Addressing the challenges associated with neglected infectious diseases in at-risk individuals

Not Applicable

• Conditions: Pulmonary fungal co-infections in patients with TB-like symptoms; Infections and Infestations

• Registration Number: ISRCTN33572982
• Lead Sponsor: European & Developing Countries Clinical Trials Partnership

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37581914/ (added 16/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-17
• Last Update Posted: 9 October 2023
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. HIV/AIDS patients suspected of TB
2. Presenting with TB-like symptoms including a chronic cough that has persisted for more than 3 months
3. Aged 18 years and above
4. TB naive
5. Give consent

Exclusion Criteria

1. Critically ill patients, who would delay recruitment due to associated delays in sample collection and consent
2. Diabetics and pregnant women suspected of TB are managed differently according to TB guidelines
3. HIV/AIDs patients with TB-like symptoms but on anti-TB treatment
4. Patients with a known diagnosis

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pulmonary fungal infections measured using Prevalence Index at baseline and 18, 30 and 36 months

Secondary Outcome Measures

Name	Time	Method
Clinical management measured using a diagnostic approach at baseline and 36 months