Mycetoma Retrospective Data Collection

Recruiting

• Conditions: Mycetoma

• Registration Number: NCT06512714
• Lead Sponsor: Drugs for Neglected Diseases

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.

Study Timeline

• Study Start: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of mycetoma disease as evidenced by patient diagnosis	Over 10 years	Sources: Medical records and/or laboratory records and/or radiologic records.

Secondary Outcome Measures

Name	Time	Method
Presence of mycetoma disease after treatment or surgery	Over 10 years	Sources: Medical records and laboratory records
Lesion size in centimeters	Over 10 years	Sources: Medical records and laboratory records

Trial Locations

Locations (2)

Postgraduate Institute of Medical Education and Research; 🇮🇳 Chandigarh, India

Universite Cheikh Anta Diop de Dakar; 🇸🇳 Dakar, Senegal