Clinical trial NCT06512714: Mycetoma Retrospective Data Collection
Official title: Estimating the Burden of Mycetoma: A Retrospective Analysis of Hospital Records
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mycetoma
Lead sponsor: Drugs for Neglected Diseases
Sponsor class: OTHER
Collaborators: name: Cheikh Anta Diop University, Senegal
name: Post Graduate Institute of Medical Education and Research, Chandigarh
First posted: 2024-07-22
Enrollment: 1600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.

Brief summary: 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.

  1. Describe demographic characteristics of patients with mycetoma.
  2. Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.
* Assess etiology of mycetoma cases.
* Characterize clinical management of mycetoma cases.

  1. Characterize approaches to diagnosis of mycetoma.
  2. Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.
  3. Describe clinical outcomes among patients with mycetoma.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Any patient given a diagnosis of mycetoma in a medical, radiologic, or laboratory record.

Exclusion Criteria:

* Patients with illegible or inaccessible health records.

Primary outcomes:
measure: Presence of mycetoma disease as evidenced by patient diagnosis
timeFrame: Over 10 years
Secondary outcomes:
measure: Lesion size in centimeters
timeFrame: Over 10 years
measure: Presence of mycetoma disease after treatment or surgery
timeFrame: Over 10 years
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
city: Dakar
country: Senegal
facility: Universite Cheikh Anta Diop de Dakar
Study officials:
affiliation: Université Gaston Berger
name: Doudou Sow, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Shivaprakash M Rudramurthy, M.D
role: PRINCIPAL_INVESTIGATOR
References: