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CompletedNCT03445897Updated Feb 27, 2018

Miltefosine Plus IL Pentamidine for Bolivian CL

A Phase 2 interventional study of miltefosine plus intralesional pentamidine in Leishmaniasis, Cutaneous, sponsored by Jonathan Berman. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by Jonathan Berman · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

Read the detailed description

Bolivian cutaneous leishmaniasis due to Leishmania braziliensis was treated with the combination of miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5). Efficacy and tolerance parameters were assessed. Efficacy was assessed at 1, 3, and 6 months post therapy. Tolerance was assessed on each day therapy was administered.

02

Conditions studied

  • Leishmaniasis, Cutaneous
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • one ulcerative lesion ≤ 900 mm2 in total area,
  • ≥ 12 years,
  • parasitologically diagnosed by visualization of amastigotes or culture of promastigotes from lesion material,
  • no antileishmanial therapy in the last 3 months,
  • no mucosal lesions,
  • no history of significant concomitant diseases including immunosuppression.

Exclusion criteria

Exclusion Criteria:

04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Intervention

    miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

    Drug: miltefosine plus intralesional pentamidine

Interventions

  • Drugmiltefosine plus intralesional pentamidine

    miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).

05

What researchers measure

Primary outcomes

  1. Lesion size

    area of lesion

    Time frame: 6 months post therapy

Secondary outcomes

  1. adverse effects at site

    pain, erythema, edema

    Time frame: days 1, 3, 5 of therapy

  2. systemic adverse effects

    gastrointestinal side effects

    Time frame: days 1 to 28 of therapy

06

Study locations

No study locations are listed for this record.

07

References and documents

Study documents

  • Study protocol · Oct 5, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03445897
Lead sponsor
Jonathan Berman
Responsible party
Jonathan Berman (President, AB Foundation) — Sponsor-investigator
First posted
Feb 26, 2018
Start date
Jan 31, 2016
Primary completion
Jan 31, 2018
Completion
Feb 21, 2018
Last update
Feb 27, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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