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RESEARCH: Lessons from the largest diagnostic trial on TB occurring outside the lungs

Nov. 9, 2022
RESEARCH: Lessons from the largest diagnostic trial on TB occurring outside the lungs
A snip from the Clinical Infectious Diseases journal with insets of Ifakara Health Institute researchers, Dr. Robert Ndege and Dr. Martin Rohacek, who contributed immensely to the study and the publication. GRAPHIC | KMC/2022.

Ifakara researchers along with colleagues from the Swiss TPH and the University of Basel have shared results from a study in which they investigated ultrasound tests in the management of tuberculosis which occurs outside the lungs - technically known as “extrapulmonary tuberculosis”.

The study, which was conducted between 2018 and 2020, aimed to assess the impact of extended Focused Assessment with Sonography for HIV and Tuberculosis (eFASH) – a tool to detect signs of extrapulmonary TB – on the correct management of persons with suspected extrapulmonary TB. The eFASH trial is one of the largest diagnostic trials done so far on TB occurring outside the lungs.

According to the study results, the eFASH did not increase the proportion of correctly managed patients with suspected extrapulmonary TB versus control, however, it did increase the proportion of definite TB by uncomplicated invasive tests.

Ifakara researchers who contributed to the study included: Robert Ndege, Omary Ngome, Farida Bani, Yvan Temba, Herieth Wilson, Jerry Hella, Mohamed Sasamalo, Dorcas Mnzava, Namvua Kimera, Hellen Hiza, John Wigayi, Herry Mapesi, Francis Mhimbira, Maja Weisser and Martin Rohacek.

They worked alongside Fiona Vanobberghen, Klaus Reither, Daniel H. Paris and Manuel Battegay from Swiss TPH and the University of Basel; Winfrid Gingo from St Francis Referral Hospital in Ifakara and Irene B. Kato from Mwananyamala Regional Referral Hospital in Dar es Salaam.

“Patients with suspected extrapulmonary tuberculosis are often treated empirically. We hypothesized that eFASH, in combination with other tests, would increase the proportion of correctly managed patients with suspected extrapulmonary tuberculosis,” they report.

Adding to these observations, they also wrote in the paper that: “In this randomized controlled trial on the effect of eFASH on the management of persons suspected to have extrapulmonary TB, we did not find differences in the correct management, absence of symptoms or mortality among participants randomized to the intervention compared to standard of care. We found a significant difference in the proportion of definite TB between groups.”

From September 26, 2018, through October 19, 2020, a total of 1,036 patients – from St. Francis Referral Hospital in Ifakara and Mwananyamala Regional Referral Hospital in Dar – were screened and 701 were enrolled and randomized (350 to the intervention, 351 to the control group). Follow-up lasted until March 31, 2021. 251 (72%) intervention participants had a positive eFASH.

Recent data show that TB is one of the main causes of death worldwide. In 2020 alone, only one-third of people in low-income countries treated for TB were microbiologically confirmed. This is partly due to limited access to diagnostics or tests that have a low sensitivity for extrapulmonary TB, and for TB in both HIV-infected individuals and children.

As a result, empirical treatments for TB have routinely been practiced leading to overtreatment among people who might not have the disease and a delay in the diagnosis of other conditions with similar clinical presentations as extrapulmonary tuberculosis.

“We are very happy that the results from the eFASH study (clinical trial on the value of sonography in diagnosis of extrapulmonary TB) have just been published in the Clinical Infectious Diseases. Not only this is a high-impact journal, it is also the journal, which is read mostly by infectious disease clinical community,” comments one of the authors, Prof. Maja Weisser.
 
“The eFASH trial is one of the largest diagnostic trials on extrapulmonary Tuberculosis done so far. And even if the overall result was a negative finding - the primary outcome of 'correct diagnosis and management' could not be improved by sonography, the diagnostic yield could be greatly improved, which is epidemiologically and clinically relevant,” she adds.

>> Read the Article: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciac871/6801068?searchresult=1