Mycetoma Retrospective Data Collection

ClinicalTrials.gov ID

NCT06512714

Lead Sponsor

Drugs for Neglected DiseasesOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

1,600Estimated

Last Update Posted

Aug 1, 2024Actual

Start Date

Jun 20, 2024Actual

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Aug 31, 2024Estimated

Official Title

Estimating the Burden of Mycetoma: A Retrospective Analysis of Hospital Records

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.

• Mycetoma

• A diagnosis of mycetoma in a medical, radiologic, or laboratory record.

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Case-Only

Time Perspective

Retrospective

Lead Sponsor

Drugs for Neglected DiseasesOTHER

Collaborators

Cheikh Anta Diop University, SenegalOTHER

Post Graduate Institute of Medical Education and Research, ChandigarhOTHER

doudou.sow@ugb.edu.sn+221775425028

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