NCT06514183

Eumycetoma Long-term Post-Treatment Follow-Up Study

Long Term Post-treatment Follow-up After End of Study (>15 Months) of Clinical Trial Participants Enrolled in DNDi-FOSR-04-MYC

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 51 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eumycetoma

Interventions

Type	Name	Description
OTHER	Clinical diagnosis of recurrence	Clinical diagnosis of recurrence

Timeline

• Start date: 2023-01-26
• Primary completion: 2023-06-26
• Completion: 2023-06-26
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: Sudan