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.
- Conditions
- Health Condition 1: B550- Visceral leishmaniasis
- Registration Number
- CTRI/2022/11/047317
- Lead Sponsor
- Extramural project of RMRIMS ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The mentioned sample size (448) will be collected for our studyTimepoint: Period which may be needed for collecting the samples: 8 months
- Secondary Outcome Measures
Name Time Method The diagnostic and prognostic utility of Leish-LAMP assay kits will be validated on the basis of primary outcomes subjectsTimepoint: Period which may be needed for analysis the data: 4 months