Utility of Xpert MTB/RIF Ultra and digital chest radiography for the diagnosis and treatment of TB in people living with HIV: a randomised controlled trial (XACT-TB).
HIV
TB
diagnosis
radiography
Journal
Transactions of the Royal Society of Tropical Medicine and Hygiene
ISSN: 1878-3503
Titre abrégé: Trans R Soc Trop Med Hyg
Pays: England
ID NLM: 7506129
Informations de publication
Date de publication:
03 01 2023
03 01 2023
Historique:
received:
15
03
2022
revised:
09
06
2022
accepted:
27
07
2022
pubmed:
14
8
2022
medline:
5
1
2023
entrez:
13
8
2022
Statut:
ppublish
Résumé
TB is a leading cause of morbidity among HIV positive individuals. Accurate algorithms are needed to achieve early TB diagnosis and treatment. We investigated the use of Xpert MTB/RIF Ultra in combination with chest radiography for TB diagnosis in ambulatory HIV positive individuals. This was a randomised controlled trial with a 2-by-2 factorial design. Outpatient HIV clinic attendees with cough were randomised to four arms: Arm 1-Standard Xpert/no chest radiography (CXR); Arm 2-Standard Xpert/CXR; Arm 3-Xpert Ultra/no CXR; and Arm 4-Xpert Ultra/CXR. Participants were followed up at days 28 and 56 to assess for TB treatment initiation. We randomised 640 participants. Bacteriologically confirmed TB treatment initiation at day 28 were: Arm 1 (8.4% [14/162]), Arm 2 (6.9% [11/159]), Arm 3 (8.2% [13/159]) and Arm 4 (5.6% [9/160]) and between Xpert Ultra group (Arms 3 and 4) (6.9% [22/319]) vs Standard Xpert group (Arms 1 and 2) (7.8% [25/321]), risk ratio 0.89 (95% CI 0.51 to 1.54). By day 56, there were also similar all-TB treatment initiations in the x-ray group (Arms 2 and 4) (16.0% [51/319]) compared with the no x-ray group (Arms 1 and 3) (13.1% [42/321]), risk ratio 1.22 (95% CI 0.84 to 1.78); however, the contribution of clinically diagnosed treatment initiations were higher in x-ray groups (50.9% vs 19.0%). Xpert Ultra performed similarly to Xpert MTB/RIF. X-rays are useful for TB screening but further research should investigate how to mitigate false-positive treatment initiations.
Sections du résumé
BACKGROUND
TB is a leading cause of morbidity among HIV positive individuals. Accurate algorithms are needed to achieve early TB diagnosis and treatment. We investigated the use of Xpert MTB/RIF Ultra in combination with chest radiography for TB diagnosis in ambulatory HIV positive individuals.
METHODS
This was a randomised controlled trial with a 2-by-2 factorial design. Outpatient HIV clinic attendees with cough were randomised to four arms: Arm 1-Standard Xpert/no chest radiography (CXR); Arm 2-Standard Xpert/CXR; Arm 3-Xpert Ultra/no CXR; and Arm 4-Xpert Ultra/CXR. Participants were followed up at days 28 and 56 to assess for TB treatment initiation.
RESULTS
We randomised 640 participants. Bacteriologically confirmed TB treatment initiation at day 28 were: Arm 1 (8.4% [14/162]), Arm 2 (6.9% [11/159]), Arm 3 (8.2% [13/159]) and Arm 4 (5.6% [9/160]) and between Xpert Ultra group (Arms 3 and 4) (6.9% [22/319]) vs Standard Xpert group (Arms 1 and 2) (7.8% [25/321]), risk ratio 0.89 (95% CI 0.51 to 1.54). By day 56, there were also similar all-TB treatment initiations in the x-ray group (Arms 2 and 4) (16.0% [51/319]) compared with the no x-ray group (Arms 1 and 3) (13.1% [42/321]), risk ratio 1.22 (95% CI 0.84 to 1.78); however, the contribution of clinically diagnosed treatment initiations were higher in x-ray groups (50.9% vs 19.0%).
CONCLUSIONS
Xpert Ultra performed similarly to Xpert MTB/RIF. X-rays are useful for TB screening but further research should investigate how to mitigate false-positive treatment initiations.
Identifiants
pubmed: 35963826
pii: 6665964
doi: 10.1093/trstmh/trac079
pmc: PMC9808509
doi:
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
28-37Subventions
Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 200901/Z/16/Z
Pays : United Kingdom
Organisme : Wellcome
ID : WT200901
Organisme : Wellcome Trust
ID : 206575/Z/17/Z
Pays : United Kingdom
Informations de copyright
© The Author(s) 2022. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.
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