Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512714
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Mycetoma Retrospective Data Collection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Estimating the Burden of Mycetoma A Retrospective Analysis of Hospital Records
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period The main objectives are to
Determine the number of mycetoma cases diagnosed per year and trends over time
Describe characteristics of diagnosed mycetoma cases
1 Describe demographic characteristics of patients with mycetoma
2 Describe clinical characteristics of patients with mycetoma upon initial presentation and over time
Assess etiology of mycetoma cases
Characterize clinical management of mycetoma cases
1 Characterize approaches to diagnosis of mycetoma
2 Investigate types and durations of treatments including medical and surgical approaches utilized to treat mycetoma cases
3 Describe clinical outcomes among patients with mycetoma
The study team will review all available medical laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data
Determine the number of mycetoma cases diagnosed per year and trends over time
Describe characteristics of diagnosed mycetoma cases
1 Describe demographic characteristics of patients with mycetoma
2 Describe clinical characteristics of patients with mycetoma upon initial presentation and over time
Assess etiology of mycetoma cases
Characterize clinical management of mycetoma cases
1 Characterize approaches to diagnosis of mycetoma
2 Investigate types and durations of treatments including medical and surgical approaches utilized to treat mycetoma cases
3 Describe clinical outcomes among patients with mycetoma
The study team will review all available medical laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data
Detailed Description:
Mycetoma is a poorly understood neglected tropical disease which disproportionately affects the poorest of the poor and is associated with substantial morbidity The disease presents a multitude of diagnostic and management challenges in particular effective treatments for eumycetoma the fungal and least understood form of the disease are lacking DNDi and partners aim to conduct late-phase clinical trials on a promising new pharmacologic treatment for eumycetoma but substantial knowledge gaps preclude such trials These knowledge gaps include data on the burden distribution causative agents clinical presentation natural history and common approaches to diagnosis and treatment of mycetoma in endemic countries
This study a retrospective review of mycetoma cases aims to generate such data from several countries suggested by preliminary data to potentially be good candidate clinical trial sites
This study a retrospective review of mycetoma cases aims to generate such data from several countries suggested by preliminary data to potentially be good candidate clinical trial sites
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