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To determine the occurrence of Post Kala-Azar Dermal Leishmaniasis (PKDL) in Visceral Leishmaniasis (VL) patients treated with new treatments in Bihar

Cohort observational study to estimate the prevalence of Post Kala-Azar Dermal Leishmaniasis (PKDL) in Visceral Leishmaniasis (VL) patients treated with three regimens in Bihar

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/06/007020
Enrollment
1761
Registered
2016-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Visceral Leishmaniasis (VL), also known as Kala Azar and Post Kala Azar Dermal Leishmaniasis patients

Interventions

None listed

Sponsors

Drugs for Neglected Diseases initiative DNDi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -All cases that have been previously diagnosed with sign and symptoms of Kala Azar and were rK 39 test or parasitology positive (by the time of the Kala Azar diagnosis) -All KA cases that have been previously treated with one of three regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin, Ambisome and Miltefosine combination over period Aug 2012 to Oct 2014 in pilot implementation study -Written voluntary informed consent to participate in the study

Exclusion criteria

Exclusion criteria: -Patients who are unwilling to participate in the study or guardian/Legal Acceptable Representative unwilling to provide written informed consent will be excluded from the study

Design outcomes

Primary

MeasureTime frame
To determine the prevalence rate of Post Kala Azar Dermal Leishmaniasis (PKDL) during or more than 24 months post treatment in Kala Azar treated cases with any of the three treatment regimens i.e. Single Dose Ambisome, combination of Miltefosine and Paromomycin for 10 days, Ambisome and Miltefosine for 8 daysTimepoint: Follow up of VL patients treated earlier for atleast 24 months after receiving VL treatment

Secondary

MeasureTime frame
To compare occurrence of PKDL in different treatment armsTimepoint: Follow up of treated patients for atleast 24 months;To determine the average time of occurrence of PKDL after each treatmentTimepoint: Follow up of patients for atleast 24 months

Countries

India

Contacts

Public ContactDr Suman Rijal

Drugs for Neglected Diseases initiative

vgoyal@dndi.org91-11-45501795

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026