Original articleControlled clinical trial of 4 short-course regimens of chemotherapy (three 6-month and one 8-month) for pulmonary tuberculosis: Final report
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High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis: Study protocol for TBTC study 31/ACTG A5349 phase 3 clinical trial
2020, Contemporary Clinical TrialsCitation Excerpt :A 6% margin of non-inferiority has been used in other recent trials of single-drug substitution treatment shortening trials (REMoxTB, OFLOTUB, RIFAQUIN) [24,50,51]. The justification of the 6% margin is published in the online supplements with those papers and is based on a meta-analysis of historical trials including six-month or four-month rifampin-based regimens [53–57]. The extension from 6% to the 6.6% as used in our trial is based on the following statistical and clinical considerations.
Pan-tuberculosis regimens: an argument against
2018, The Lancet Respiratory MedicinePyrazinamide pharmacokinetics and efficacy in adults and children
2012, TuberculosisCitation Excerpt :Thus a dosage of PZA of 1.5 g daily was more efficacious than the same dosage given in three divided doses daily and this was linked to the attainment of serum PZA concentrations of ≥30 μg/mL following the higher dosage. From the perspective of this review it should be noted that the dosage of PZA used in early studies was 2 g daily in a single dose for all patients.11,18 Other studies in East Africa and Asia gave a daily dosage of 2 g for patients weighing 50 kg or more and 1.5 g for those <50 kg19,20 Accepting the weight of pulmonary tuberculosis patients as ranging from 40 kg to 60 kg the dosage of PZA used would have ranged from 1.5 g for a 40 kg patient, or 37.5 mg/kg bodyweight, declining with increases in body weight to 31 mg/kg for a 49 kg patient, to 2 g for a 50 kg patient or 40 mg/kg with the dosage in mg/kg body weight again declining with every increase in body weight to 33 mg/kg for a 60 kg patient.