Eumycetoma Long-term Post-Treatment Follow-Up Study

Long Term Post-treatment Follow-up After End of Study (>15 Months) of Clinical Trial Participants Enrolled in DNDi-FOSR-04-MYC

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

Study Overview

• Status: Terminated
• Conditions: Eumycetoma
• Intervention / Treatment: Other: Clinical diagnosis of recurrence

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 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 (Actual): 51

Contacts and Locations

Study Locations

• Sudan
  • Khartoum, Sudan
    • Mycetoma Research Center, Soba University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of the clinical trial participants that were recruited in the RCT trial DNDi-FOSR-04-MYC. The RCT had enrolled 104 clinical trial participants with 29 having recurrence before month 15. Therefore, the long-term post-treatment follow-up assessment will target 75 participants that had no recurrence indicated at end of study or who had not completed the study i.e., those who had been regarded as lost to follow up but may now be available.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	15 months

Collaborators and Investigators

• Sponsor: Drugs for Neglected Diseases
• Collaborators: Soba University Hospital
• Investigators: Study Director: Borna A Nyaoke, M.D, Drugs for Neglected Diseases initiative

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Mycetoma; Madura foot; Madurella mycetomatis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Skin Diseases, Infectious; Mycoses; Skin Diseases, Bacterial; Dermatomycoses; Nocardia Infections; Mycetoma
• Other Study ID Numbers: DNDi-FOSR-05-MYC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi
• IPD Sharing Time Frame: Currently available with no end date
• IPD Sharing Access Criteria: Must adhere to appropriate agreement or terms of use and contractual obligations which DNDi may have with its partners.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No