Visceral LeishmaniasisrK28-AccDemoNCT05386875
Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya
An observational study of Visceral Leishmaniasis, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in Kenya.
Trial summary
Visceral leishmaniasis (VL) is a fatal disease caused by Leishmania parasites and transmitted by female phlebotomine sandflies. The disease is a serious public health problem in eastern Africa; including Kenya where an estimated 4000 cases occur annually and 5 million people are at risk of infection. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Visceral Leishmaniasis
- What is being tested?
- rK28
- How many people
- 625 participants
- Where
- 4 sitesKenya
- Study dates
- 31 Dec 2022to 30 Jun 2024
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals presenting at health facilities in the participating sites or referred from peripheral health centres with suspicion of VL.
Who may be able to join
- All patients ≥ 1 year, with clinical signs and symptoms compatible with VL (fever > 2 weeks, splenomegaly, wasting, malaria negative)
- Participants for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for participants under 18 years of age. In the case of minors 12 - 17 years, assent from the children will to be obtained in addition to parental consent.
Who cannot join
- Relapse cases of VL (recrudescent infection 6-12 month after treatment).
- Participants with post-kala-azar dermal leishmaniasis
- Participants from whom, for any reason, the blood sample needed for the evaluation cannot be taken
Trial locations and contacts
4 sites in 1 country.
Kenya4 sites, 3 recruiting
- Recruiting
Turkana County
Lodwar
Jimmy Loree
- Recruiting
Marsabit County
Marsabit
Abduba Liban
- Active, not recruiting
Kenya Medical Research Institute
Nairobi
- Recruiting
Wajir County
Wajir
Rukia Abdullahi
About this study
Official title: Evaluation of rK28 RDT for the Diagnosis of Visceral Leishmaniasis in Kenya, Towards Strengthening Recommendations for Its Use and Access in Eastern Africa
Visceral leishmaniasis (VL) is a fatal disease caused by Leishmania parasites and transmitted by female phlebotomine sandflies. The disease is a serious public health problem in eastern Africa; including Kenya where an estimated 4000 cases occur annually and 5 million people are at risk of infection. Accurate diagnosis of VL is critical for appropriate treatment. Currently, VL diagnosis in Kenya is based on testing suspected patients with the IT-Leish rK39 rapid diagnostic test (RDT) followed by other tests such as the Direct Agglutination Tests (DAT) and microscopy of tissue aspirates (splenic, bone marrow, lymph node) on rK39-negative patients. However, these diagnostic tools present several challenges including; the need for expertise, equipment and low diagnostic sensitivity of (85%) for DAT and rK39. Alternative VL diagnostic tools that are readily available, easy to use with increased sensitivity are needed to improve VL surveillance and control in Kenya. In the present study, we will assess rK28 as a diagnostic tool including performance with increased sensitivity when used together with IT-Leish rK39 and its potential for inclusion in VL diagnosis algorithms and evaluate Kala-azar Detect rK39 for potential use in Kenya. Suspected patients presenting at VL testing facilities in Marsabit, Turkana and Wajir Counties will be recruited prospectively and tested using IT-Leish rK39 followed by DAT for case confirmation according to the national guidelines. Alongside the case confirmation, samples from participants will also be tested using the rK28 and Kala-azar Detect rK39 in whole blood and serum. The collected data will be analyzed and compared separately between the RDTs as well as in combination, and the performance of the algorithms determined retrospectively. This design will enable the assessment of the sensitivity of combining rK28 and rK39 (Kala-azar Detect) compared to rK39 (IT-Leish/Kala-azar Detect) alone. Microscopy will be used as confirmatory test. We will also assess the feasibility, usefulness, and cost-effectiveness of rK28 in the VL diagnostic algorithm, through sensitivity analyses. The improved understanding of rK28 as a VL diagnostic tool and its potential for inclusion in the VL diagnosis algorithm could enable faster and more effective management of cases and accelerate elimination of VL.
- Conditions
- Visceral Leishmaniasis
- Being tested
- rK28
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rK28Diagnostic test
Also called IT-Leish rK39, KalazarDetect rK39
rK28 RDT (Index): The Leishmania Ab Rapid Test is a rapid immunochromatographic test that uses the recombinant antigen rK28 to detect antibodies against Leishmania species in human serum, plasma, or whole blood samples intended for primary VL diagnosis. It is a Research Use Only product commercialized by CTK Biotech, Inc. (USA).
IT-Leish rK39 RDT: Rapid immunochromatographic test for detection of antibodies against Leishmania species in human serum, plasma, or whole blood samples of utility in the VL diagnosis algorithm. It is a CE marked product commercialized by Bio-Rad (France). This is currently the recommended RDT for VL diagnosis in Kenya.
Kalazar Detect rK39, RDT: Rapid immunochromatographic test for detection of antibodies against Leishmania species in human serum, plasma, or whole blood samples of utility in the VL diagnosis algorithm. It is a CE marked product commercialized by InBios (United States).
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
Sensitivity, Specificity, the negative and positive predictive values (NPV, PPV) along with their confidence intervals.
Measured: 12 months
Diagnostic performance
Diagnostic odd ratio (DOR) or balanced Accuracy (BA).
Measured: 12 months
Use cases
Use cases for the different combination of tests.
Measured: 12 months
Secondary outcomes (2)
Cost effectiveness
Cost estimates per test/algorithm
Measured: 12 months
Access to diagnosis (optimum placement of RDTs)
Distance to the primary healthcare facility and to the referral facility.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start31 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral LeishmaniasisStudies 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
- Prospective
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Joseph Ndung'u, Principal investigator, Find
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386875
- Sponsor's protocol ID
- NT012
- Acronym
- rK28-AccDemo
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2022
- Last updated
- 7 Apr 2023
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of rK28 RDT for the Diagnosis of Visceral Leishmaniasis in Kenya, Towards Strengthening Recommendations for Its Use and Access in Eastern Africa
- ClinicalTrials.gov ID
- NCT05386875
- Acronym / sponsor ID
- rK28-AccDemo / NT012
- Conditions
- Visceral Leishmaniasis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 23 May 2022 (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.
Visceral leishmaniasis (VL) is a fatal disease caused by Leishmania parasites and transmitted by female phlebotomine sandflies. The disease is a serious public health problem in eastern Africa; including Kenya where an estimated 4000 cases occur annually and 5 million people are at risk of infection. Accurate diagnosis of VL is critical for appropriate treatment. Currently, VL diagnosis in Kenya is based on testing suspected patients with the IT-Leish rK39 rapid diagnostic test (RDT) followed by other tests such as the Direct Agglutination Tests (DAT) and microscopy of tissue aspirates (splenic, bone marrow, lymph node) on rK39-negative patients. However, these diagnostic tools present several challenges including; the need for expertise, equipment and low diagnostic sensitivity of (85%) for DAT and rK39. Alternative VL diagnostic tools that are readily available, easy to use with increased sensitivity are needed to improve VL surveillance and control in Kenya. In the present study, we will assess rK28 as a diagnostic tool including performance with increased sensitivity when used together with IT-Leish rK39 and its potential for inclusion in VL diagnosis algorithms and evaluate Kala-azar Detect rK39 for potential use in Kenya. Suspected patients presenting at VL testing facilities in Marsabit, Turkana and Wajir Counties will be recruited prospectively and tested using IT-Leish rK39 followed by DAT for case confirmation according to the national guidelines. Alongside the case confirmation, samples from participants will also be tested using the rK28 and Kala-azar Detect rK39 in whole blood and serum. The collected data will be analyzed and compared separately between the RDTs as well as in combination, and the performance of the algorithms determined retrospectively. This design will enable the assessment of the sensitivity of combining rK28 and rK39 (Kala-azar Detect) compared to rK39 (IT-Leish/Kala-azar Detect) alone. Microscopy will be used as confirmatory test. We will also assess the feasibility, usefulness, and cost-effectiveness of rK28 in the VL diagnostic algorithm, through sensitivity analyses. The improved understanding of rK28 as a VL diagnostic tool and its potential for inclusion in the VL diagnosis algorithm could enable faster and more effective management of cases and accelerate elimination of VL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals presenting at health facilities in the participating sites or referred from peripheral health centres with suspicion of VL.
Key inclusion criteria (2 listed)
- All patients ≥ 1 year, with clinical signs and symptoms compatible with VL (fever > 2 weeks, splenomegaly, wasting, malaria negative)
- Participants for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for participants under 18 years of age. In the case of minors 12 - 17 years, assent from the children will to be obtained in addition to parental consent.
Key exclusion criteria (3 listed)
- Relapse cases of VL (recrudescent infection 6-12 month after treatment).
- Participants with post-kala-azar dermal leishmaniasis
- Participants from whom, for any reason, the blood sample needed for the evaluation cannot be taken
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 |
|---|---|---|
| rK28Also: IT-Leish rK39, KalazarDetect rK39rK28 RDT (Index): The Leishmania Ab Rapid Test is a rapid immunochromatographic test that uses the recombinant antigen rK28 to detect antibodies against Leishmania species in human serum, plasma, or whole blood samples intended for primary VL diagnosis. It is a Research Use Only product commercialized by CTK Biotech, Inc. (USA). IT-Leish rK39 RDT: Rapid immunochromatographic test for detection of antibodies against Leishmania species in human serum, plasma, or whole blood samples of utility in the VL diagnosis algorithm. It is a CE marked product commercialized by Bio-Rad (France). This is currently the recommended RDT for VL diagnosis in Kenya. Kalazar Detect rK39, RDT: Rapid immunochromatographic test for detection of antibodies against Leishmania species in human serum, plasma, or whole blood samples of utility in the VL diagnosis algorithm. It is a CE marked product commercialized by InBios (United States). | Diagnostic test | – |
Primary outcome
Diagnostic performance
Time frame: 12 months
Sensitivity, Specificity, the negative and positive predictive values (NPV, PPV) along with their confidence intervals.
Diagnostic performance
Time frame: 12 months
Diagnostic odd ratio (DOR) or balanced Accuracy (BA).
Use cases
Time frame: 12 months
Use cases for the different combination of tests.
2 secondary outcomes
Cost effectiveness
Time frame: 12 months
Access to diagnosis (optimum placement of RDTs)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Related trials for Visceral Leishmaniasis
RecruitingObservational study
Diagnosis and Treatment of Leishmania Infections
Kinetoplastid, Skin Diseases, Parasitic
RecruitingObservational study
Ex Vivo Immunogenicity Screening of Vaccine Candidate Antigen Combinations in Ethiopian Patients With Leishmaniasis
Leishmaniasis, Cutaneous, Leishmaniasis
RecruitingObservational study
LEISH-PED: Study on Leishmaniasis in Children
Leishmania Infantum Disease, Leishmaniasis, Visceral
RecruitingObservational study
Recurrent Visceral Leishmaniasis in HIV Co-Infection
Hiv, Visceral Leishmaniasis
Active, not recruitingObservational study
A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Visceral Leishmaniasis
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.
Joseph Ndung'u principal investigator
Find
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Leishmaniasis, run by Foundation for Innovative New Diagnostics, Switzerland at 4 sites in Kenya.
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: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Kenya. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dawn K Maranga (+254722554641, Dawn.Maranga@finddx.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: 12 months). The study lists 3 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 7 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.