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Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya (rK28-AccDemo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05386875
Recruitment Status : Not yet recruiting
First Posted : May 23, 2022
Last Update Posted : May 23, 2022
Kenya Medical Research Institute
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:

Diagnosis of visceral leishmaniasis (VL) in eastern Africa is hampered by the availability of accurate diagnostic tests. Currently, diagnosis is based on testing suspected VL patients with the IT-Leish rK39 rapid diagnostic test (RDT) produced by Bio-Rad. If rK39 is negative on such patients, other tests such as the Direct Agglutination Tests (DAT) and microscopy of tissue aspirates (splenic, bone marrow, lymph node) are performed, following the recommended diagnostic algorithm by the Ministry of Health. The current diagnostic tools present several challenges. Simpler and easier to use tools are therefore needed.

A new VL RDT - OnSite Leishmania rK28 Ab Rapid Test (CTK Biotech), is available as a Research Use Only (RUO) test. The test may be easier to use, more stable at higher temperatures than the IT-Leish rK39 RDT, and cheaper. Results of clinical studies (AfriKADIA) comparing the performance of rK28 with IT-Leish rK39 in Kenya have shown higher sensitivity of rK28 (95.93%) but low specificity (72.73%) in blood, while the IT-Leish rK39 had sensitivity and specificity values of 91.87% and 100% respectively. Despite the lower specificity, the improved sensitivity of the rK28 could enable its use to rule-in VL in resource limited settings, when used in combination with current tools, thus enabling the early detection of additional cases. WHO recommends the availability of two RDTs. Generating more data on the use cases and advantages of rK28 would inform the WHO recommendation and its adoption. Furthermore, this data can contribute to its approval for use in Kenya, thereby improving methods for VL surveillance and control. With the recent announcement of the discontinuation of the IT-Leish rK39 by Bio-Rad, this study would also evaluate the Kalazar Detect rK39 (InBios) as an alternative to the IT-Leish rK39.

Condition or disease Intervention/treatment
Visceral Leishmaniasis Diagnostic Test: rK28

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Study Type : Observational
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : July 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Intervention Details:
  • Diagnostic Test: rK28
    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).

Primary Outcome Measures :
  1. Sensitivity and specificty [ Time Frame: 12 months ]
    Sensitivity and specificity of the VL diagnostic algorithm combining rK28 and rK39 (IT-Leish/Kalazar Detect) compared to rK39 (IT-Leish/Kalazar Detect) alone.

Secondary Outcome Measures :
  1. Number of cases [ Time Frame: 12 months ]
    Number of VL cases detected by the rK28 and rK39 alone.

  2. Cost effectivenes [ Time Frame: 12 months ]
    Cost of implementing diagnostic algorithms involving the use of rK28 in combination with rK39, compared to the normal algorithm with rK39 (IT-Leish/Kalazar Detect) alone.

Biospecimen Retention:   Samples Without DNA

Blood collection is part of the routine sampling procedure for VL diagnosis. Blood will be collected into heparinized tubes and tested immediately or stored at 4⁰C until used. Serum will be separated once blood aliquots are prepared (this is optional for this study, contingent on availability of tests). Dry blood spot (DBS) will also be collected for DAT testing. Blood aliquots, serum and DBS samples will be stored at -20⁰C at the study facility and later transferred to KEMRI, up to a maximum of 5 years. Stored samples will serve for quality control (QC) purposes.

The transfer of samples to any institution outside Kenya is not expected in this study. In the event that this may be required, the legal transfer will be regulated by material transfer agreements (MTA) or equivalent documents provided by FIND

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals presenting at health facilities in the participating sites or referred from peripheral health centres with suspicion of VL.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT05386875

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Contact: Dziedzom K de Souza +233244434966
Contact: Joseph Ndung'u +254 722 515 426 joseph.ndung'

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Turkana County
Lodwar, Kenya
Marsabit County
Marsabit, Kenya
Kenya Medical Research Institute
Nairobi, Kenya
Wajir County
Wajir, Kenya
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
Kenya Medical Research Institute
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Principal Investigator: Joseph Ndung'u Find
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland Identifier: NCT05386875    
Other Study ID Numbers: NT012
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leishmaniasis, Visceral
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Vector Borne Diseases
Skin Diseases, Infectious
Skin Diseases