<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779347</url>
  </required_header>
  <id_info>
    <org_study_id>FreebiLyGAB</org_study_id>
    <nct_id>NCT03779347</nct_id>
  </id_info>
  <brief_title>Schistosomiasis Diagnosis Using a CAA Antigen Test</brief_title>
  <acronym>FreebiLyGAB</acronym>
  <official_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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre de Recherche Médicale de Lambaréné</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universität Tübingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre de Recherche Médicale de Lambaréné</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schistosomiasis is one of most important human parasitic diseases worldwide. Pregnant women&#xD;
      and their infants are two vulnerable population groups, particularly in sub-Saharan Africa,&#xD;
      where - amongst other infectious agents - they are heavily exposed to infections with S.&#xD;
      haematobium. Adoption of the recommendation and implementation by national disease control&#xD;
      programs was however delayed in most African countries, due to the lack of safety data in&#xD;
      humans and in the unborn babies. First results from randomized controlled trials with PZQ in&#xD;
      pregnant women meanwhile have provided evidence for the safety of PZQ also in newborns.&#xD;
&#xD;
      In Gabon, S. haematobium is the primarily prevalent Schistosoma species infection. As it is&#xD;
      true for most of observational and interventional studies on schistosomiasis, the power of&#xD;
      the study is weakened due to the low sensitivity of reference schistosomiasis diagnosis&#xD;
      applied, and one might correctly assume that a considerable proportion of samples were&#xD;
      misclassified as negative in the control groups. Therefore, diagnostic tests that are highly&#xD;
      sensitive and specific are essential to the detection of Schistosoma infections and are&#xD;
      urgently needed for a test-and-treat strategy to control schistosomiasis in pregnancy as well&#xD;
      as tools to determine efficacy of new interventions tested in clinical trials. Circulating&#xD;
      anodic antigen (CAA) and circulating cathodic antigen (CCA) have levels correlating with the&#xD;
      number of worms and have also been shown to clear within a few days or weeks after successful&#xD;
      treatment. Assays measuring serum levels of these antigens (POC-CCA, UCP-LF CAA) are&#xD;
      therefore deemed to assess drug efficacy.&#xD;
&#xD;
      Based on above mentioned tools, we decided to assess the accuracy of CAA measurement to&#xD;
      determine the Schistosoma infection in two specific conditions: A) as a diagnostic tool for&#xD;
      S. haematobium to prepare for the future implementation of a PZQ test-and-treat strategy and&#xD;
      B) as a diagnostic tool to measure efficacy of praziquantel in schistosomiasis and pregnancy&#xD;
      intervention trials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design&#xD;
&#xD;
      The freeBILy-GAB study is a set of interlinked prospective, observational studies conducted&#xD;
      in Gabon to comprehensively assess the performance of CAA measurement for the detection of S.&#xD;
      haematobium infections in pregnant women and infants. The study is composed of 3 sub-studies&#xD;
      each targeted to assess a specific objective (see figure 1 for a schematic trial design,&#xD;
      procedures and stages). The study activities will also contribute to safety reporting of PZQ&#xD;
      use in pregnant women.&#xD;
&#xD;
      Sub-study A: At baseline, a diagnostic study will be conducted that will also allow to select&#xD;
      sub-study B study participants. The approach is a prospective, cross-sectional, observational&#xD;
      study conducted in pregnant women to determine the sensitivity and specificity of the UCP-LF&#xD;
      CAA test for the detection of S. haematobium infections using urine samples. In the absence&#xD;
      of a sensitive reference standard test, the index test (UCP-LF CAA) will be compared against&#xD;
      a composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on&#xD;
      egg DNA, and POC-CCA. Sampling will include standardized urine collection of 3 consecutive&#xD;
      days for S. haematobium diagnosis by egg microscopy, UCP-LF CAA testing, qPCR, and POC-CCA,&#xD;
      one (1) stool sample (within the 3 days of urine sampling) to control for S. intercalatum and&#xD;
      soil-transmitted helminths infections, and 1 blood sample (within the 3 days of urine&#xD;
      sampling) to measure anti-Schistosoma antibodies and to detect any other parasitic infections&#xD;
      endemic in the region including filarial and Plasmodia spps. and to provide blood cell counts&#xD;
      and hemoglobin to assess pregnant women health status. The laboratory staff involved in&#xD;
      performing the laboratory assays using the new techniques will be trained prior to the start&#xD;
      of the study. Volunteers positive for any parasitic infection except filaria will be treated&#xD;
      for the respective parasitic infection (S. haematobium, STH and malaria parasites) following&#xD;
      national treatment guidelines. Women positive for S. haematobium by egg microscopy or UCP-LF&#xD;
      CAA at baseline will receive either PZQ treatment (1x 40 mg/kg) within 7 days after the third&#xD;
      urine sample (early PZQ treatment) or after delivery (late PZQ treatment) following an&#xD;
      allocation ratio of 3:1. The late PZQ treatment group serves as a safety control group of PZQ&#xD;
      administration to pregnant women and exposure of their offspring (s). Maternal and perinatal&#xD;
      safety and efficacy outcomes will be assessed. For efficacy in offspring, birthweight (with&#xD;
      low birthweight defined as weight at birth &lt;2.5 kg) and small gestational age (used as an&#xD;
      indicator for possible intrauterine growth restriction) will be investigated. In addition,&#xD;
      the exposure to PZQ during pregnancy will be evaluated in infants at the age of 12 and 24&#xD;
      months. For efficacy in mothers, maternal anemia (defined as Hb &lt; 11 g/dl) at inclusion and&#xD;
      at delivery will be investigated.&#xD;
&#xD;
      Sub-study B is an observational, follow-up study of pregnant women infected with S.&#xD;
      haematobium by egg microscopy and/or UCP-LF CAA test and treated with PZQ or intended for&#xD;
      late PZQ treatment (see sub-study A). The aim of this sub-study is to assess if the UCP-LF&#xD;
      CAA test can be used to evaluate treatment efficacy of PZQ during pregnancy. Women positive&#xD;
      for S. haematobium by egg microscopy and/or UCP-LF CAA test and treated with PZQ (see&#xD;
      sub-study A) will be actively followed-up. Urine will be collected on day 2, day 4 and day 6&#xD;
      after PZQ treatment to determine the kinetics of CAA decay and then once a week until both&#xD;
      egg microscopy as well UCP-LF CAA assay become negative but no longer than 6 weeks after PZQ&#xD;
      treatment.&#xD;
&#xD;
      Sub-study C is an observational, longitudinal study on mothers and their newborn babies. This&#xD;
      sub-study aims to determine the incidence of S. haematobium infections and age to first S.&#xD;
      haematobium infection in life time in infants born from mothers included in the study.&#xD;
      Therefore, between 6 and 24 months post-delivery, mother and her infant will be asked to&#xD;
      provide urine every three month until UCP-LF CAA test becomes positive for S. haematobium&#xD;
      detection. In addition a questionnaire addressing water contact of mother and infant will be&#xD;
      applied. If UCP-LF CAA test becomes positive, mothers will be treated with 1x 40 mg/kg PZQ.&#xD;
&#xD;
      Furthermore, outcome of PZQ treatment during pregnancy on infant development will be assessed&#xD;
      at the age of 12 and 24 months after delivery in the two groups (early and late PZQ treatment&#xD;
      groups). This allows for a comparison to the freeBILy-MAD study in Madagascar.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Study assessor /investigator will be blinded from the treatment allocation. Treatment for study participants will be given under the supervision of the trained nurses at the ANC, while the study assessor will assess participants for clinical events at the research center</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>UPC-LF CAA performance</measure>
    <time_frame>first two years of the study</time_frame>
    <description>Test performance of the UCP-LF CAA test for the detection of S. haematobium infection in pregnancy (sub-study A)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Egg reduction rate</measure>
    <time_frame>first two years of the study</time_frame>
    <description>Egg reduction rate after PZQ treatment (sub-study B)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CAA reduction rate</measure>
    <time_frame>first two years of the study</time_frame>
    <description>CAA reduction and after PZQ treatment (sub-study B)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of S. hematobium in children using UCP-LF CAA</measure>
    <time_frame>last two years of the study</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of S. hematobium in children using microscopy</measure>
    <time_frame>last two years of the study</time_frame>
    <description>Prevalence of S. haematobium infections in infants below two years of age in our study areas as determined by egg microscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical safety assessment upon PZQ intake</measure>
    <time_frame>anytime after drug administration until the last born child reach two years old.</time_frame>
    <description>Adverse events related and or unrelated to PZQ administration to pregnant women will be assessed clinically:&#xD;
During pregnancy&#xD;
At delivery&#xD;
During the first two years of unborn child</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy rate using microscopy</measure>
    <time_frame>first two years of the study</time_frame>
    <description>PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by microscopy test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy rate using UCP-LF CAA test</measure>
    <time_frame>first two years of the study</time_frame>
    <description>PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by UCP-LF CAA test</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Schistosomiasis Hematobium</condition>
  <condition>Diagnostic</condition>
  <condition>Drug Reaction</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Schistosomiasis treated during pregnancy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Praziquantel 40mg/kg once will be given during pregnancy at second to third trimester</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Schistosomiasis treated after pregnancy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Praziquantel 40mg/kg once will be given to parturient after delivery during lactation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>All study participants</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>UCP-LF CAA and composite diagnostic reference test based on extensive egg microscopy, plus serology, plus qPCR on egg DNA, and plus POC-CC will be used to detect schistosomiasis infection in pregnant women</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Praziquantel</intervention_name>
    <description>Praziquantel to treat schistosomiasis during pregnancy</description>
    <arm_group_label>Schistosomiasis treated after pregnancy</arm_group_label>
    <arm_group_label>Schistosomiasis treated during pregnancy</arm_group_label>
    <other_name>PZQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>UCP-LF CAA</intervention_name>
    <description>UCP-LF CAA to diagnose Schistosomiasis during pregnancy</description>
    <arm_group_label>All study participants</arm_group_label>
    <other_name>CAA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>composite diagnostic</intervention_name>
    <description>composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on egg DNA, and POC-CCA to diagnose Schistosomiasis during pregnancy</description>
    <arm_group_label>All study participants</arm_group_label>
    <other_name>Composite</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with a gestational age comprised between 16 and 30 weeks (based on last&#xD;
             date of menses)&#xD;
&#xD;
          -  Willing to deliver in one of the four maternities: three in Lambaréné and one in&#xD;
             Fougamou&#xD;
&#xD;
          -  Provide a written informed consent for both themselves and for newborn follow-up or&#xD;
             the written informed consent by the legal guardian if pregnant woman is a minor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Willing to move out of the study area within the coming 24 months&#xD;
&#xD;
          -  Known having a medically confirmed complicated pregnancy a complicated pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayola A ADEGNIKA, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre de Recherches Médicales de Lambaréné (CERMEL)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea Kreidenweiss, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Tuebingen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ayola A ADEGNIKA, MD, PhD</last_name>
    <phone>+24106244472</phone>
    <email>aadegnika@cermel.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Josiane Y Honkpehedji, MD</last_name>
    <phone>+24104584616</phone>
    <email>hyjosy@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de Recherches Médicales de Lambaréné</name>
      <address>
        <city>Lambaréné</city>
        <state>Moyen Ogooué</state>
        <zip>BP 242</zip>
        <country>Gabon</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ayola A ADEGNIKA, PhD</last_name>
      <phone>06244472</phone>
      <email>aadegnika@cermel.org</email>
    </contact>
    <contact_backup>
      <last_name>Jean C Dejon, MD</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Centre de Recherches Medicales de Lambaréné</name>
      <address>
        <city>Lambaréné</city>
        <country>Gabon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ayola A ADEGNIKA</last_name>
      <phone>+24106244472</phone>
      <email>aadegnika@cermel.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Gabon</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre de Recherche Médicale de Lambaréné</investigator_affiliation>
    <investigator_full_name>Prof. Ayola Akim ADEGNIKA</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>pregnancy, UPC-LF CAA, Schistosomiasis, children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schistosomiasis</mesh_term>
    <mesh_term>Schistosomiasis haematobia</mesh_term>
    <mesh_term>Drug-Related Side Effects and Adverse Reactions</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Praziquantel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779347
org study id: FreebiLyGAB
nct id: NCT03779347
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
Study design

      The freeBILy-GAB study is a set of interlinked prospective, observational studies conducted
      in Gabon to comprehensively assess the performance of CAA measurement for the detection of S.
      haematobium infections in pregnant women and infants. The study is composed of 3 sub-studies
      each targeted to assess a specific objective (see figure 1 for a schematic trial design,
      procedures and stages). The study activities will also contribute to safety reporting of PZQ
      use in pregnant women.

      Sub-study A: At baseline, a diagnostic study will be conducted that will also allow to select
      sub-study B study participants. The approach is a prospective, cross-sectional, observational
      study conducted in pregnant women to determine the sensitivity and specificity of the UCP-LF
      CAA test for the detection of S. haematobium infections using urine samples. In the absence
      of a sensitive reference standard test, the index test (UCP-LF CAA) will be compared against
      a composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on
      egg DNA, and POC-CCA. Sampling will include standardized urine collection of 3 consecutive
      days for S. haematobium diagnosis by egg microscopy, UCP-LF CAA testing, qPCR, and POC-CCA,
      one (1) stool sample (within the 3 days of urine sampling) to control for S. intercalatum and
      soil-transmitted helminths infections, and 1 blood sample (within the 3 days of urine
      sampling) to measure anti-Schistosoma antibodies and to detect any other parasitic infections
      endemic in the region including filarial and Plasmodia spps. and to provide blood cell counts
      and hemoglobin to assess pregnant women health status. The laboratory staff involved in
      performing the laboratory assays using the new techniques will be trained prior to the start
      of the study. Volunteers positive for any parasitic infection except filaria will be treated
      for the respective parasitic infection (S. haematobium, STH and malaria parasites) following
      national treatment guidelines. Women positive for S. haematobium by egg microscopy or UCP-LF
      CAA at baseline will receive either PZQ treatment (1x 40 mg/kg) within 7 days after the third
      urine sample (early PZQ treatment) or after delivery (late PZQ treatment) following an
      allocation ratio of 3:1. The late PZQ treatment group serves as a safety control group of PZQ
      administration to pregnant women and exposure of their offspring (s). Maternal and perinatal
      safety and efficacy outcomes will be assessed. For efficacy in offspring, birthweight (with
      low birthweight defined as weight at birth <2.5 kg) and small gestational age (used as an
      indicator for possible intrauterine growth restriction) will be investigated. In addition,
      the exposure to PZQ during pregnancy will be evaluated in infants at the age of 12 and 24
      months. For efficacy in mothers, maternal anemia (defined as Hb < 11 g/dl) at inclusion and
      at delivery will be investigated.

      Sub-study B is an observational, follow-up study of pregnant women infected with S.
      haematobium by egg microscopy and/or UCP-LF CAA test and treated with PZQ or intended for
      late PZQ treatment (see sub-study A). The aim of this sub-study is to assess if the UCP-LF
      CAA test can be used to evaluate treatment efficacy of PZQ during pregnancy. Women positive
      for S. haematobium by egg microscopy and/or UCP-LF CAA test and treated with PZQ (see
      sub-study A) will be actively followed-up. Urine will be collected on day 2, day 4 and day 6
      after PZQ treatment to determine the kinetics of CAA decay and then once a week until both
      egg microscopy as well UCP-LF CAA assay become negative but no longer than 6 weeks after PZQ
      treatment.

      Sub-study C is an observational, longitudinal study on mothers and their newborn babies. This
      sub-study aims to determine the incidence of S. haematobium infections and age to first S.
      haematobium infection in life time in infants born from mothers included in the study.
      Therefore, between 6 and 24 months post-delivery, mother and her infant will be asked to
      provide urine every three month until UCP-LF CAA test becomes positive for S. haematobium
      detection. In addition a questionnaire addressing water contact of mother and infant will be
      applied. If UCP-LF CAA test becomes positive, mothers will be treated with 1x 40 mg/kg PZQ.

      Furthermore, outcome of PZQ treatment during pregnancy on infant development will be assessed
      at the age of 12 and 24 months after delivery in the two groups (early and late PZQ treatment
      groups). This allows for a comparison to the freeBILy-MAD study in Madagascar.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Diagnostic
masking: Double (Investigator, Outcomes Assessor)
masking description: Study assessor /investigator will be blinded from the treatment allocation. Treatment for study participants will be given under the supervision of the trained nurses at the ANC, while the study assessor will assess participants for clinical events at the research center
measure: UPC-LF CAA performance
time frame: first two years of the study
description: Test performance of the UCP-LF CAA test for the detection of S. haematobium infection in pregnancy (sub-study A)
measure: Egg reduction rate
time frame: first two years of the study
description: Egg reduction rate after PZQ treatment (sub-study B)
measure: CAA reduction rate
time frame: first two years of the study
description: CAA reduction and after PZQ treatment (sub-study B)
measure: Prevalence of S. hematobium in children using UCP-LF CAA
time frame: last two years of the study
description: 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)
measure: Prevalence of S. hematobium in children using microscopy
time frame: last two years of the study
description: Prevalence of S. haematobium infections in infants below two years of age in our study areas as determined by egg microscopy
measure: Clinical safety assessment upon PZQ intake
time frame: anytime after drug administration until the last born child reach two years old.
description: 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
measure: Efficacy rate using microscopy
time frame: first two years of the study
description: PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by microscopy test
measure: Efficacy rate using UCP-LF CAA test
time frame: first two years of the study
description: PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by UCP-LF CAA test
arm group label: Schistosomiasis treated during pregnancy
arm group type: Experimental
description: Praziquantel 40mg/kg once will be given during pregnancy at second to third trimester
arm group label: Schistosomiasis treated after pregnancy
arm group type: Active Comparator
description: Praziquantel 40mg/kg once will be given to parturient after delivery during lactation
arm group label: All study participants
arm group type: Experimental
description: UCP-LF CAA and composite diagnostic reference test based on extensive egg microscopy, plus serology, plus qPCR on egg DNA, and plus POC-CC will be used to detect schistosomiasis infection in pregnant women
intervention type: Drug
intervention name: Praziquantel
description: Praziquantel to treat schistosomiasis during pregnancy
arm group label: Schistosomiasis treated after pregnancy
arm group label: Schistosomiasis treated during pregnancy
other name: PZQ
intervention type: Diagnostic Test
intervention name: UCP-LF CAA
description: UCP-LF CAA to diagnose Schistosomiasis during pregnancy
arm group label: All study participants
other name: CAA
intervention type: Diagnostic Test
intervention name: composite diagnostic
description: composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on egg DNA, and POC-CCA to diagnose Schistosomiasis during pregnancy
arm group label: All study participants
other name: Composite
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ayola A ADEGNIKA, MD, PhD
role: Principal Investigator
affiliation: Centre de Recherches Médicales de Lambaréné (CERMEL)
last name: Andrea Kreidenweiss, PhD
role: Study Chair
affiliation: University Hospital Tuebingen
last name: Ayola A ADEGNIKA, MD, PhD
phone: +24106244472
email: aadegnika@cermel.org
last name: Josiane Y Honkpehedji, MD
phone: +24104584616
email: hyjosy@gmail.com
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Gabon
responsible party type: Principal Investigator
investigator affiliation: Centre de Recherche Médicale de Lambaréné
investigator full name: Prof. Ayola Akim ADEGNIKA
investigator title: Director
mesh term: Schistosomiasis
mesh term: Schistosomiasis haematobia
mesh term: Drug-Related Side Effects and Adverse Reactions
mesh term: Praziquantel
sharing ipd: Undecided