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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   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
Source of Monetary or Material Support  
ICMR 
 
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 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RAJENDRA MEMORIAL RESEARCH INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B550||Visceral leishmaniasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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 
 
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 
 
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).
 
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