Abstract
Standard treatment of drug-sensitive pulmonary tuberculosis requires six months of treatment. Several randomized clinical trials have attempted to shorten treatment to four months using various strategies but thus far all have failed. The PredictTB trial is an ongoing international randomized clinical trial testing a treatment shortening strategy whereby only drug-sensitive pulmonary TB patients who meet the study early treatment completion criteria are randomized to four vs. six months of treatment. The PredictTB early treatment completion criteria were developed based on a cohort of 92 pulmonary tuberculosis patients treated programmatically through the local tuberculosis treatment program in Cape Town, South Africa, with FDG-PET/CT scans also performed at baseline and week 4 of treatment. Patients were followed for one year after the end of therapy for programmatic treatment outcomes. This methodology paper describes how the PET/CT scans and GeneXpert cycle threshold data of this cohort were analyzed to develop the early treatment completion algorithm currently being used in the PredictTB trial.
Highlights
Multiple clinical trials over the last 40 years attempting to shorten therapy for pulmonary, drug-sensitive tuberculosis from six to four months have failed[1,2,3,4]
The PredictTB early treatment completion criteria were developed based on a cohort of 92 pulmonary tuberculosis patients treated programmatically through the local tuberculosis treatment program in Cape Town, South Africa, with FDG-positron emission tomography/computed tomography (PET/CT) scans performed at baseline and week 4 of treatment
Previously conducted treatment shortening studies for drug sensitive TB (DS-TB) suggested that approximately 80-85% of patients are cured with four months of treatment[1,2,3,4]
Summary
Multiple clinical trials over the last 40 years attempting to shorten therapy for pulmonary, drug-sensitive tuberculosis from six to four months have failed[1,2,3,4]. Two subsequent secondary analyses of the three fluoroquinolone treatment shortening trials[2,3,4] support this premise by finding that a subset of lower risk participants, those without cavity on baseline chest-x-ray, acid-fast bacilli (AFB) smear less than 2+ at baseline, or AFB smear negative at month 2 of treatment were associated with successful four-month treatment outcomes[6,7]. Another trial prospectively attempted a similar risk stratification by shortening treatment for those without cavity on baseline chest x-ray, a measure of baseline risk, and those with negative sputum cultures at two months of treatment, a measure of treatment response[8]. The PredictTB trial was developed on the hypothesis that more precise methods of evaluating baseline risk and treatment response will successfully identify lower risk participants cured with four months of treatment
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