Mycetoma Retrospective Data Collection

NCT ID: NCT06512714

Last Updated: 2024-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-08-31

Brief Summary

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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

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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.

Conditions

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Mycetoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cheikh Anta Diop University, Senegal

OTHER

Sponsor Role collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role collaborator

Drugs for Neglected Diseases

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doudou Sow, PhD

Role: PRINCIPAL_INVESTIGATOR

Université Gaston Berger

Shivaprakash M Rudramurthy, M.D

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

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Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Site Status NOT_YET_RECRUITING

Universite Cheikh Anta Diop de Dakar

Dakar, , Senegal

Site Status RECRUITING

Countries

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India Senegal

Central Contacts

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Borna A Nyaoke, M.D

Role: CONTACT

+254 203995031

Thaddaeus W Egondi, Dr.

Role: CONTACT

Facility Contacts

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Shivaprakash M Rudramurthy, M.D

Role: primary

+9316175146

Doudou Sow, PhD

Role: primary

+221775425028

Babacar T Faye

Role: backup

Other Identifiers

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DNDi-OBS-03-MYC

Identifier Type: -

Identifier Source: org_study_id

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