| CTRI Number |
CTRI/2022/11/047317 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
26/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Currently, no point of care test is available for diagnosis of KA and PKDL with an assessment
of cure at community health center (CHC) level. Therefore, we will develop the first Indian LAMP assay kit for the above diagnosis. |
|
Scientific Title of Study
|
Field validation of Leish-LAMP detection kit for diagnosis of Kala-Azar (KA) and Post Kala-azar Dermal Leishmaniasis (PKDL) in endemic zone |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KRISHNA PANDEY |
| Designation |
DIRECTOR |
| Affiliation |
ICMR-RMRIMS, Patna |
| Address |
Director Office, RMRIMS, Agamkuan, Patna, Bihar, 800007 Director Office, RMRIMS, Agamkuan, Patna, Bihar, 800007 Patna BIHAR 800007 India |
| Phone |
8210353361 |
| Fax |
|
| Email |
drkrishnapandey@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
KRISHNA PANDEY |
| Designation |
DIRECTOR |
| Affiliation |
ICMR-RMRIMS, Patna |
| Address |
Director Office, RMRIMS, Agamkuan, Patna, Bihar, 800007 Director Office, RMRIMS, Agamkuan, Patna, Bihar, 800007 Patna BIHAR 800007 India |
| Phone |
8210353361 |
| Fax |
|
| Email |
drkrishnapandey@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
KRISHNA PANDEY |
| Designation |
DIRECTOR |
| Affiliation |
ICMR-RMRIMS, Patna |
| Address |
Director Office, RMRIMS, Agamkuan, Patna, Bihar, 800007 Director Office, RMRIMS, Agamkuan, Patna, Bihar, 800007 Patna BIHAR 800007 India |
| Phone |
8210353361 |
| Fax |
|
| Email |
drkrishnapandey@yahoo.com |
|
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Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Extramural project of RMRIMS ICMR |
| Address |
RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES AGAMKUAN PATNA - 800007 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishna Pandey |
RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES |
Department of Clinical Medicine, ICMR-RMRIMS, Agamkuan, Patna-07 Patna BIHAR |
9431042119
drkrishnapandey@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B550||Visceral leishmaniasis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged 5-65 years
2. Post kala azar dermal leishmaniasis (PKDL), parasitologically confirmed (amastigotes in slit-skin or snip skin smears and/or skin biopsies)
3. Macules, nodules and papules or plaques as clinical signs consistent with post Kala-azar dermal Leishmaniasis |
|
| ExclusionCriteria |
| Details |
1. Females not willing for contraception.
2. Patients not willing to participate.
3. Thrombocyte count <100 x 109/l
4. Leukocyte count <2.5 x 109/l
5. Hemoglobin < 8.0 g/100 ml
6. ASAT, ALAT, AP >3 times upper limit of normal range
7. Bilirubin >2 times upper limit of normal range
8. HbsAg, HCV and HIV positive
9. Serum creatinine or BUN >1.5 times upper limit of normal range
10. Hypersensitivity to miltefosine, paromomycin or inactive ingredients of miltefosine
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| The mentioned sample size (448) will be collected for our study |
Period which may be needed for collecting the samples: 8 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The diagnostic and prognostic utility of Leish-LAMP assay kits will be validated on the basis of primary outcomes subjects |
Period which may be needed for analysis the data: 4 months |
|
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Target Sample Size
|
Total Sample Size="448" Sample Size from India="448"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Published till date. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-kala-azar dermal Leishmaniasis (PKDL) is a complication of Kala-Azar (KA), characterized by macular, maculopapular, and nodular rashes in a patient who has recovered from KA. In the Indian subcontinent, PKDL is reported in 10–15% of patients treated for KA, usually after an interval of a few months to years. Diagnosis of KA and PKDL by microscopy needs an invasive/risky sample (bone marrow aspirate, splenic aspirate, tissue biopsy), culture test is tedious and time consuming with low sensitivity while RT-PCR is costly, and therefore these tests are not applicable at Community Health Centre (CHC) levels. Immunologic strip test (rK39 test) is inconclusive for KA relapse and PKDL cases due to presence of antibodies after KA. Also, immunological rK39 strip tests cannot be used for assessment of cure. Loop-mediated isothermal amplification (LAMP) assay is a novel molecular diagnostic method to amplify DNA with rapidity and high specificity under isothermal conditions. The LAMP assay is at the forefront in the search for innovative diagnostics for rapid and specific amplification of target DNA under isothermal conditions. Shorter reaction time with visual judgment of positivity without requiring sophisticated equipment makes it an attractive diagnostic method for field application. This will be the first Indian LAMP assay kit for the diagnosis of KA and PKDL. There is a dire need of such a ‘Make in India’ molecular diagnostic kit for the success of KA elimination program. Leish-LAMP detection kit may be used in India, Nepal and Bangladesh as the same L. donovani parasite is responsible for Leishmaniasis in these countries. Leish-LAMP assay can be performed with finger prick blood sample on filter paper, also known as Dried blood spot (DBS). |