RESUMO
Background: By the early 1980s, tuberculosis treatment was shortened from 24 to 6 months, maintaining relapse rates of 1-2%. Subsequent trials attempting shorter durations have failed, with 4-month arms consistently having relapse rates of 15-20%. One trial shortened treatment only among those without baseline cavity on chest x-ray and whose month 2 sputum culture converted to negative. The 4-month arm relapse rate decreased to 7% but was still significantly worse than the 6-month arm (1.6%, P<0.01). We hypothesize that PET/CT characteristics at baseline, PET/CT changes at one month, and markers of residual bacterial load will identify patients with tuberculosis who can be cured with 4 months (16 weeks) of standard treatment. Methods: This is a prospective, multicenter, randomized, phase 2b, noninferiority clinical trial of pulmonary tuberculosis participants. Those eligible start standard of care treatment. PET/CT scans are done at weeks 0, 4, and 16 or 24. Participants who do not meet early treatment completion criteria (baseline radiologic severity, radiologic response at one month, and GeneXpert-detectable bacilli at four months) are placed in Arm A (24 weeks of standard therapy). Those who meet the early treatment completion criteria are randomized at week 16 to continue treatment to week 24 (Arm B) or complete treatment at week 16 (Arm C). The primary endpoint compares the treatment success rate at 18 months between Arms B and C. Discussion: Multiple biomarkers have been assessed to predict TB treatment outcomes. This study uses PET/CT scans and GeneXpert (Xpert) cycle threshold to risk stratify participants. PET/CT scans are not applicable to global public health but could be used in clinical trials to stratify participants and possibly become a surrogate endpoint. If the Predict TB trial is successful, other immunological biomarkers or transcriptional signatures that correlate with treatment outcome may be identified. TRIAL REGISTRATION: NCT02821832.
RESUMO
BACKGROUND: It is estimated that there are about 74,000 primary multidrug-resistant tuberculosis (MDR-TB) patients per year according to the prevalence of MDR-TB of 5.7% among new TB patients in China. Thus, the risks of primary transmission of MDR-TB require further attention. This study aimed to identify the factors associated with primary transmission of MDR-TB in Henan province, where the number of new TB patients is ranked second highest in China. METHODS: A 1:1 matched case-control study was conducted in Henan, China. Cases were primary MDR-TB patients who were individually matched with a healthy control without TB from the same neighborhood. The study was conducted from July 2013 to June 2014. Both case and control were matched by age (±5 years) and sex. Conditional logistic regression was used to compute adjusted odds ratios (AORs) with corresponding 95% confidence intervals (CIs) for risk factors associated with primary MDR-TB. RESULTS: For the study, 146 pairs of participants were recruited. The final multivariable logistic regression model disclosed that after adjusting for age and sex, primary MDR-TB cases were more likely to be single (AOR, 5.4; 95% CI, 1.4-20.7), earn an annual income of ≤ 12,000 yuan (RMB) (AOR, 9.9; 95% CI, 2.0-48.1), experience more life pressure/stress (AOR, 10.8; 95% CI, 2.8-41.5), not be medically insured (AOR, 50.1; 95% CI, 8.2-306.8), and suffer from diabetes, cardiovascular disease or other respiratory diseases, or cancer (AOR, 57.1; 95% CI, 8.6-424.2). CONCLUSIONS: In order to control primary transmission of MDR-TB in China, we recommend that improving the social support, living standards and medical security of the lower social class become a priority.