NCT03779347: FreebiLyGAB

Schistosomiasis Diagnosis Using a CAA Antigen Test

Status unknown Phase 3 Last updated 27 July 2021

What this trial tests

Phase 3 trial testing Praziquantel in Schistosomiasis Hematobium in 100 participants. Status unknown.

Timeline

1 May 2019

Primary endpoint
1 April 2022

1 May 2022

Quick facts

Lead sponsor	Centre de Recherche Médicale de Lambaréné
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	diagnostic
Enrollment	100
Start date	1 May 2019
Primary completion	1 April 2022
Estimated completion	1 May 2022
Sites	2 locations across Gabon

Drugs / interventions tested

• Praziquantel — full drug profile →
• UCP-LF CAA
• composite diagnostic

Conditions studied

• Schistosomiasis Hematobium — all drugs for Schistosomiasis Hematobium →
• Diagnostic — all drugs for Diagnostic →
• Drug Reaction — all drugs for Drug Reaction →
• Pregnancy — all drugs for Pregnancy →

Sponsor

Centre de Recherche Médicale de Lambaréné — full company profile →

Who can join

Eligibility, female only, with Schistosomiasis Hematobium or Diagnostic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Schistosomiasis is one of most important human parasitic diseases worldwide. Pregnant women and their infants are two vulnerable population groups, particularly in sub-Saharan Africa, where - amongst other infectious agents - they are heavily exposed to infections with S. haematobium. Adoption of the recommendation and implementation by national disease control programs was however delayed in most African countries, due to the lack of safety data in humans and in the unborn babies. First results from randomized controlled trials with PZQ in pregnant women meanwhile have provided evidence for the safety of PZQ also in newborns.

In Gabon, S. haematobium is the primarily prevalent Schistosoma species infection. As it is true for most of observational and interventional studies on schistosomiasis, the power of the study is weakened due to the low sensitivity of reference schistosomiasis diagnosis applied, and one might correctly assume that a considerable proportion of samples were misclassified as negative in the control groups. Therefore, diagnostic tests that are highly sensitive and specific are essential to the detection of Schistosoma infections and are urgently needed for a test-and-treat strategy to control schistosomiasis in pregnancy as well as tools to determine efficacy of new interventions tested in clinical trials. Circulating anodic antigen (CAA) and circulating cathodic antigen (CCA) have levels correlating with the number of worms and have also been shown to clear within a few days or weeks after successful treatment. Assays measuring serum levels of these antigens (POC-CCA, UCP-LF CAA) are therefore deemed to assess drug efficacy.

Based on above mentioned tools, we decided to assess the accuracy of CAA measurement to determine the Schistosoma infection in two specific conditions: A) as a diagnostic tool for S. haematobium to prepare for the future implementation of a PZQ test-and-treat strategy and B) as a diagnostic tool to measure efficacy of praziquantel in schistosomiasis and pregnancy intervention trials.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Human Placental Schistosomiasis-A Systematic Review of the Literature.
   Gerstenberg J, Mishra S, Holtfreter M, Richter J, et al · · 2024 · cited 9× · PMID 38921768 · DOI 10.3390/pathogens13060470
2. Prospective, observational study to assess the performance of CAA measurement as a diagnostic tool for the detection of Schistosoma haematobium infections in pregnant women and their child in Lambaréné, Gabon: study protocol of the freeBILy clinical trial in Gabon.
   Honkpehedji YJ, Adegnika AA, Dejon-Agobe JC, Zinsou JF, et al · · 2020 · cited 8× · PMID 32993559 · DOI 10.1186/s12879-020-05445-1