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Fast and reliable easy-to-use-diagnostics for eliminating Bilharzia in young children and mothers (freeBILy)

Fast and reliable easy-to-use-diagnostics for eliminating Bilharzia in young children and mothers (freeBILy)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR201905784271304
Enrollment
5200
Registered
2019-05-15
Start date
2018-12-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schistosomiasis

Interventions

Praziquantel

Sponsors

Bernhard Nocht Institute of Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Informed consent signed (from the parents for minors) - Expected residency in the area of the study site for the next 24 months - Pregnant women between their 5th and 6th months of pregnancy - Children born from an enrolled mother, including twins - Willingness to comply with the protocol requirements including: sampling and treatment for both mothers and children

Exclusion criteria

Exclusion criteria: - Fever (temporary exclusion) - History of transfusion - History of congenital anaemia - Epileptic or convulsive episodes - Non-pregnant women - Pregnant women younger than 16 years old - Pregnant women who have not completed their 4th month of pregnancy - Pregnant women over their 6th month of pregnancy - Pregnant women who do not live in the area of the CSB - Children born from mothers not enrolled in the study - Children born in a CSB different from the ones in which the mothers were enrolled

Design outcomes

Primary

MeasureTime frame
Height for age at 24 months will be used to measure the impact of TBST. Weight and height of children will be measured at birth, at 9 months and 24 months of age.;Maternal Hb at 24 months after delivery will be used to measure the impact of TBST. Maternal Hb will be measured at enrolment before delivery (8th month of pregnancy), 9 months after delivery and at two years after delivery.

Secondary

MeasureTime frame
Sensitivity and specificity of the POC-CCA test compared to the panel reference standard (measured in the cross-sectional study at Imerentsiatosika and Andina).;Prevalence of S. mansoni and S. haematobium in pregnant women and U5 children;Women’s quality of life related to health (measured by EQ-5D tool) and capacity to work and earn in routine activities;Costs of the interventions

Countries

Madagascar

Contacts

Public ContactDaniela Fusco

Group leader BNITM

fusco@bnitm.de+494042818503

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026