An observational study in Eumycetoma, sponsored by Drugs for Neglected Diseases. Terminated at 1 site in Sudan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Drugs for Neglected Diseases · Observational
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.
Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinical diagnosis of recurrence
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
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
Plan to share: Yes — Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
Data sharing details ↗ · dndi.org
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Jun 2023, 5 months.
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This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Mycetoma
Drugs for Neglected Diseases