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Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis Instituut voor Tropische Geneeskunde

Ruth L. Goodall, Karen Sanders, Gay Bronson, Meera Gurumurthy, Sarah Meredith, Andrew Nunn, I. D. Rusen

Results from the STREAM stage 1 trial showed that a 9-month regimen for patients with rifampicin-resistant tuberculosis was non-inferior to the 20-month 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 optimise treatment. Stage 2 of STREAM evaluates two additional short-course regimens, both of which include bedaquiline. ...

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial Instituut voor Tropische Geneeskunde

L. Guglielmetti, Elisa Ardizzoni, M. Atger, E. Baudin, E. Berikova, M. Bonnet, E. Chang, Sandrine Cloez, J. M. Coit, J Cox, et al.

BACKGROUND: Treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) is expensive, labour-intensive, and associated with substantial adverse events and poor outcomes. While most MDR/RR-TB patients do not receive treatment, many who do are treated for 18 months or more. A shorter all-oral regimen is currently recommended for only a sub-set of MDR/RR-TB. Its use is only conditionally recommended because of very low-quality ...

Evaluating newly approved drugs in combination regimens for multidrug-resistant tuberculosis with fluoroquinolone resistance (endTB-Q): study protocol for a multi-country randomized controlled trial Instituut voor Tropische Geneeskunde

Praharshinie Rupasinghe, S. B. Patil, M. Tamirat, K Khazhidinov, Elisa Ardizzoni, M. Atger, A Austin, E. Baudin, M Bekhit, S Bektasov, et al.

BACKGROUND: Treatment for fluoroquinolone-resistant multidrug-resistant/rifampicin-resistant tuberculosis (pre-XDR TB) often lasts longer than treatment for less resistant strains, yields worse efficacy results, and causes substantial toxicity. The newer anti-tuberculosis drugs, bedaquiline and delamanid, and repurposed drugs clofazimine and linezolid, show great promise for combination in shorter, less-toxic, and effective regimens. To date, ...

High rate of adverse drug reactions with a novel tuberculosis retreatment regimen combining triple-doses of both isoniazid and rifampicin Instituut voor Tropische Geneeskunde

Mahamadou Bassirou Souleymane, Sani Kadri, Alberto Piubello, Achilleas Tsoumanis, Alphazazi Soumana, Hamidou Issa, Abdoulaziz Kabirou Amoussa, Armand Van Deun, Lut Lynen, Bouke de Jong, et al.

OBJECTIVES: High-dose rifampicin (R) and isoniazid (H) are known to be safe but were not yet combined in a single regimen. The primary objective of the TRIple-DOse RE-treatment (TRIDORE) study is to determine whether a 6-month firstline regimen with triple dose of both R and H (intervention arm; 6R 3H 3ZE) is non-inferior in terms of safety compared to a normal-dose regimen (6RHZE) in previously treated patients with R-susceptible (Rs) ...

Prednisone for the prevention of paradoxical tuberculosis-associated IRIS Instituut voor Tropische Geneeskunde Universiteit Antwerpen

Graeme Meintjes, Cari Stek, Lisette Blumenthal, Friedrich Thienemann, Charlotte Schutz, Raffaella Ravinetto, Harry van Loen, Amy Nair, Amanda Jackson, Robert Colebunders, et al.

BACKGROUND: Early initiation of antiretroviral therapy (ART) in human immunodeficiency virus (HIV)-infected patients who have tuberculosis reduces mortality among patients with low CD4 counts, but it increases the risk of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome (IRIS).

METHODS: We conducted this randomized, double-blind, placebo-controlled trial to assess whether prophylactic prednisone can ...