Mycetoma Retrospective Data Collection

NCT06512714 | Recruiting

• 1 other identifier: DNDi-OBS-03-MYC
• Study Type: observational
• Target: 1,600
• Locations: 2 countries
• Sites: 2

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.
• Describe demographic characteristics of patients with mycetoma.
• Describe clinical characteristics of patients with mycetoma upon initial presentation and over time.
• Assess etiology of mycetoma cases.
• Characterize clinical management of mycetoma cases.
• Characterize approaches to diagnosis of mycetoma.
• Investigate types and durations of treatments (including medical and surgical approaches) utilized to treat mycetoma cases.
• Describe clinical outcomes among patients with mycetoma.

Conditions

Mycetoma

Outcome Measures

Primary Outcomes (1)

• Presence of mycetoma disease as evidenced by patient diagnosis

  Sources: Medical records and/or laboratory records and/or radiologic records.

  Over 10 years

Secondary Outcomes (2)

• Lesion size in centimeters

  Over 10 years

• Presence of mycetoma disease after treatment or surgery

  Over 10 years

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with illegible or inaccessible health records.

Sponsors & Collaborators

• Drugs for Neglected Diseases: lead
• Cheikh Anta Diop University, Senegal: collaborator
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Study Sites (2)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

NOT YET RECRUITING

Universite Cheikh Anta Diop de Dakar

Dakar, Senegal

RECRUITING

MeSH Terms

Conditions

Mycetoma

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Nocardia Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Bacterial; Dermatomycoses; Mycoses; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Doudou Sow, PhD

  Université Gaston Berger

  PRINCIPAL INVESTIGATOR

• Shivaprakash M Rudramurthy, M.D

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Borna A Nyaoke, M.D

CONTACT

+254 203995031; bnyaoke@dndi.org

Thaddaeus W Egondi, Dr.

CONTACT

tegondi@dndi.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: June 20, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 24 months of last subject last visit
• Access Criteria: Data Requestors seeking individual participant level data will enter into an appropriate agreement or terms of use.

Locations

SE (1); IN (1)