EumycetomaNCT06514183
Eumycetoma Long-term Post-Treatment Follow-Up Study
An observational study of Eumycetoma, run by Drugs for Neglected Diseases at 1 site in Sudan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Eumycetoma
- What is being tested?
- Clinical diagnosis of recurrence
- How many people
- 51 participants
- Where
- 1 siteSudan
- Study dates
- 26 Jan 2023to 26 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Eumycetoma
- Being tested
- Clinical diagnosis of recurrence
- Keywords
- Mycetoma, Madura foot, Madurella mycetomatis
- Medical subject headings
- Mycetoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical diagnosis of recurrenceOther
Clinical diagnosis of recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Population/Treatment/Variable/Intercurrent events: as for primary estimand Hazard ratios comparing a) risk of recurrence for fosravuconazole 200mg vs. itraconazole
Measured: 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
Measured: 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
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start26 Jan 2023
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Why it stopped: Due to the socio-political sutuation in Sudan affecting patient follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EumycetomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Soba University Hospital
- Responsible party
- Sponsor
- Investigators
- Borna A Nyaoke, M.D, Study director, Drugs for Neglected Diseases initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514183
- Sponsor's protocol ID
- DNDi-FOSR-05-MYC
- Status last verified
- Jul 2024
- First submitted
- 22 Mar 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Post-treatment Follow-up After End of Study (>15 Months) of Clinical Trial Participants Enrolled in DNDi-FOSR-04-MYC
- ClinicalTrials.gov ID
- NCT06514183
- Acronym / sponsor ID
- DNDi-FOSR-05-MYC
- Conditions
- Eumycetoma
- Keywords
- Mycetoma, Madura foot, Madurella mycetomatis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the socio-political sutuation in Sudan affecting patient follow-up
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Soba University Hospital
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the long-term recurrence rate of eumycetoma in clinical trial participants treated in the phase II DNDi-FOSR-04-MYC clinical trial.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical diagnosis of recurrenceClinical diagnosis of recurrence | Other | – |
Primary outcome
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
Time frame: 6 years
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
3 secondary outcomes
To determine efficacy of fosravuconazole 200 mg or 300 mg monotherapy vs. itraconazole monotherapy, after long term post-treatment follow-up
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
Time frame: 6 years
To describe the etiologic pathogen (subtype of fungus) after long term recurrence
Time frame: 15 months
Results and safety
The study was stopped early (reason given: Due to the socio-political sutuation in Sudan affecting patient follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. Through Drugs for Neglected Diseases Initiative (DNDi) and open data sharing platforms. The data may be obtained by sending a request to DNDi
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Borna A Nyaoke, M.D study director
Drugs for Neglected Diseases initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eumycetoma, run by Drugs for Neglected Diseases at 1 site in Sudan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sudan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to the socio-political sutuation in Sudan affecting patient follow-up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.