Pregnancy Clinical Trial
— FreebiLyGABOfficial title:
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 Newborn and Child in Lambaréné, Gabon
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 1, 2022 |
Est. primary completion date | April 1, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Pregnant women with a gestational age comprised between 16 and 30 weeks (based on last date of menses) - Willing to deliver in one of the four maternities: three in Lambaréné and one in Fougamou - Provide a written informed consent for both themselves and for newborn follow-up or the written informed consent by the legal guardian if pregnant woman is a minor Exclusion Criteria: - - Willing to move out of the study area within the coming 24 months - Known having a medically confirmed complicated pregnancy a complicated pregnancy. |
Country | Name | City | State |
---|---|---|---|
Gabon | Centre de Recherches Medicales de Lambaréné | Lambaréné | |
Gabon | Centre de Recherches Médicales de Lambaréné | Lambaréné | Moyen Ogooué |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche Médicale de Lambaréné | Universität Tübingen |
Gabon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | UPC-LF CAA performance | Test performance of the UCP-LF CAA test for the detection of S. haematobium infection in pregnancy (sub-study A) | first two years of the study | |
Primary | Egg reduction rate | Egg reduction rate after PZQ treatment (sub-study B) | first two years of the study | |
Primary | CAA reduction rate | CAA reduction and after PZQ treatment (sub-study B) | first two years of the study | |
Primary | Prevalence of S. hematobium in children using UCP-LF CAA | Prevalence of S. haematobium infections in infants below two years of age in our study areas as determined by UCP-LF CAA test (sub-study C) | last two years of the study | |
Primary | Prevalence of S. hematobium in children using microscopy | Prevalence of S. haematobium infections in infants below two years of age in our study areas as determined by egg microscopy | last two years of the study | |
Secondary | Clinical safety assessment upon PZQ intake | Adverse events related and or unrelated to PZQ administration to pregnant women will be assessed clinically:
During pregnancy At delivery During the first two years of unborn child |
anytime after drug administration until the last born child reach two years old. | |
Secondary | Efficacy rate using microscopy | PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by microscopy test | first two years of the study | |
Secondary | Efficacy rate using UCP-LF CAA test | PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by UCP-LF CAA test | first two years of the study |
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