An observational study in Mycetoma, sponsored by Drugs for Neglected Diseases. Recruiting at 2 sites in 2 countries. Per ClinicalTrials.gov, last updated 2024-08-01.
Sponsored by Drugs for Neglected Diseases · Observational
The goal of this retrospective observational study is to describe mycetoma cases detected in health care facilities in India and Senegal in a 10-year period. The main objectives are to:
Describe characteristics of diagnosed mycetoma cases.
Characterize clinical management of mycetoma cases.
The study team will review all available medical, laboratory and radiologic records of identified mycetoma cases and use data collection forms to extract relevant data.
Mycetoma is a poorly understood neglected tropical disease which disproportionately affects the poorest of the poor and is associated with substantial morbidity. The disease presents a multitude of diagnostic and management challenges; in particular, effective treatments for eumycetoma, the fungal and least understood form of the disease are lacking. DNDi and partners aim to conduct late-phase clinical trials on a promising new pharmacologic treatment for eumycetoma, but substantial knowledge gaps preclude such trials. These knowledge gaps include data on the burden, distribution, causative agents, clinical presentation, natural history, and common approaches to diagnosis and treatment of mycetoma in endemic countries.
This study, a retrospective review of mycetoma cases, aims to generate such data from several countries suggested by preliminary data to potentially be good candidate clinical trial sites.
Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For each patient, data will be extracted for each clinical, laboratory or radiologic visit related to the condition that may meet this study's case definition.
Presence of mycetoma disease as evidenced by patient diagnosis
Sources: Medical records and/or laboratory records and/or radiologic records.
Time frame: Over 10 years
Lesion size in centimeters
Sources: Medical records and laboratory records
Time frame: Over 10 years
Presence of mycetoma disease after treatment or surgery
Sources: Medical records and laboratory records
Time frame: Over 10 years
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, de-identified or aggregated data will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Within 24 months of last subject last visit
Access criteria: Data Requestors seeking individual participant level data will enter into an appropriate agreement or terms of use.
Data sharing details ↗ · dndi.org
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Aug 2024, 2 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mycetoma
Drugs for Neglected Diseases