Eumycetoma Long-term Post-Treatment Follow-Up Study

NCT06514183 | Terminated

• 1 other identifier: DNDi-FOSR-05-MYC
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eumycetoma

Keywords

Mycetoma; Madura foot; Madurella mycetomatis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  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

  6 years

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

  15 months

Interventions

Clinical diagnosis of recurrence OTHER

Clinical diagnosis of recurrence

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead
• Soba University Hospital: collaborator

Study Sites (1)

Mycetoma Research Center, Soba University Hospital

Khartoum, Sudan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy of masses on the infected sites and serum samples

MeSH Terms

Conditions

Mycetoma

Condition Hierarchy (Ancestors)

Nocardia Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Dermatomycoses; Mycoses; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Borna A Nyaoke, M.D

  Drugs for Neglected Diseases initiative

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: July 23, 2024
• Study Start: January 26, 2023
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Currently available with no end date
• Access Criteria: Must adhere to appropriate agreement or terms of use and contractual obligations which DNDi may have with its partners.

Locations

SU (1)