Malaria,FalciparumHS-RDT-MiPNCT06572644
Performance of an Ultrasensible Malaria Rapid Diagnostic Test Among Pregnant Women in Burkina Faso
An observational study of Malaria,Falciparum, run by Centre MURAZ/Institut National de Santé Publique at 1 site in Burkina Faso.
Trial summary
The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test (HS-RDT) compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care (ANC) in Burkina Faso. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Malaria,Falciparum
- How many people
- 288 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 11 Oct 2022to 31 Dec 2023
- Phase
- Observational
- 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
Study population: Pregnant women attending their ANC visits at the Centre Médical Urbain de Lafiabougou
Who may be able to join
- Living in Bobo-Dioulasso for at least 6 months before the beginning of the study ;
- Provision of informed consent.
Who cannot join
- Past history of malaria or antimalarial drugs within the last 3 months ;
- Having tested positive for malaria by microscopy or RDT in any previous ANC visit ;
- Symptoms and signs of severe malaria as defined by WHO.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Centre Médical Urbain de Lafiabougou
Bobo-Dioulasso, Houet, 390
About this study
Official title: Evaluation of a Highly Sensitive Rapid Diagnostic Test for Detecting Falciparum Malaria Infection in Pregnancy in Burkina Faso
The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test (HS-RDT) compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care (ANC) in Burkina Faso. The main question it aims to answer is:
- What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction (qPCR) considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso ? Participants will be included during their ANC visits and screened for malaria using the HS_RDT, the conventional RDT (Co_RDT), microscopy, and qPCR.
Read the detailed description
A cross-sectional study including 288 pregnant women was conducted at the Centre médical urbain (CMU) of Lafiabougou located in the periurban area of Bobo-Dioulasso the second largest city of Burkina Faso. Pregnant women attending their ANC visits at the CMU of Lafiabougou were recruited and enrolled into the study if eligible criteria were fulfilled.
At enrolment, an individual structured questionnaire was administered to the selected pregnant women and their sociodemographic data (age, educational level, and profession) and history of illness was collected. In addition, obstetric history (parity, gestational age, number of ANC visits, uptake of IPTp-SP) and clinical information (body temperature, weight, height, and arm circumference) were recorded. Thereafter, a venous blood sample (5 mL) was collected to screen for malaria infection (based on HS-RDT, Co_RDT, and thick and thin blood smears), dried blood spots (DBS) (for molecular studies), and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.
After enrolment, only pregnant women eligible for their first IPTp-SP dose uptake was followed up for 30 days to assess the impact of IPTp-SP on both falciparum parasitaemia and falciparum resistant strains. At the end of follow up, a venous blood sample (5 mL) was collected for thick and thin blood smears, DBS, and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.
All biological samples was collected and stored at ambient temperature before being transported to the Laboratory of Parasitology of Centre MURAZ and processed.
The index tests included HS_RDT (NxTek Eliminate Malaria Pf, product code 05FK140, batch No. 05LDG008B, Alere/Abbott, Republic of Korea), Co_RDT (AdvDxTM Malaria Pf, product code 004ADFEF025KI-2, batch No. ADF77/0222, Advy Chemical, India), and light microscopy.
The ultrasensitive qPCR assay targeting the multicopy conserved var gene acidic terminal sequence (varATS) (Hofmann et al. 2015) was used as gold standard.
- Conditions
- Malaria,Falciparum
- Keywords
- Pregnancy, Malaria, Performance, Ultrasensible rapid diagnostic test, Burkina Faso
- Medical subject headings
- Malaria, Falciparum, Malaria
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of HS_RDT
It is defined as the proportion of positives that are correctly identified when compared with the gold standard (qPCR).
Measured: At baseline
Specificity of HS_RDT
It is defined as proportion of negatives that are correctly identified when compared with the gold standard (qPCR).
Measured: At baseline
Secondary outcomes (4)
Positive predictive value
Probability that P. falciparum infection is present when HS_RDT, Co_RDT, and microscopy are positive
Measured: At baseline
Negative predictive value
Probability that P. falciparum infection is not present when HS_RDT, Co_RDT, and microscopy are negative
Measured: At baseline
The prevalence of Pfhrp2 and Pfhrp3 genes deletions among the study participants
Proportion of pregnant women with malaria parasites carrying Pfhrp2/Pfhrp3 deletions
Measured: At baseline
Impact of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp- SP) on falciparum parasitaemia
Proportion of pregnant women with falciparum parasitaemia 30 days after uptake of IPTp-SP
Measured: 30 days after uptake of IPTp-SP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start11 Oct 2022
- Primary completion16 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre MURAZ/Institut National de Santé Publique
- Sponsor type
- Other government
- Collaborators
- University of Ghana
- Responsible party
- Principal investigator, Mamoudou Cissé, Centre MURAZ/Institut National de Santé Publique
- Investigators
- Mamoudou Cissé, MD, PhD, Principal investigator, Centre MURAZ/Institut National de Santé Publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572644
- Sponsor's protocol ID
- INSP_CM_09_2022
- Acronym
- HS-RDT-MiP
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Highly Sensitive Rapid Diagnostic Test for Detecting Falciparum Malaria Infection in Pregnancy in Burkina Faso
- ClinicalTrials.gov ID
- NCT06572644
- Acronym / sponsor ID
- HS-RDT-MiP / INSP_CM_09_2022
- Conditions
- Malaria,Falciparum
- Keywords
- Pregnancy, Malaria, Performance, Ultrasensible rapid diagnostic test, Burkina Faso
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Centre MURAZ/Institut National de Santé PubliqueOther government
- Collaborators
- University of Ghana
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Aug 2024 (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.
The goal of this observational study is to learn about the diagnostic performance of the highly sensitive rapid diagnostic test (HS-RDT) compared to an ultrasensitive qPCR for detection of falciparum malaria in pregnant women attending antenal care (ANC) in Burkina Faso. The main question it aims to answer is:
- What are the sensitivity and specificity of the HS-RDT compared to ultrasensitive quantitative polymerase chain reaction (qPCR) considered as gold standard for dection of falciparum malaria in pregnant women attending ANC in Burkina Faso ? Participants will be included during their ANC visits and screened for malaria using the HS_RDT, the conventional RDT (Co_RDT), microscopy, and qPCR.
Detailed description
A cross-sectional study including 288 pregnant women was conducted at the Centre médical urbain (CMU) of Lafiabougou located in the periurban area of Bobo-Dioulasso the second largest city of Burkina Faso. Pregnant women attending their ANC visits at the CMU of Lafiabougou were recruited and enrolled into the study if eligible criteria were fulfilled.
At enrolment, an individual structured questionnaire was administered to the selected pregnant women and their sociodemographic data (age, educational level, and profession) and history of illness was collected. In addition, obstetric history (parity, gestational age, number of ANC visits, uptake of IPTp-SP) and clinical information (body temperature, weight, height, and arm circumference) were recorded. Thereafter, a venous blood sample (5 mL) was collected to screen for malaria infection (based on HS-RDT, Co_RDT, and thick and thin blood smears), dried blood spots (DBS) (for molecular studies), and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.
After enrolment, only pregnant women eligible for their first IPTp-SP dose uptake was followed up for 30 days to assess the impact of IPTp-SP on both falciparum parasitaemia and falciparum resistant strains. At the end of follow up, a venous blood sample (5 mL) was collected for thick and thin blood smears, DBS, and haemoglobin concentration measurement. The remaining blood sample was stored for future studies.
All biological samples was collected and stored at ambient temperature before being transported to the Laboratory of Parasitology of Centre MURAZ and processed.
The index tests included HS_RDT (NxTek Eliminate Malaria Pf, product code 05FK140, batch No. 05LDG008B, Alere/Abbott, Republic of Korea), Co_RDT (AdvDxTM Malaria Pf, product code 004ADFEF025KI-2, batch No. ADF77/0222, Advy Chemical, India), and light microscopy.
The ultrasensitive qPCR assay targeting the multicopy conserved var gene acidic terminal sequence (varATS) (Hofmann et al. 2015) was used as gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women attending their ANC visits at the Centre Médical Urbain de Lafiabougou
Key inclusion criteria (2 listed)
- Living in Bobo-Dioulasso for at least 6 months before the beginning of the study ;
- Provision of informed consent.
Key exclusion criteria (3 listed)
- Past history of malaria or antimalarial drugs within the last 3 months ;
- Having tested positive for malaria by microscopy or RDT in any previous ANC visit ;
- Symptoms and signs of severe malaria as defined by WHO.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of HS_RDT
Time frame: At baseline
It is defined as the proportion of positives that are correctly identified when compared with the gold standard (qPCR).
Specificity of HS_RDT
Time frame: At baseline
It is defined as proportion of negatives that are correctly identified when compared with the gold standard (qPCR).
4 secondary outcomes
Positive predictive value
Time frame: At baseline
Negative predictive value
Time frame: At baseline
The prevalence of Pfhrp2 and Pfhrp3 genes deletions among the study participants
Time frame: At baseline
Impact of intermittent preventive treatment in pregnancy with sulfadoxine-pyrimethamine (IPTp- SP) on falciparum parasitaemia
Time frame: 30 days after uptake of IPTp-SP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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.
Mamoudou Cissé, MD, PhD principal investigator
Centre MURAZ/Institut National de Santé Publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria,Falciparum, run by Centre MURAZ/Institut National de Santé Publique at 1 site in Burkina Faso.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of HS_RDT (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2024.