Post-kala-azar Dermal LeishmaniasisPhase 4NCT01975051
A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
A Phase 4 study testing Mitefosine in people with Post-kala-azar Dermal Leishmaniasis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL; anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its pathogenesis \& PKDL patients are genetically predisposed; diagnostic tool based on immunofluorescence technique will be more sensitive than… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-kala-azar Dermal Leishmaniasis
- What is being tested?
- Mitefosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2013to Sep 2014
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of Visceral Leishmaniasis
- Presence of hypopigmented rash
- Rk39 strip test positive
- Written informed consent from the participant
Who cannot join
- Any medical condition that may affect the safety of the patient during study procedure
- Any condition which comprises the ability to comply the study procedure
- Presence of splenomegaly
- Posotive skin smear for mycobacterium leprae
- Positive skin smear for fungus
- Pregnancy test positive
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL; anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its pathogenesis \& PKDL patients are genetically predisposed; diagnostic tool based on immunofluorescence technique will be more sensitive than slit skin examination for diagnosis of PKDL.
Read the detailed description
Background:Post-kala-azar dermal leishmaniasis is a skin disorder caused by the Leishmania donovani and usually develops after treatment for visceral leishmaniasis. The public health importance of this condition is that it plays as an inter-epidemic reservoir of visceral leishmaniasis.It is believed that the condition is associated with sodium stibogluconate (SSG) monotherapy for visceral leishmaniasis; however evidence is lacking to support this. Further no study has been carried out to explore the pathogenesis of PKDL in Bangladesh. Also no information is available related to development of PKDL after treatment of VL with miltefosine monotherapy in Bangladesh.Better knowledge on pathogenesis of PKDL will help to predict and design intervention to prevent the development of PKDL. This will help to reduce the numbers of inter-epidemic reservoir for VL and hence will contribute to the national kala-azar elimination program.
Objectives:1. To investigate the incidence of PKDL after SSG or Miltefosine mono-therapy for VL; 2. To investigate serum level of IL-10, TGF-β and markers of lipid metabolism (serum cholesterols) before and after treatment of PKDL; 3. To investigate the mRNA expression of IL-10, TGF-β in skin lesion of PKDL; 4. To investigate the association of gene polymorphism of IL-10, TGF-β and PKDL; 5. To develop a new diagnostic tool for diagnosis of PKDL by detection of LD antigen in the skin tissue by punch biopsy using immunofluorescence technique; and, 6. To investigate leishmania antigens and anti-leishmania antibodies in urine before and after treatment of PKDL and evaluate possibility to use them as diagnostic tools.
Methods:1. The incidence of PKDL after treatment for VL will be investigated through studying a retrospective cohort which will be identified by cross-sectional survey; 2. serum level of cytokines and lipid profile will be measured respectively by cytometric bed-array and autoanalyzer before and after treatment for PKDL; 3. mRNA expression of cytokines will be measured real-time PCR before and after treatment for PKDL; 4. gene polymorphism will be investigated by DNA sequencing; 5. the new diagnostic tool will be developed using immunofluorescence technique; and, 6. urine antigens and antibodies will be detected by ELISA.
- Conditions
- Post-kala-azar Dermal Leishmaniasis
- Being tested
- Mitefosine
- Keywords
- Kala- azar, PKDL, Treatment, Pathogenesis, Bangladesh
- Medical subject headings
- Leishmaniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitefosineDrug
Also called Brand name: Impavido
Tablet Miltefosine 100 mg in two devided doses for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Miltefosine | Experimental | Tablet Miltefosine 100 mg daily in two divided doses for 12 weeks. Receives: Drug: Mitefosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the association of treatment regimens for visceral leishmaniasis, host immunological, genetical and nutrition factors with Post-kala-azar Dermal Leishmaniasis (PKDL)
- PKDL burden among VL patients treated with SSG and miltefosine in the past; 2. Association of serum level of IL-10, TGF-β and serum level of cholesterols before and after treatment of PKDL; 3. mRNA expression of IL-10, TGF-β in skin lesion before and after treatment; 4. association of gene polymorphism of IL-10, TGF-β and PKDL; 5. diagnostic sensitivity of immunofluorescence technique compared to skin slit examination and PCR; and, 6. titer of urine antigens and antibodies before and after treatment of PKDL.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-kala-azar Dermal LeishmaniasisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nagasaki.
- Responsible party
- Sponsor
- Investigators
- Dinesh Mondal, MB; MD; PhD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975051
- Sponsor's protocol ID
- PR-12057
- Status last verified
- Nov 2012
- First submitted
- 23 Oct 2013
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Explore Association of Treatment Regimens for Visceral Leishmaniasis, Host Immunological, Genetical and Nutrition Factors With Post-kala-azar Dermal Leishmaniasis (PKDL)
- ClinicalTrials.gov ID
- NCT01975051
- Acronym / sponsor ID
- PR-12057
- Conditions
- Post-kala-azar Dermal Leishmaniasis
- Keywords
- Kala- azar, PKDL, Treatment, Pathogenesis, Bangladesh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of Nagasaki.
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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.
We hypothesize that PKDL develop after SSG as well as after Miltefosine mono-therapy for VL; anti-inflammatory cytokines such as IL-10, TGF-β, serum lipids play key role for its pathogenesis \& PKDL patients are genetically predisposed; diagnostic tool based on immunofluorescence technique will be more sensitive than slit skin examination for diagnosis of PKDL.
Detailed description
Background:Post-kala-azar dermal leishmaniasis is a skin disorder caused by the Leishmania donovani and usually develops after treatment for visceral leishmaniasis. The public health importance of this condition is that it plays as an inter-epidemic reservoir of visceral leishmaniasis.It is believed that the condition is associated with sodium stibogluconate (SSG) monotherapy for visceral leishmaniasis; however evidence is lacking to support this. Further no study has been carried out to explore the pathogenesis of PKDL in Bangladesh. Also no information is available related to development of PKDL after treatment of VL with miltefosine monotherapy in Bangladesh.Better knowledge on pathogenesis of PKDL will help to predict and design intervention to prevent the development of PKDL. This will help to reduce the numbers of inter-epidemic reservoir for VL and hence will contribute to the national kala-azar elimination program.
Objectives:1. To investigate the incidence of PKDL after SSG or Miltefosine mono-therapy for VL; 2. To investigate serum level of IL-10, TGF-β and markers of lipid metabolism (serum cholesterols) before and after treatment of PKDL; 3. To investigate the mRNA expression of IL-10, TGF-β in skin lesion of PKDL; 4. To investigate the association of gene polymorphism of IL-10, TGF-β and PKDL; 5. To develop a new diagnostic tool for diagnosis of PKDL by detection of LD antigen in the skin tissue by punch biopsy using immunofluorescence technique; and, 6. To investigate leishmania antigens and anti-leishmania antibodies in urine before and after treatment of PKDL and evaluate possibility to use them as diagnostic tools.
Methods:1. The incidence of PKDL after treatment for VL will be investigated through studying a retrospective cohort which will be identified by cross-sectional survey; 2. serum level of cytokines and lipid profile will be measured respectively by cytometric bed-array and autoanalyzer before and after treatment for PKDL; 3. mRNA expression of cytokines will be measured real-time PCR before and after treatment for PKDL; 4. gene polymorphism will be investigated by DNA sequencing; 5. the new diagnostic tool will be developed using immunofluorescence technique; and, 6. urine antigens and antibodies will be detected by ELISA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Miltefosine | Experimental | Drug: MitefosineTablet Miltefosine 100 mg daily in two divided doses for 12 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- History of Visceral Leishmaniasis
- Presence of hypopigmented rash
- Rk39 strip test positive
- Written informed consent from the participant
Key exclusion criteria (6 listed)
- Any medical condition that may affect the safety of the patient during study procedure
- Any condition which comprises the ability to comply the study procedure
- Presence of splenomegaly
- Posotive skin smear for mycobacterium leprae
- Positive skin smear for fungus
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 |
|---|---|---|
| MitefosineAlso: Brand name: ImpavidoTablet Miltefosine 100 mg in two devided doses for 12 weeks | Drug | Miltefosine |
Primary outcome
Explore the association of treatment regimens for visceral leishmaniasis, host immunological, genetical and nutrition factors with Post-kala-azar Dermal Leishmaniasis (PKDL)
Time frame: Three years
1. PKDL burden among VL patients treated with SSG and miltefosine in the past; 2. Association of serum level of IL-10, TGF-β and serum level of cholesterols before and after treatment of PKDL; 3. mRNA expression of IL-10, TGF-β in skin lesion before and after treatment; 4. association of gene polymorphism of IL-10, TGF-β and PKDL; 5. diagnostic sensitivity of immunofluorescence technique compared to skin slit examination and PCR; and, 6. titer of urine antigens and antibodies before and after treatment of PKDL.
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 5 Nov 2014.
Related trials for Post-kala-azar Dermal Leishmaniasis
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Skin and Connective Tissue Diseases, Neglected Tropical Diseases
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.
Dinesh Mondal, MB; MD; PhD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mitefosine in people with Post-kala-azar Dermal Leishmaniasis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 4 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Explore the association of treatment regimens for visceral leishmaniasis, host immunological, genetical and nutrition factors with Post-kala-azar Dermal Leishmaniasis (PKDL) (time frame: Three 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 5 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.