TerminatedNot Applicable

Eumycetoma Long-term Post-Treatment Follow-Up Study

Stopped: Due to the socio-political sutuation in Sudan affecting patient follow-up

Sudan51 participantsStarted 2023-01-26

Plain-language 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.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

To assess recurrence of eumycetoma lesions up to 5 years after end of treatment in participants previously treated with fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC

Timeframe: 6 years

Trial details

NCT IDNCT06514183

SponsorDrugs for Neglected Diseases

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-26

View on ClinicalTrials.gov More Eumycetoma trials