Eumycetoma Long-term Post-Treatment Follow-Up Study

Drugs for Neglected Diseases

Status: Terminated

Conditions: Eumycetoma

Treatments: Other: Clinical diagnosis of recurrence

Study type: Observational

Funder types: Other

Identifiers

NCT06514183

DNDi-FOSR-05-MYC

Details and patient eligibility

About

To assess the long-term recurrence rate of eumycetoma in clinical trial participants treated in the phase II DNDi-FOSR-04-MYC clinical trial.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. In trial DNDi-FOSR-04-MYC had no recurrence of eumycetoma lesion before month 15.
3. Able and willing to give written informed consent for participation in this study, prior to performance of any study procedures.

Exclusion criteria

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.