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Predicting the Future: Incipient Tuberculosis

NCT04825327 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3016

Last updated 2025-02-05

No results posted yet for this study

Summary

The investigators will study, prospectively, if contacts (household or close contacts) of tuberculosis (TB) patients with high C-reactive protein (CRP), low hemoglobin (Hb) levels, and a positive Xpert Host Response (HR) cartridge result develop active TB within 12 months. They will also investigate if there is a correlation between progressing to active TB within 12 months and having high levels of the iron homeostasis markers (Hepcidin, Ferritin and Transferrin).

Identified index cases who agree to participate will refer their household or close contacts to also join the study. These contacts will be tested for TB and only contacts who are negative will be enrolled and followed-up at 6 months and 12 months. Blood samples will be collected at baseline and 6 months for testing. During the study period, TB testing will be done on contacts who meet symptoms criteria. At 12 months, all contacts will undergo a chest x-ray to assist in the diagnosis of TB.

PreFIT will target people aged 12 to 60 years of age and both HIV negative and positive. 1515 trial participants will be recruited at Stellenbosch University in South Africa, 1515 at Fundaçao Manhiça in Mozambique and 1010 at Makerere University in Uganda, respectively.

Conditions

Sponsors & Collaborators

  • University of Stellenbosch

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • Centro de Investigacao em Saude de Manhica

    collaborator OTHER

  • Barcelona Institute for Global Health

    collaborator OTHER

  • Foundation for Innovative New Diagnostics, Switzerland

    collaborator OTHER

  • Amsterdam Institute for Global Health and Development

    lead OTHER

Principal Investigators

  • Grant Theron, PhD · University of Stellenbosch

  • Alberto L Garcia-Basteiro, PhD · Barcelona Institute for Global Health

  • Adam Penn-Nicholson, PhD · The Foundation for Innovative New Diagnostics

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Mozambique
  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04825327 on ClinicalTrials.gov