Miltefosine Plus IL Pentamidine for Bolivian CL | NCT03445897

Studies
Miltefosine Plus IL Pentamidine for Bolivian CL

NCT03445897

Sponsor

Jonathan Berman

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

50Actual

Phase

Phase 2

Conditions

Leishmaniasis, Cutaneous

Interventions

miltefosine plus intralesional pentamidine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2016Actual

Primary Completion Date

Jan 31, 2018Actual

Completion Date

Feb 21, 2018Actual

First Submitted Date

Feb 21, 2018

First Submission Date that Met QC Criteria

Feb 21, 2018

First Posted Date

Feb 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2018

Last Update Posted Date

Feb 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
miltefosine plus intralesional pentamidine	Drug	miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lesion size	area of lesion	6 months post therapy

Secondary Outcomes

Measure	Description	Time Frame
adverse effects at site	pain, erythema, edema	days 1, 3, 5 of therapy
systemic adverse effects	gastrointestinal side effects	days 1 to 28 of therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 5, 2015	Feb 21, 2018	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D016773	Leishmaniasis, Cutaneous

Ancestor Terms

ID	Term
D007896	Leishmaniasis
D056986	Euglenozoa Infections
D011528	Protozoan Infections
D010272	Parasitic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C039128	miltefosine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description