Post-kala-azar Dermal LeishmaniasisPhase 4NCT03311607
Safety and Effectiveness of Short-course AmBisome in the Treatment of PKDL in Bangladesh
A Phase 4 study testing AmBisome in people with Post-kala-azar Dermal Leishmaniasis, run by Medecins Sans Frontieres, Netherlands.
Trial summary
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Post-kala-azar Dermal Leishmaniasis
- What is being tested?
- AmBisome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2014to 14 Oct 2015
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test)
Who cannot join
- PKDL and concurrent VL
- Prior treatment for PKDL
- On medication with a side effect profile overlapping with that of AmBisome
- A known hypersensitivity to AmBisome
- Pregnant and lactating women,
- Known cardiac disease, hepatic impairment or another severe chronic underlying disease -Renal impairment (baseline serum creatinine > 1.3 mg/dL)
- Serum potassium <3.5mmol/L at baseline
About this study
Official title: Safety and Effectiveness of Short-course AmBisome in the Treatment of Post-Kala-azar Dermal Leishmaniasis (PKDL): a Prospective Cohort Study in Bangladesh
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.
Read the detailed description
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This was a prospective study, with the objective to assess final cure 12 months after treatment. Clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. A total of 280 patients recruited between 8 April and 25 November 2014 received AmBisome. Of these, 272 were assessed at 12 months.
- Conditions
- Post-kala-azar Dermal Leishmaniasis
- Being tested
- AmBisome
- Keywords
- Post-kala-azar Dermal Leishmaniasis, Visceral Leishmaniasis, AmBisome, Liposomal amphotericin B, Bangladesh, Kala azar
- Medical subject headings
- Leishmaniasis, Visceral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmBisomeDrug
A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule
| Study group | Role | What they receive |
|---|---|---|
| Cohort treated with AmBisome 15 mg/kg | Other | 280 patients, receiving AmBisome Receives: Drug: AmBisome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final outcome
The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline.
Measured: 12 months
Secondary outcomes (2)
Safety
Adverse events and serious adverse events were recorded during and up to one month after treatment.
Measured: 7 weeks
Hypokalaemia
Assessment of hypokalaemia was based on serum potassium, measured in blood samples taken at different times during and after treatment.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start8 Apr 2014
- Primary completion14 Oct 2015
- Study completion14 Oct 2015
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
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medecins Sans Frontieres, Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Koert Ritmeijer, PhD, Study director, Medecins Sans Frontieres, Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311607
- Sponsor's protocol ID
- MSF PKDL STUDY
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Short-course AmBisome in the Treatment of Post-Kala-azar Dermal Leishmaniasis (PKDL): a Prospective Cohort Study in Bangladesh
- ClinicalTrials.gov ID
- NCT03311607
- Acronym / sponsor ID
- MSF PKDL STUDY
- Conditions
- Post-kala-azar Dermal Leishmaniasis
- Keywords
- Post-kala-azar Dermal Leishmaniasis, Visceral Leishmaniasis, AmBisome, Liposomal amphotericin B, Bangladesh, Kala azar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Medecins Sans Frontieres, NetherlandsUniversity, hospital or other
- Study start
- 8 Apr 2014 (actual)
- Primary completion
- 14 Oct 2015 (actual)
- Study completion
- 14 Oct 2015 (actual)
- First posted
- 17 Oct 2017 (actual)
- 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.
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, is evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This is a prospective study, with the objective to assess final cure 12 months after treatment.
Detailed description
The safety and effectiveness of AmBisome 15 mg/kg, given over 15 days in 5 biweekly infusions of 3 mg/kg on an outpatient basis, was evaluated in clinically diagnosed PKDL patients of 12 years and older in a highly endemic area in Bangladesh. This was a prospective study, with the objective to assess final cure 12 months after treatment. Clinical response was monitored at 1, 3, 6, and 12 months after treatment, and safety during and up until one month after treatment. A total of 280 patients recruited between 8 April and 25 November 2014 received AmBisome. Of these, 272 were assessed at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Cohort treated with AmBisome 15 mg/kg | Other | Drug: AmBisome280 patients, receiving AmBisome |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients of 12 years and older with probable PKDL (skin lesions strongly suggestive of PKDL with exclusion of other skin diseases, a history of VL treatment and a positive serological rK39 test)
Key exclusion criteria (7 listed)
- PKDL and concurrent VL
- Prior treatment for PKDL
- On medication with a side effect profile overlapping with that of AmBisome
- A known hypersensitivity to AmBisome
- Pregnant and lactating women,
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 |
|---|---|---|
| AmBisomeA total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule | Drug | Cohort treated with AmBisome 15 mg/kg |
Primary outcome
Final outcome
Time frame: 12 months
The final outcome at 12 months was scored after carefully visual evaluation of the progress of all lesions of each patient compared to baseline.
2 secondary outcomes
Safety
Time frame: 7 weeks
Hypokalaemia
Time frame: 7 weeks
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 17 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Koert Ritmeijer, PhD study director
Medecins Sans Frontieres, Netherlands
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AmBisome in people with Post-kala-azar Dermal Leishmaniasis, run by Medecins Sans Frontieres, Netherlands.
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 1 inclusion and 7 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 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Final outcome (time frame: 12 months). 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 17 Oct 2017.