Schistosomiasis Diagnosis Using a CAA Antigen Test

NCT03779347 | Unknown Phase 3 DMC

• 1 other identifier: FreebiLyGAB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Schistosomiasis Hematobium; Diagnostic; Drug Reaction; Pregnancy

Keywords

pregnancy, UPC-LF CAA, Schistosomiasis, children

Outcome Measures

Primary Outcomes (5)

• 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

• Egg reduction rate

  Egg reduction rate after PZQ treatment (sub-study B)

  first two years of the study

• CAA reduction rate

  CAA reduction and after PZQ treatment (sub-study B)

  first two years of the study

• 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

• 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 Outcomes (3)

• Clinical safety assessment upon PZQ intake

  anytime after drug administration until the last born child reach two years old.

• Efficacy rate using microscopy

  first two years of the study

• Efficacy rate using UCP-LF CAA test

  first two years of the study

Study Arms (3)

Schistosomiasis treated during pregnancy

EXPERIMENTAL

Praziquantel 40mg/kg once will be given during pregnancy at second to third trimester

Drug: Praziquantel

Schistosomiasis treated after pregnancy

ACTIVE COMPARATOR

Praziquantel 40mg/kg once will be given to parturient after delivery during lactation

Drug: Praziquantel

All study participants

EXPERIMENTAL

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

Diagnostic Test: UCP-LF CAA; Diagnostic Test: composite diagnostic

Interventions

Praziquantel DRUG

Praziquantel to treat schistosomiasis during pregnancy

Also known as: PZQ

Schistosomiasis treated after pregnancy; Schistosomiasis treated during pregnancy

UCP-LF CAA DIAGNOSTIC_TEST

UCP-LF CAA to diagnose Schistosomiasis during pregnancy

Also known as: CAA

All study participants

composite diagnostic DIAGNOSTIC_TEST

composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on egg DNA, and POC-CCA to diagnose Schistosomiasis during pregnancy

Also known as: Composite

All study participants

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Willing to move out of the study area within the coming 24 months
• Known having a medically confirmed complicated pregnancy a complicated pregnancy.

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead
• Universität Tübingen: collaborator

Study Sites (2)

Centre de Recherches Médicales de Lambaréné

Lambaréné, Moyen-Ogooué Province, BP 242, Gabon

NOT YET RECRUITING

Centre de Recherches Medicales de Lambaréné

Lambaréné, Gabon

RECRUITING

Related Publications (1)

• Honkpehedji YJ, Adegnika AA, Dejon-Agobe JC, Zinsou JF, Mba RB, Gerstenberg J, Rakotozandrindrainy R, Rakotoarivelo RA, Rasamoelina T, Sicuri E, Schwarz NG, Corstjens PLAM, Hoekstra PT, van Dam GJ, Kreidenweiss A; freeBILy Consortium. 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 Lambarene, Gabon: study protocol of the freeBILy clinical trial in Gabon. BMC Infect Dis. 2020 Sep 29;20(1):718. doi: 10.1186/s12879-020-05445-1.

  PMID: 32993559 DERIVED

MeSH Terms

Conditions

Disease; Drug-Related Side Effects and Adverse Reactions; Schistosomiasis

Interventions

Praziquantel

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ayola A ADEGNIKA, MD, PhD

  Centre de Recherches Médicales de Lambaréné (CERMEL)

  PRINCIPAL INVESTIGATOR

• Andrea Kreidenweiss, PhD

  University Hospital Tuebingen

  STUDY CHAIR

Central Study Contacts

Ayola A ADEGNIKA, MD, PhD

CONTACT

+24106244472; aadegnika@cermel.org

Josiane Y Honkpehedji, MD

CONTACT

+24104584616; hyjosy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 8, 2018
• First Posted: December 19, 2018
• Study Start: May 1, 2019
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

GA (2)