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Evaluation of high-dose rifampin in patients with new, smear-positive tuberculosis (HIRIF): study protocol for a randomized controlled trial.

Abstract：

BACKGROUND:Evidence has existed for decades that higher doses of rifampin may be more effective, but potentially more toxic, than standard doses used in tuberculosis treatment. Whether increased doses of rifampin could safely shorten treatment remains an open question. METHODS/DESIGN:The HIRIF study is a phase II randomized trial comparing rifampin doses of 20 and 15 mg/kg/day to the standard 10 mg/kg/day for the first 2 months of tuberculosis treatment. All participants receive standard doses of companion drugs and a standard continuation-phase treatment (4 months, 2 drugs). They are followed for 6 months post treatment. Study participants are adults with newly diagnosed, previously untreated, smear positive (≥2+) pulmonary tuberculosis. The primary outcome is rifampin area under the plasma concentration-time curve (AUC0-24) after at least 14 days of study treatment/minimum inhibitory concentration. 180 randomized participants affords 90 % statistical power to detect a difference of at least 14 mcg/mL*hr between the 20 mg/kg group and the 10 mg/kg group, assuming a loss to follow-up of up to 17 %. DISCUSSION:Extant evidence suggests the potential for increased doses of rifampin to shorten tuberculosis treatment duration. Early studies that explored this potential using intermittent, higher dosing were derailed by toxicity. Given the continued large, global burden of tuberculosis with nearly 10 million new cases annually, shortened regimens with existing drugs would offer an important advantage to patients and health systems. TRIAL REGISTRATION:This trial was registered with clinicaltrials.gov (registration number: NCT01408914 ) on 2 August 2011.

journal_name

BMC Infect Dis

journal_title

BMC infectious diseases

authors

Milstein M,Lecca L,Peloquin C,Mitchison D,Seung K,Pagano M,Coleman D,Osso E,Coit J,Vargas Vasquez DE,Sanchez Garavito E,Calderon R,Contreras C,Davies G,Mitnick CD

doi

10.1186/s12879-016-1790-x

subject

Has Abstract

pub_date

2016-08-27 00:00:00

pages

453

issue

issn

1471-2334

pii

10.1186/s12879-016-1790-x

journal_volume

pub_type

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Evaluation of high-dose rifampin in patients with new, smear-positive tuberculosis (HIRIF): study protocol for a randomized controlled trial.