Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya

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Brief Title

Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya

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

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.
    



Study Type

Observational


Primary Outcome

Sensitivity and specificty

Secondary Outcome

 Number of cases

Condition

Visceral Leishmaniasis

Intervention

rK28


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

1100

Start Date

July 1, 2022

Completion Date

July 31, 2023

Primary Completion Date

July 31, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

No

Contacts

Joseph Ndung'u, +233244434966, [email protected]

Location Countries

Kenya

Location Countries

Kenya

Administrative Informations


NCT ID

NCT05386875

Organization ID

NT012


Responsible Party

Sponsor

Study Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Collaborators

 Kenya Medical Research Institute

Study Sponsor

Joseph Ndung'u, Principal Investigator, Find


Verification Date

May 2022