Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cheikh Anta Diop University, Senegal | OTHER |
| Post Graduate Institute of Medical Education and Research, Chandigarh | OTHER |
Not provided
Not provided
Not provided
Not provided
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:
Determine the number of mycetoma cases diagnosed per year and trends over time.
Describe characteristics of diagnosed mycetoma cases.
Assess etiology of 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A diagnosis of mycetoma in a medical, radiologic, or laboratory record. | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of mycetoma disease as evidenced by patient diagnosis | Sources: Medical records and/or laboratory records and/or radiologic records. | Over 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion size in centimeters | Sources: Medical records and laboratory records | Over 10 years |
| Presence of mycetoma disease after treatment or surgery | Sources: Medical records and laboratory records |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Borna A Nyaoke, M.D | Contact | +254 203995031 | bnyaoke@dndi.org | |
| Thaddaeus W Egondi, Dr. | Contact | tegondi@dndi.org |
| Name | Affiliation | Role |
|---|---|---|
| Doudou Sow, PhD | Université Gaston Berger | Principal Investigator |
| Shivaprakash M Rudramurthy, M.D | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Postgraduate Institute of Medical Education and Research | Not yet recruiting | Chandigarh | 160012 | India |
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
Within 24 months of last subject last visit
Data Requestors seeking individual participant level data will enter into an appropriate agreement or terms of use.
Not provided
| ID | Term |
|---|---|
| D008271 | Mycetoma |
| ID | Term |
|---|---|
| D009617 | Nocardia Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
| Over 10 years |
| Universite Cheikh Anta Diop de Dakar | Recruiting | Dakar | Senegal |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |