Tuberculosis Clinical Trial
Official title:
Small Membrane Filtration (SMF) Method to Improve the Performance of Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis in a High HIV Prevalence Setting
This study is investigating a better method to see if someone has tuberculosis (TB) as compared to the method that is being used now.
TB is a disease caused by a bacterium called Mycobacterium tuberculosis that can affect the
lungs or other parts of the body. In most of the world and in Mbarara, Uganda, the method of
diagnosis that is used is AFB smear microscopy. This method is widely available, inexpensive
and rapid. However, this method's ability to truly detect people having TB is poor. That is,
if someone has TB, the test results may say that they are negative, leading to delays in
diagnosis, disease progression, and an ongoing transmission of the bacteria.
The new test for TB diagnosis we are studying is called the Small Membrane Filtration (SMF)
method. This test that is being compared to the method currently being used and is very
similar to the one that is currently used (standard smear microscopy) but has the advantage
of concentrating the sputum (mucus) so that we can more easily see if bacteria are present
in the sputum. It is hoped that a better way of knowing if someone has TB will help doctors
decide when people need to be treated for TB and when not, which will improve the health of
patients and help avoid passing the infection to others.
This study will enroll 740 HIV-infected and 310 HIV-uninfected adults with culture confirmed
pulmonary TB. These individuals will be identified prospectively at two TB clinics in
Mbarara, Uganda.
Study hypothesis: The investigators will assume that one sputum sample will be equivalent to
two (null hypothesis) with respect to sensitivity unless we have evidence that the use of
two has higher sensitivity (alternative hypothesis). The investigators will assume that SMF
is equivalent to AFB smear with respect to sensitivity and specificity unless the
investigators find evidence it is superior. The investigators will assume that SMF is
equivalent to Xpert unless the investigators find evidence that Xpert is superior.
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Time Perspective: Cross-Sectional
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