Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis was written by Goodall, Ruth L.;Sanders, Karen;Bronson, Gay;Gurumurthy, Meera;Torrea, Gabriela;Meredith, Sarah;Nunn, Andrew;Rusen, I. D.;on behalf of the STREAM Trial Team. And the article was included in Trials in 2022.Safety of 8-(n-(4-methyl-1-piperazinyl)formidoyl)-rifomycins This article mentions the following:
Results from the STREAM stage 1 trial showed that a 9-mo regimen for patients with rifampicin-resistant tuberculosis was non-inferior to the 20-mo regimen recommended by the 2011 WHO treatment guidelines. Similar levels of severe adverse events were reported on both regimens suggesting the need for further research to optimize treatment. Stage 2 of STREAM evaluates two addnl. short-course regimens, both of which include bedaquiline. Throughout stage 2 of STREAM, new drug choices and a rapidly changing treatment landscape have necessitated changes to the trial’s design to ensure it remains ethical and relevant. This paper describes changes to the trial design to ensure that stage 2 continues to answer important questions. These changes include the early closure to recruitment of two trial arms and an adjustment to the definition of the primary endpoint. If the STREAM exptl. regimens are shown to be non-inferior or superior to the stage 1 study regimen, this would represent an important contribution to evidence about potentially more tolerable and more efficacious MDR-TB regimens, and a welcome advance for patients with rifampicin-resistant tuberculosis and tuberculosis control programs globally. In the experiment, the researchers used many compounds, for example, 8-(n-(4-methyl-1-piperazinyl)formidoyl)-rifomycins (cas: 13292-46-1Safety of 8-(n-(4-methyl-1-piperazinyl)formidoyl)-rifomycins).
8-(n-(4-methyl-1-piperazinyl)formidoyl)-rifomycins (cas: 13292-46-1) belongs to piperazine derivatives. The piperazine scaffold is often found in biologically active compounds in different therapeutic areas. These therapeutic areas include antifungals, antidepressants, antivirals, and serotonin receptor (5-HT) antagonists/agonists. Although many piperazine derivatives occur naturally, piperazine itself can be synthesized by reacting alcoholic ammonia with 1,2-dichloroethane, by the action of sodium and ethylene glycol on ethylene diamine hydrochloride, or by reduction of pyrazine with sodium in ethanol.Safety of 8-(n-(4-methyl-1-piperazinyl)formidoyl)-rifomycins
Referemce:
Piperazine – Wikipedia,
Piperazines – an overview | ScienceDirect Topics