Status:
TERMINATED
Eumycetoma Long-term Post-Treatment Follow-Up Study
Lead Sponsor:
Drugs for Neglected Diseases
Collaborating Sponsors:
Soba University Hospital
Conditions:
Eumycetoma
Eligibility:
All Genders
15+ years
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 p...
Eligibility Criteria
Inclusion
- Clinical trial participants who were previously enrolled and received investigational product (fosravuconazole) or standard of care treatment (itraconazole) in the DNDi-FOSR-04-MYC clinical trial.
- In trial DNDi-FOSR-04-MYC had no recurrence of eumycetoma lesion before month 15.
- Able and willing to give written informed consent for participation in this study, prior to performance of any study procedures.
Exclusion
- 1\. Any condition that, in the opinion of the Principal Investigator or designee, would preclude provision of informed consent or interfere with achieving the study objectives.
Key Trial Info
Start Date :
January 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2023
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06514183
Start Date
January 26 2023
End Date
June 26 2023
Last Update
July 23 2024
Active Locations (1)
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1
Mycetoma Research Center, Soba University Hospital
Khartoum, Sudan