Schistosomiasis HematobiumPhase 3FreebiLyGABNCT03779347
Schistosomiasis Diagnosis Using a CAA Antigen Test
A Phase 3 study testing Praziquantel, UCP-LF CAA and composite diagnostic in people with Schistosomiasis Hematobium and Diagnostic, run by Centre de Recherche Médicale de Lambaréné at 2 sites in Gabon.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Schistosomiasis Hematobium, Diagnostic, Drug Reaction
- What is being tested?
- Praziquantel, UCP-LF CAA and composite diagnostic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesGabon
- Study dates
- 1 May 2019to 1 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - Willing to move out of the study area within the coming 24 months
- Known having a medically confirmed complicated pregnancy a complicated pregnancy.
Trial locations and contacts
2 sites in 1 country.
Gabon2 sites, 2 recruiting
- Not yet recruiting
Centre de Recherches Médicales de Lambaréné
Lambaréné, Moyen-Ogooué Province, BP 242
Ayola A ADEGNIKA, PhD, 06244472, aadegnika@cermel.org
Jean C Dejon, MD
- Recruiting
Centre de Recherches Medicales de Lambaréné
Lambaréné
Ayola A ADEGNIKA, +24106244472, aadegnika@cermel.org
About this study
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
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.
Read the detailed description
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.
- Conditions
- Schistosomiasis Hematobium, Diagnostic, Drug Reaction, Pregnancy
- Being tested
- Praziquantel, UCP-LF CAA, composite diagnostic
- Keywords
- pregnancy, UPC-LF CAA, Schistosomiasis, children
- Medical subject headings
- Disease, Drug-Related Side Effects and Adverse Reactions, Schistosomiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PraziquantelDrug
Also called PZQ
Praziquantel to treat schistosomiasis during pregnancy
UCP-LF CAADiagnostic test
Also called CAA
UCP-LF CAA to diagnose Schistosomiasis during pregnancy
composite diagnosticDiagnostic test
Also called Composite
composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on egg DNA, and POC-CCA to diagnose Schistosomiasis during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Schistosomiasis treated during pregnancy | Experimental | Praziquantel 40mg/kg once will be given during pregnancy at second to third trimester Receives: Drug: Praziquantel |
| Schistosomiasis treated after pregnancy | Active comparator | Praziquantel 40mg/kg once will be given to parturient after delivery during lactation Receives: 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 Receives: Diagnostic Test: UCP-LF CAA; Diagnostic Test: composite diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPC-LF CAA performance
Test performance of the UCP-LF CAA test for the detection of S. haematobium infection in pregnancy (sub-study A)
Measured: first two years of the study
Egg reduction rate
Egg reduction rate after PZQ treatment (sub-study B)
Measured: first two years of the study
CAA reduction rate
CAA reduction and after PZQ treatment (sub-study B)
Measured: 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)
Measured: 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
Measured: last two years of the study
Secondary outcomes (3)
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
Measured: anytime after drug administration until the last born child reach two years old.
Efficacy rate using microscopy
PZQ Cure rate for S. haematobium treatment in pregnancy (sub-study B) assessed by microscopy test
Measured: first two years of the study
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
Measured: first two years of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 May 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schistosomiasis HematobiumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Principal investigator, Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné
- Investigators
- Ayola A ADEGNIKA, MD, PhD, Principal investigator, Centre de Recherches Médicales de Lambaréné (CERMEL)Andrea Kreidenweiss, PhD, Study chair, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779347
- Sponsor's protocol ID
- FreebiLyGAB
- Acronym
- FreebiLyGAB
- Status last verified
- Jul 2021
- First submitted
- 8 Dec 2018
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32993559
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03779347
- Acronym / sponsor ID
- FreebiLyGAB / FreebiLyGAB
- Conditions
- Schistosomiasis Hematobium, Diagnostic, Drug Reaction, Pregnancy
- Keywords
- pregnancy, UPC-LF CAA, Schistosomiasis, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Schistosomiasis treated during pregnancy | Experimental | Drug: PraziquantelPraziquantel 40mg/kg once will be given during pregnancy at second to third trimester |
| Schistosomiasis treated after pregnancy | Active comparator | Drug: PraziquantelPraziquantel 40mg/kg once will be given to parturient after delivery during lactation |
| All study participants | Experimental | Diagnostic Test: UCP-LF CAA, Diagnostic Test: composite diagnosticUCP-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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- - Willing to move out of the study area within the coming 24 months
- Known having a medically confirmed complicated pregnancy a complicated pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PraziquantelAlso: PZQPraziquantel to treat schistosomiasis during pregnancy | Drug | Schistosomiasis treated after pregnancy, Schistosomiasis treated during pregnancy |
| UCP-LF CAAAlso: CAAUCP-LF CAA to diagnose Schistosomiasis during pregnancy | Diagnostic test | All study participants |
| composite diagnosticAlso: Compositecomposite diagnostic reference test based on extensive egg microscopy, serology, qPCR on egg DNA, and POC-CCA to diagnose Schistosomiasis during pregnancy | Diagnostic test | All study participants |
Primary outcome
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)
Egg reduction rate
Time frame: first two years of the study
Egg reduction rate after PZQ treatment (sub-study B)
CAA reduction rate
Time frame: first two years of the study
CAA reduction and after PZQ treatment (sub-study B)
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)
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
3 secondary outcomes
Clinical safety assessment upon PZQ intake
Time frame: anytime after drug administration until the last born child reach two years old.
Efficacy rate using microscopy
Time frame: first two years of the study
Efficacy rate using UCP-LF CAA test
Time frame: first two years of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 32993559Honkpehedji 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayola A ADEGNIKA, MD, PhD principal investigator
Centre de Recherches Médicales de Lambaréné (CERMEL)
Andrea Kreidenweiss, PhD study chair
University Hospital Tuebingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Praziquantel, UCP-LF CAA and composite diagnostic in people with Schistosomiasis Hematobium and Diagnostic, run by Centre de Recherche Médicale de Lambaréné at 2 sites in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayola A ADEGNIKA, MD, PhD (+24106244472, aadegnika@cermel.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPC-LF CAA performance (time frame: first two years of the study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779347, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.