Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550609
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment of Bolivian L Braziliensis Mucosal Leishmaniasis With Inhaled Pentamidine Plus Oral Miltefosine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2 study of the combination of inhaled-pentamidine plus oral miltefosine for Bolivian mucosal leishmaniasis
Detailed Description:
The 3 major forms of leishmaniasis are visceral cutaneous and mucosal disease Of these mucosal leishmaniasis ML arguably poses the most difficult therapeutic problem Although visceral disease VL occurs in perhaps 300000 persons a year Alvar 2012 and is rapidly fatal since TH1 immunity is lacking visceral disease is well-treated by drugs Whereras cutaneous disease CL is the most prevalent major form occurring in perhaps 1000000 persons a year Alvar 2012 TH1 Immunity is present and CL self-resolves in 3-18 months CL is treated to speed healing of the cutaneous lesion and for certain species to try to prevent dissemination of parasites to the oro-nasal mucosa resulting in mucosal leishmaniasis
Mucosal leishmaniasis ML is estimated to occur as a late sequella in approximately 3 of L braziliensis CL Cincura 2017 If there are approximately 130000 cases per year of L braziliensis cutaneous disease Alvar 2012 and 3 of these are succeeded by ML the approximately 4000 yearly cases of L braziliensis ML makes ML far less common than VL or CL However and in spite of more TH1 immunity than cutaneous disease Carvalho 1985 self-cure of ML is so rare as to be reportable Marsden 1991 The patient with ML experiences inexorable erosion of the cartilage of the nose pharynx palate and larynx ML has been difficult to treat with classical agents a cure rate of approximately 71 see section 12 Thus of the 3 common forms of leishmaniasis ML is the form that combines disease severity with poor response to chemotherapy
Mucosal leishmaniasis ML is estimated to occur as a late sequella in approximately 3 of L braziliensis CL Cincura 2017 If there are approximately 130000 cases per year of L braziliensis cutaneous disease Alvar 2012 and 3 of these are succeeded by ML the approximately 4000 yearly cases of L braziliensis ML makes ML far less common than VL or CL However and in spite of more TH1 immunity than cutaneous disease Carvalho 1985 self-cure of ML is so rare as to be reportable Marsden 1991 The patient with ML experiences inexorable erosion of the cartilage of the nose pharynx palate and larynx ML has been difficult to treat with classical agents a cure rate of approximately 71 see section 12 Thus of the 3 common forms of leishmaniasis ML is the form that combines disease severity with poor response to chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None