NCT04825327Completed
Predicting the Future: Incipient Tuberculosis
Source: ClinicalTrials.gov · Last updated 5 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 3016 (actual)
- First submitted
- 28 Mar 2021
- Start date
- 21 Apr 2021
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Amsterdam Institute for Global Health and Development
- Diseases
- Tuberculosis
- NCT number
- NCT04825327
What you commit to
- Study type: Observational
- Participants enrolled: 3016
- From 21 Apr 2021 to the primary completion date, 31 Jan 2025
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has taken any form of TB treatment within the preceding two months (i.e., is currently on treatment). There are no exclusions based on any TB treatment more than two months prior.
Other
- Index cases
- No informed consent or assent
- More than six weeks has passed since the index case's first bacteriological result for TB was reported
- Patient was started on treatment based on empirical or clinical grounds (including CXR) alone
- Patient with rifampicin resistance (known from Xpert, Ultra, and/or MTBDRplus results)
- Contacts (cohort)
- No informed consent or assent
- Not diagnosed with active TB
- Unwilling or unable to provide blood
- More than six weeks has passed since reporting of the index case's first positive test result
Who the study is looking for
- Index cases
- ≥18 years old
- Willing to provide the contact information of people who meet the definition of contacts, or willing to refer those people (which make require the distribution of study pamphlets) so that may contact study staff
- Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment
- Willing to provide sputa (expectorated or induced) for culture; and
- Meeting the definition for active TB.
- Contacts (cohort)
- ≥12 years old
- Meeting contact definition
- Able and willing to return for follow-up visits, with no plans to move soon
- Willing to comply with study requirements i.e. provision of contact details and written, informed consent or assent prior to enrolment
- Willing and able to provide sputum and blood
- Agree to potentially undergo CXR at M12 (women
Age in the registry: 12 years to 60 years · Sex: All
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Invesigação em Saúde de Manhiça Coordinator of this site? Confirm its status | Manhiça | Mozambique | Unknown status |
| Makerere University Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
| University of Stellenbosch Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.