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BMC Infect Dis. 2017 Jun 16;17(1):433. doi: 10.1186/s12879-017-2534-2.

Treatment decisions and mortality in HIV-positive presumptive smear-negative TB in the Xpert™ MTB/RIF era: a cohort study.

Author information

1
Infectious Diseases Institute, Makerere University College of Health Sciences, P.O. Box 22418, Kampala, Uganda. s.hermans@aighd.org.
2
Department of Internal Medicine, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda. s.hermans@aighd.org.
3
Department of Global Health, Academic Medical Center, University of Amsterdam, Amsterdam Institute for Global Health and Development, Amsterdam, The Netherlands. s.hermans@aighd.org.
4
Infectious Diseases Institute, Makerere University College of Health Sciences, P.O. Box 22418, Kampala, Uganda.
5
Institute for Tropical Medicine, University of Antwerp, Antwerp, Belgium.
6
Global Health Institute, University of Antwerp, Antwerp, Belgium.
7
Institute of Public Health, University of Cambridge, Cambridge, UK.
8
Department of Internal Medicine, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.
9
Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, USA.

Abstract

BACKGROUND:

The Xpert™ MTB/RIF (XP) has a higher sensitivity than sputum smear microscopy (70% versus 35%) for TB diagnosis and has been endorsed by the WHO for TB high burden countries to increase case finding among HIV co-infected presumptive TB patients. Its impact on the diagnosis of smear-negative TB in a routine care setting is unclear. We determined the change in diagnosis, treatment and mortality of smear-negative presumptive TB with routine use of Xpert MTB/RIF (XP).

METHODS:

Prospective cohort study of HIV-positive smear-negative presumptive TB patients during a 12-month period after XP implementation in a well-staffed and trained integrated TB/HIV clinic in Kampala, Uganda. Prior to testing clinicians were asked to decide whether they would treat empirically prior to Xpert result; actual treatment was decided upon receipt of the XP result. We compared empirical and XP-informed treatment decisions and all-cause mortality in the first year.

RESULTS:

Of 411 smear-negative presumptive TB patients, 175 (43%) received an XP; their baseline characteristics did not differ. XP positivity was similar in patients with a pre-XP empirical diagnosis and those without (9/29 [17%] versus 14/142 [10%], P = 0.23). Despite XP testing high levels of empirical treatment prevailed (18%), although XP results did change who ultimately was treated for TB. When adjusted for CD4 count, empirical treatment was not associated with higher mortality compared to no or microbiologically confirmed treatment.

CONCLUSIONS:

XP usage was lower than expected. The lower sensitivity of XP in smear-negative HIV-positive patients led experienced clinicians to use XP as a "rule-in" rather than "rule-out" test, with the majority of patients still treated empirically.

KEYWORDS:

Empirical treatment; HIV Infections/complications; Molecular diagnostic techniques/methods; Tuberculosis, pulmonary/diagnosis; Tuberculosis, pulmonary/epidemiology

PMID:
28622763
PMCID:
PMC5473987
DOI:
10.1186/s12879-017-2534-2
[Indexed for MEDLINE]
Free PMC Article

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