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Trial record 21 of 48 for:    ( Map: Gabon )

Schistosomiasis Diagnosis Using a CAA Antigen Test (FreebiLyGAB)

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ClinicalTrials.gov Identifier: NCT03779347
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
Universität Tübingen
Information provided by (Responsible Party):
Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné

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.


Condition or disease Intervention/treatment Phase
Schistosomiasis Hematobium Diagnostic Drug Reaction Pregnancy Drug: Praziquantel Diagnostic Test: UCP-LF CAA Diagnostic Test: composite diagnostic Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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
Primary Purpose: Diagnostic
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Schistosomiasis treated during pregnancy
Praziquantel 40mg/kg once will be given during pregnancy at second to third trimester
Drug: Praziquantel
Praziquantel to treat schistosomiasis during pregnancy
Other Name: PZQ

Active Comparator: Schistosomiasis treated after pregnancy
Praziquantel 40mg/kg once will be given to parturient after delivery during lactation
Drug: Praziquantel
Praziquantel to treat schistosomiasis during pregnancy
Other Name: PZQ

Experimental: All study participants
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
UCP-LF CAA to diagnose Schistosomiasis during pregnancy
Other Name: CAA

Diagnostic Test: composite diagnostic
composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on egg DNA, and POC-CCA to diagnose Schistosomiasis during pregnancy
Other Name: Composite




Primary Outcome Measures :
  1. UPC-LF CAA performance [ Time Frame: first two years of the study ]
    Test performance of the UCP-LF CAA test for the detection of S. haematobium infection in pregnancy (sub-study A)

  2. Egg reduction rate [ Time Frame: first two years of the study ]
    Egg reduction rate after PZQ treatment (sub-study B)

  3. CAA reduction rate [ Time Frame: first two years of the study ]
    CAA reduction and after PZQ treatment (sub-study B)

  4. Prevalence of S. hematobium in children using UCP-LF CAA [ Time Frame: last two years of the study ]
    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)

  5. Prevalence of S. hematobium in children using microscopy [ Time Frame: last two years of the study ]
    Prevalence of S. haematobium infections in infants below two years of age in our study areas as determined by egg microscopy


Secondary Outcome Measures :
  1. Clinical safety assessment upon PZQ intake [ Time Frame: anytime after drug administration until the last born child reach two years old. ]

    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

  2. Efficacy rate using microscopy [ Time Frame: first two years of the study ]
    PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by microscopy test

  3. Efficacy rate using UCP-LF CAA test [ Time Frame: first two years of the study ]
    PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by UCP-LF CAA test



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779347


Contacts
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Contact: Ayola A ADEGNIKA, MD, PhD +24106244472 aadegnika@cermel.org
Contact: Josiane Y Honkpehedji, MD +24104584616 hyjosy@gmail.com

Locations
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Gabon
Centre de Recherches Médicales de Lambaréné Not yet recruiting
Lambaréné, Moyen Ogooué, Gabon, BP 242
Contact: Ayola A ADEGNIKA, PhD    06244472    aadegnika@cermel.org   
Contact: Jean C Dejon, MD         
Centre de Recherches Medicales de Lambaréné Recruiting
Lambaréné, Gabon
Contact: Ayola A ADEGNIKA    +24106244472    aadegnika@cermel.org   
Sponsors and Collaborators
Centre de Recherche Médicale de Lambaréné
Universität Tübingen
Investigators
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Principal Investigator: Ayola A ADEGNIKA, MD, PhD Centre de Recherches Médicales de Lambaréné (CERMEL)
Study Chair: Andrea Kreidenweiss, PhD University Hospital Tuebingen

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Responsible Party: Prof. Ayola Akim ADEGNIKA, Director, Centre de Recherche Médicale de Lambaréné
ClinicalTrials.gov Identifier: NCT03779347     History of Changes
Other Study ID Numbers: FreebiLyGAB
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné:
pregnancy, UPC-LF CAA, Schistosomiasis, children
Additional relevant MeSH terms:
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Schistosomiasis haematobia
Schistosomiasis
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Trematode Infections
Helminthiasis
Parasitic Diseases
Urinary Tract Infections
Infection
Urologic Diseases
Praziquantel
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents