NCT04635553

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 19, 2020

Status Verified

September 1, 2020

Enrollment Period

12 months

First QC Date

November 13, 2020

Last Update Submit

November 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    December 31. 2020

Secondary Outcomes (1)

  • Hybrids tolerance to praziquantel

    December 31, 2021

Interventions

A single treatment with a dose of 40 milligram/kilogram (mg/kg)

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Northern Senegal Children

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruno SENGHOR

Dakar, 18524, Senegal

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Schistosome miracidia

MeSH Terms

Conditions

Schistosomiasis

Condition Hierarchy (Ancestors)

Trematode InfectionsHelminthiasisParasitic DiseasesInfectionsVector Borne Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 19, 2020

Study Start

August 11, 2020

Primary Completion

July 31, 2021

Study Completion

December 31, 2022

Last Updated

November 19, 2020

Record last verified: 2020-09

Locations