Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04825327
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2021-03-28
Brief Title:
Predicting the Future Incipient Tuberculosis
Sponsor:
Amsterdam Institute for Global Health and Development
Organization:
Amsterdam Institute for Global Health and Development
Study Overview
Official Title:
Predicting the Future Incipient Tuberculosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreFIT
Brief 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
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
Detailed Description:
Although the estimated numbers of people infected with TB in Africa are declining since the rollout of antiretroviral therapy a decade ago TB is still the highest in the world Early diagnosis and treatment of TB disease are essential to reducing morbidity and mortality Transformative progress will never be possible with the current diagnostic tools as they rely on the detection of active TB which usually happen after disease has already been spread to others Diagnostic technologies to accurately detect who will develop active TB are under development However their performance is not well reported
A better TB prediction test is needed to detect TB before clinical manifestation The PreFIT investigators hypothesize that volunteers with a combination of positive Xpert HR result high CRP andor low Hb levels will likely progress to active TB within 12 months They also hypothesize that those with TB will have early high Hepcidin Ferritin and Transferrin levels
The investigators plan to ask those found with TB at the local clinic if they accept to join the study The participants if they consent will then give information about people contacts who they stay with or meet frequently to also join the study Contacts who have TB symptoms will be asked to cough sputum to be tested for co-prevalent TB disease If they are found not to have TB disease they will be asked to give blood few drops from a finger prick and about 50mls from the vein on the arm to be stored and used for further tests Follow-up and sampling of enrolled contacts without co-prevalent active TB will occur at six and 12 months 21 days before or after each time point a six-week total window Participants meeting presumptive TB or sputum expectorator definitions at six M6 or 12 months M12 of follow-up or report with symptoms at any timepoint in-between will undergo Xpert Ultra or Xpert MTBRIF if Ultra unavailable and culture testing All positive cultures will undergo whole genome sequencing WGS to track index case and co-prevalent or incident case transmission Chest X-ray CXR will be done at M12 to potentially rule-out active disease missed by microbiological methods Passive TB diagnoses microbiological or empirical throughout the follow-up period will be captured
To prevent diagnostic information bias M0 and M6 test results for Xpert HR CRP and haemoglobin will be kept concealed to the study nurses and physicians who screen the cohort participants for active TB during follow-up Similarly laboratory technicians who test the stored samples for hepcidin transferrin and ferritin will be blinded to whether the sample is from a participant who developed active TB during follow-up or from a cohort participant who did not
The study will recruit 1515 trial participants each at Stellenbosch University in South Africa 1515 at Centro de Investigação em Saúde de Manhiça in Mozambique and 1010 at Makerere University in Uganda Participants will be between the ages of 12 and 60 years pregnant women minorities economic and education disadvantaged both HIV negative and positive will join the study Contacts found to have co-prevalent active TB potential pathologies on CXR abnormal Hb and CRP levels will be referred to the local clinic for investigation per standard-of-care with a written summary of the relevant study results All participant information will be treated in a strictly confidential manner and will be identified only by a code and not by any personal identifier
PreFITs results will contribute to the development and uptake of accurate cost-effective scalable and field-friendly diagnostic tools to facilitate scale-up of preventive treatment in sub-Saharan Africa and beyond
A better TB prediction test is needed to detect TB before clinical manifestation The PreFIT investigators hypothesize that volunteers with a combination of positive Xpert HR result high CRP andor low Hb levels will likely progress to active TB within 12 months They also hypothesize that those with TB will have early high Hepcidin Ferritin and Transferrin levels
The investigators plan to ask those found with TB at the local clinic if they accept to join the study The participants if they consent will then give information about people contacts who they stay with or meet frequently to also join the study Contacts who have TB symptoms will be asked to cough sputum to be tested for co-prevalent TB disease If they are found not to have TB disease they will be asked to give blood few drops from a finger prick and about 50mls from the vein on the arm to be stored and used for further tests Follow-up and sampling of enrolled contacts without co-prevalent active TB will occur at six and 12 months 21 days before or after each time point a six-week total window Participants meeting presumptive TB or sputum expectorator definitions at six M6 or 12 months M12 of follow-up or report with symptoms at any timepoint in-between will undergo Xpert Ultra or Xpert MTBRIF if Ultra unavailable and culture testing All positive cultures will undergo whole genome sequencing WGS to track index case and co-prevalent or incident case transmission Chest X-ray CXR will be done at M12 to potentially rule-out active disease missed by microbiological methods Passive TB diagnoses microbiological or empirical throughout the follow-up period will be captured
To prevent diagnostic information bias M0 and M6 test results for Xpert HR CRP and haemoglobin will be kept concealed to the study nurses and physicians who screen the cohort participants for active TB during follow-up Similarly laboratory technicians who test the stored samples for hepcidin transferrin and ferritin will be blinded to whether the sample is from a participant who developed active TB during follow-up or from a cohort participant who did not
The study will recruit 1515 trial participants each at Stellenbosch University in South Africa 1515 at Centro de Investigação em Saúde de Manhiça in Mozambique and 1010 at Makerere University in Uganda Participants will be between the ages of 12 and 60 years pregnant women minorities economic and education disadvantaged both HIV negative and positive will join the study Contacts found to have co-prevalent active TB potential pathologies on CXR abnormal Hb and CRP levels will be referred to the local clinic for investigation per standard-of-care with a written summary of the relevant study results All participant information will be treated in a strictly confidential manner and will be identified only by a code and not by any personal identifier
PreFITs results will contribute to the development and uptake of accurate cost-effective scalable and field-friendly diagnostic tools to facilitate scale-up of preventive treatment in sub-Saharan Africa and beyond
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None