Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514183
Status:
TERMINATED
Last Update Posted:
None
First Post:
2023-03-22
Brief Title:
Eumycetoma Long-term Post-Treatment Follow-Up Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Long Term Post-treatment Follow-up After End of Study 15 Months of Clinical Trial Participants Enrolled in DNDi-FOSR-04-MYC
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the socio-political sutuation in Sudan affecting patient follow-up
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the long-term recurrence rate of eumycetoma in clinical trial participants treated in the phase II DNDi-FOSR-04-MYC clinical trial
Detailed Description:
The purpose of the long-term post treatment follow-up study is to collect data on recurrence of eumycetoma lesions in participants who previously participated in A randomized double blind phase II proof-of-concept superiority trial of fosravuconazole 200 mg or 300 mg weekly dose versus itraconazole 400 mg daily all three arms in combination with surgery in participants with eumycetoma in Sudan DNDi-FOSR-04-MYC
These data will provide additional information on recurrences after end of study 15 months of the parent clinical trial DNDi-FOSR-04-MYC The study is observational since there is no intervention in this protocol but assesses the outcome of the intervention of the parent trial
These data will provide additional information on recurrences after end of study 15 months of the parent clinical trial DNDi-FOSR-04-MYC The study is observational since there is no intervention in this protocol but assesses the outcome of the intervention of the parent trial
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