Leishmaniasis, VisceralVL-DX-EAFRNCT03646981
Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
An observational study of Leishmaniasis, Visceral, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 countries.
Trial summary
According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. Read more about this study
- Who is it for?
- Ages 4 to 100 years
- Conditions the study is for
- Leishmaniasis, Visceral
- What is being tested?
- Leishmania Ab Rapid Test (CTK, Biotech)
- Type of treatment
- Medical device
- How many people
- 704 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2019to 1 Dec 2021
- 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 4 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient reporting to the participating VL treatment centres in Ethiopia, Kenya, Sudan and Uganda and suspected with primary VL is eligible for inclusion in the study.
Who may be able to join
- Patient with clinical signs compatible with VL.
- Is a first VL episode suspected.
- Patient ≥ 5 years old (≥ 4 years old in Kenya).
- Patient from whom written informed consent can be obtained or signed by parent or legal guardian if patient is under 18 years of age. In the case of minors, assent from the children (12-17 years old in Ethiopia, Uganda and Sudan, and 13-17 years old in Kenya) will be obtained, as per country legal requirements.
- Clinical samples required VL diagnosis (peripheral blood, lymph node or bone marrow or spleen aspirate) can be obtained from the patient and patient shows willingness.
Who cannot join
- Patient already on treatment for VL.
- Patient is a suspected VL relapse case.
- Patient has had previous VL episodes.
- Patients < 5 years old (< 4 years old in Kenya).
- Pregnant woman.
- Patient has post/para-kala-azar dermal leishmaniasis (PKDL).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Ethiopia1 site
Leishmaniasis Research and Treatment Centre, Gondar University Hospital
Gonder, PO BOX 196
Kenya1 site
Kacheliba District Hospital
Kacheliba, West Pokot County, P.O Box 50 Kacheliba 30601
About this study
According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. The main approach for VL diagnosis involves antibody detection using the rK39 rapid diagnostic test (RDT) and alternatively the direct agglutination test (DAT) to confirm clinically suspected cases. Suspected cases with negative rK39 RDT and/or DAT results are referred to facilities where examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available. Unfortunately, the diagnostic performance of rK39 in eastern Africa is suboptimal, particularly in settings with a high VL/HIV co-infection rate. A recently developed RDT, based on the recombinant antigen rK28, may overcome this problem, with studies reporting better performance than the rK39. However, data are not definitive, as studies comparing rK28 RDTs with rK39 RDT are limited. Another recently developed RDT detects immunoglobulin G1 (IgG1) specific to Leishmania and has shown promising results in the Indian subcontinent. This study aims to undertake a multi-country assessment of the performance of rK28 and IgG1 RDTs, as compared to the currently used rK39 RDT.
Read the detailed description
Primary objective and endpoint: To evaluate the performance of different diagnostic tests in detecting anti-Leishmania antibodies to improve early diagnosis of VL in eastern Africa, in particular Ethiopia, and Kenya. Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests.
Design: Prospective single arm diagnostic accuracy study. Multicountry. With participants being suspected cases of VL
- Conditions
- Leishmaniasis, Visceral
- Being tested
- Leishmania Ab Rapid Test (CTK, Biotech)
- Keywords
- visceral leishmaniasis, diagnostics, RDT, Eastern Africa
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leishmania Ab Rapid Test (CTK, Biotech)Device
Also called IT Leish (Bio Rad), IgG1 RDT (Coris BioConcept)
Rapid diagnostic tests to detect antibodies anti-Leishmania
What is being measured
The primary outcome is the main question the study is designed to answer.
RDT performance
Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests
Measured: an average of 1.5 years
Secondary outcomes (2)
Time to diagnosis
Time taken to perform each diagnostic test, measured from the time the patient reports at the health facility to the time diagnosis is made is established.
Measured: an average of 1.5 years
New diagnostic algorithm
The data generated will be analysed to assess whether the evaluated RDTs can be combined in a new algorithm to improve and accelerate VL diagnosis
Measured: an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2019
- Primary completion30 Oct 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leishmaniasis, VisceralStudies 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
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar, Kenya Medical Research Institute, London School of Hygiene and Tropical Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Drugs for Neglected Diseases
- Responsible party
- Sponsor
- Investigators
- Israel Cruz, PhD, Principal investigator, Find
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646981
- Sponsor's protocol ID
- P08002-VL-DX-EAFR
- Acronym
- VL-DX-EAFR
- Status last verified
- Jun 2022
- First submitted
- 7 Aug 2018
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing procedures (including data confidentiality) will be carried out in accordance with the regulations defined by IDDO and H2020 Open Research Data Pilot
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antibody Detection Tests for Visceral Leishmaniasis Diagnosis in Eastern Africa
- ClinicalTrials.gov ID
- NCT03646981
- Acronym / sponsor ID
- VL-DX-EAFR / P08002-VL-DX-EAFR
- Conditions
- Leishmaniasis, Visceral
- Keywords
- visceral leishmaniasis, diagnostics, RDT, Eastern Africa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Foundation for Innovative New Diagnostics, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Gondar, Kenya Medical Research Institute, London School of Hygiene and Tropical Medicine, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Drugs for Neglected Diseases
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Aug 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.
According to recent estimates by the World Health Organization (WHO) on eastern Africa, not all visceral leishmaniasis (VL) cases reported are confirmed by a laboratory test, probably due to limited access to accurate diagnostic tests and poor reporting. The main approach for VL diagnosis involves antibody detection using the rK39 rapid diagnostic test (RDT) and alternatively the direct agglutination test (DAT) to confirm clinically suspected cases. Suspected cases with negative rK39 RDT and/or DAT results are referred to facilities where examination of tissue aspirate (spleen, bone marrow, lymph node) by microscopy is available. Unfortunately, the diagnostic performance of rK39 in eastern Africa is suboptimal, particularly in settings with a high VL/HIV co-infection rate. A recently developed RDT, based on the recombinant antigen rK28, may overcome this problem, with studies reporting better performance than the rK39. However, data are not definitive, as studies comparing rK28 RDTs with rK39 RDT are limited. Another recently developed RDT detects immunoglobulin G1 (IgG1) specific to Leishmania and has shown promising results in the Indian subcontinent. This study aims to undertake a multi-country assessment of the performance of rK28 and IgG1 RDTs, as compared to the currently used rK39 RDT.
Detailed description
Primary objective and endpoint: To evaluate the performance of different diagnostic tests in detecting anti-Leishmania antibodies to improve early diagnosis of VL in eastern Africa, in particular Ethiopia, and Kenya. Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests.
Design: Prospective single arm diagnostic accuracy study. Multicountry. With participants being suspected cases of VL
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient reporting to the participating VL treatment centres in Ethiopia, Kenya, Sudan and Uganda and suspected with primary VL is eligible for inclusion in the study.
Key inclusion criteria (5 listed)
- Patient with clinical signs compatible with VL.
- Is a first VL episode suspected.
- Patient ≥ 5 years old (≥ 4 years old in Kenya).
- Patient from whom written informed consent can be obtained or signed by parent or legal guardian if patient is under 18 years of age. In the case of minors, assent from the children (12-17 years old in Ethiopia, Uganda and Sudan, and 13-17 years old in Kenya) will be obtained, as per country legal requirements.
- Clinical samples required VL diagnosis (peripheral blood, lymph node or bone marrow or spleen aspirate) can be obtained from the patient and patient shows willingness.
Key exclusion criteria (6 listed)
- Patient already on treatment for VL.
- Patient is a suspected VL relapse case.
- Patient has had previous VL episodes.
- Patients < 5 years old (< 4 years old in Kenya).
- Pregnant woman.
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 |
|---|---|---|
| Leishmania Ab Rapid Test (CTK, Biotech)Also: IT Leish (Bio Rad), IgG1 RDT (Coris BioConcept)Rapid diagnostic tests to detect antibodies anti-Leishmania | Device | – |
Primary outcome
RDT performance
Time frame: an average of 1.5 years
Evaluation of the diagnostic performance of the RDTs for primary VL diagnosis based on estimates of sensitivity, specificity, positive and negative predictive values, as well as the degree of agreement between tests
2 secondary outcomes
Time to diagnosis
Time frame: an average of 1.5 years
New diagnostic algorithm
Time frame: an average of 1.5 years
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 6 Jun 2022.
- Individual participant dataSharing planned: Undecided. Data sharing procedures (including data confidentiality) will be carried out in accordance with the regulations defined by IDDO and H2020 Open Research Data Pilot
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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.
Israel Cruz, PhD principal investigator
Find
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leishmaniasis, Visceral, run by Foundation for Innovative New Diagnostics, Switzerland at 2 sites in 2 countries.
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 5 inclusion and 6 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 6 Jun 2022. 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 Ethiopia, 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?
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?
RDT performance (time frame: an average of 1.5 years). 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 6 Jun 2022.