Eumycetoma Long-term Post-Treatment Follow-Up Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-26

Study Completion Date

2023-06-26

Brief Summary

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

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Detailed Description

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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

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Eumycetoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Clinical diagnosis of recurrence

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No