Eumycetoma Long-term Post-Treatment Follow-Up Study

Drugs for Neglected Diseases51 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Eumycetoma

Interventions

Clinical diagnosis of recurrenceOTHER

Clinical diagnosis of recurrence

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mycetoma Research Center, Soba University Hospital

Khartoum, Sudan

Outcomes

Primary Outcomes

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

Population: Participants in trial DNDi-FOSR-04-MYC who had no recurrence of eumycetoma lesion before month 15 * Treatment: fosravuconazole 200 mg or 300 mg weekly or itraconazole 400 mg daily in study DNDi-FOSR-04-MYC * Variable: Time to recurrence of eumycetoma lesion (if lesion occurred) or time followed-up without lesion

Time frame: 6 years

Secondary Outcomes

To determine efficacy of fosravuconazole 200 mg or 300 mg monotherapy vs. itraconazole monotherapy, after long term post-treatment follow-up

Population/Treatment/Variable/Intercurrent events: as for primary estimand Hazard ratios comparing a) risk of recurrence for fosravuconazole 200mg vs. itraconazole

Time frame: 15 months

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

Population: Participants in trial DNDi-FOSR-04-MYC regardless of recurrence before Month 15. Treatment/Variable/Intercurrent events: as defined for the primary estimand

Time frame: 6 years

To describe the etiologic pathogen (subtype of fungus) after long term recurrence

Population: Participants with recurrence of eumycetoma within the current study Summary measure: Proportion of recurrences of each subtype * Treatment: as for primary estimand * Variable: Typing of fungus

Time frame: 15 months

Data from ClinicalTrials.gov

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