Four-Month High-Dose Rifampicin Regimens for Pulmonary Tuberculosis
نویسندگان
چکیده
BackgroundShorter but effective tuberculosis treatment regimens would be of value to the community. High-dose rifampicin has been associated with more rapid and secure lung sterilization may enable shorter regimens.MethodsWe randomly assigned adults who were given a diagnosis rifampicin-susceptible pulmonary 6-month control regimen, similar 4-month regimen at 1200 mg/d (study 1 [SR1]), or 1800 2 [SR2]). Sputum specimens collected regular intervals. The primary end point was composite failure relapse in participants sputum smear positive baseline. noninferiority margin 8 percentage points. Using sequence ordered hypotheses, SR2 tested first.ResultsBetween January 2017 December 2020, 672 patients enrolled six countries, including 191 group, 192 SR1 195 group. Noninferiority not shown. Favorable responses rates 93, 90, 87% control, SR1, groups, respectively, for country-adjusted absolute risk difference 6.3 points (90% confidence interval, 1.1 11.5) comparing proportions experiencing grade 3 4 adverse event 4.0, 4.5, 4.4% respectively.ConclusionsFour-month high-dose did have dose-limiting toxicities side effects failed meet criteria compared standard tuberculosis. (Funded by MRC/Wellcome Trust/DFID Joint Global Health Trials Scheme; ClinicalTrials.gov number, NCT02581527.)
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ژورنال
عنوان ژورنال: NEJM evidence
سال: 2023
ISSN: ['2766-5526']
DOI: https://doi.org/10.1056/evidoa2300054