Diop B, Sene M, Boissier J, Sokhna C. Urogenital schistosomiasis in three different water access in the Senegal river basin: prevalence and monitoring praziquantel efficacy and re-infection levels. BMC Infect Dis. 2022 Dec 29;22(1):968. doi: 10.1186/s12879-022-07813-5.
PubMed 36581796
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Potential Schistosome Hybrids and Their Invasive Capacity Under Praziquantel Pressure in Northern Senegal
- ClinicalTrials.gov ID
- NCT04635553
- Acronym / sponsor ID
- Sen_hybrids / SEN2020-BS
- Conditions
- Schistosomiasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Nov 2020 (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.
The overall objective of this project is to examine and quantify the potential existence and impact on Praziquantel (PZQ) efficacy, of naturally occurring S. haematobium and S. bovis hybrid populations in northern Senegal. Schistosome hybrids may present vigor compared to their pure parental forms and hence, may be less sensitive to PZQ. We hypothesise that PZQ repeated treatment selects the hybrid schistosome populations.
Detailed description
Human schistosomiasis is a Neglected Tropical Disease caused by schistosome helminth worms with impressive epidemiological statistics associated: 800 million people at risk in 78 countries, > 230 million infected and > 200 000 deaths each year. The disease is highly endemic in sub-Saharan Africa where it persists despite mass drug administration with Praziquantel (PZQ). Some schistosomes are specific to humans and induce two main disease forms (either mesenteric or uro-genital) while others are associated with wild animals. However, hybridization can occur between different schistosome species. In northern Senegal, hybridization between schistosome species specific to humans and animals is now known to be frequent with the potential risk of zoonotic transmission.
This study will propose an integrative approach by conducting parasitological and molecular analysis including, schistosome miracidia genotyping to show if PZQ repeated treatment affects the genomic composition (Frequencies of alleles) of hybrid populations.
The objectives are:
- Determine the current prevalence of potential hybrid schistosome populations in their natural setting in Senegal
- Determine the sensitivity of hybrid schistosomes to praziquantel treatment in field populations
- Determine the molecular basis (at the genome level) of such phenotypic changes).
The study is a longitudinal observation of a cohort of school children after repeated Praziquantel (40 mg/kg) treatment, a drug commonly used through Mass Drug Administration (MDA) to treat schistosomiasis.
The cohort will be followed over a period of three years. Before the followup, a baseline urogenital schistosomiasis test will be performed on 1, 450 school-age children randomly selected in the five sites (290 in each site). All positive children will receive a single treatment (T1) of Praziquantel (PZQ) (40 mg/kg). Among those who test positive for S. haematobium eggs, only 50 in each site (five sites), who meet all the eligibility criteria will be invited to participate to the longitudinal follow-up. Four rounds of a single praziquantel (PZQ) treatment will be administered to positive individuals every 6 months. One round will consist of one treatment (T1 to T4) followed by a control treatment after one month (CT1 to CT4), hence, before the potential re-infecting schistosomes become adults and start egg-laying, which could bias the effectiveness of treatment evaluations. At each CT time, samples will be collected and S. haematobium eggs quantified (number of excreted eggs/10 mls of urine). Parasites (miracidia hatched from excreted eggs) will be recovered before each initial treatment (T1 to T4) and at CT1 to CT4 for subsequent genetic analysis to characterize hybrid schistosomes between S. haematobium and S. bovis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Northern Senegal Children
Key inclusion criteria (4 listed)
- Children between the initiation courses (CI) and elementary course second year (CE2)
- Absence of declared chronic pathologies that could impact the follow-up
- Be positive for S. haematobium infection during the selection period (excreting eggs)
- Residing in the study area during the 3 years of the follow-up
Key exclusion criteria (2 listed)
- Absence of written informed consent or expressed refusal from the child
- Enrolled in another on going study, which implicates the administration of PZQ or tests another product.
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 |
|---|---|---|
| Praziquantel 600 milligramA single treatment with a dose of 40 milligram/kilogram (mg/kg) | Drug | – |
Primary outcome
Change from baseline in prevalence and intensity of schistosome infection
Time frame: December 31. 2020
Determine at the 1 month post treatment the cure rate (CR) of the treatments and Egg Reduction Rates (ERR).
1 secondary outcome
Hybrids tolerance to praziquantel
Time frame: December 31, 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Derived from this study: PubMed 36581796Senghor B, Mathieu-Begne E, Rey O, Doucoure S, Sow D, Diop B, Sene M, Boissier J, Sokhna C. Urogenital schistosomiasis in three different water access in the Senegal river basin: prevalence and monitoring praziquantel efficacy and re-infection levels. BMC Infect Dis. 2022 Dec 29;22(1):968. doi: 10.1186/s12879-022-07813-5.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis, run by Institut de Recherche pour le Developpement at 1 site in Senegal.
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 4 inclusion and 2 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 19 Nov 2020. 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 Senegal. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in prevalence and intensity of schistosome infection (time frame: December 31. 2020). 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 NCT04635553, 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 19 Nov 2020.