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DOI 10.1016/j.conctc.2021.100745

Медицинская библиотека · Contemporary clinical trials communications · 2021

Randomized, phase 1/2, double-blind pioglitazone repositioning trial combined with antifungals for the treatment of cryptococcal meningitis - PIO study.

Gouveia-Eufrasio Ludmila, Ribeiro Noelly Queiroz, Santos Julliana Ribeiro Alves, da Costa Marliete Carvalho, Emídio Elúzia Castro Peres, de Freitas Gustavo José Cota, do Carmo Paulo Henrique Fonseca, Miranda Bárbara Alves, de Oliveira João Carlos Maia Dornelas, da Silva Lívia Mara Vitorino, Teixeira Leocádio Victor Augusto, Randi Magalhães Vanessa Caroline, Penido Indiara, Pereira Leonardo Soares, Rabelo Lívia Frota, de Almeida Faria Flávio Augusto, Teixeira Dutra Maria Rita, Aspahan Maíra, de Paula Ludmila, da Silva Dirce Inês, Tavares Melo Márcia Gregory, de Andrade Zambelli Virginia Antunes, Gomes Faraco André Augusto, da Costa César Isabela, Alves Glauciene Prado, da Cunha Melo Lívia Fulgêncio, de Aguiar Peres Nalu Teixeira, Santos Daniel Assis

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Аннотация

BACKGROUND

Cryptococcosis affects more than 220,000 patients/year, with high mortality even when the standard treatment [amphotericin B (AMB), 5-flucytosin (5-FC) and fluconazole] is used. AMB presents high toxicity and 5-FC is not currently available in Brazil. In a pre-clinical study, pioglitazone (PIO - an antidiabetic drug) decreased AMB toxicity and lead to an increased mice survival, reduced morbidity and fungal burden in brain and lungs. The aim of this trial is to evaluate the efficacy and safety of PIO combined with standard antifungal treatment for human cryptococcosis.

METHODS

A phase 1/2, randomized, double blind, placebo-controlled trial will be performed with patients from Belo Horizonte, Brazil. They will be divided into three groups (placebo, PIO 15 mg/day or PIO 45 mg/day) and will receive an additional pill during the induction phase of cryptococcosis' treatment. Our hypothesis is that treated patients will have increased survival, so the primary outcome will be the mortality rate. Patients will be monitored for survival, side effects, fungal burden and inflammatory mediators in blood and cerebrospinal fluid. The follow up will occur for up 60 days.

CONCLUSIONS

We expect that PIO will be an adequate adjuvant to the standard cryptococcosis' treatment.

TRIAL REGISTRATION: ICTRP/WHO (and International Clinical Trial Registry Plataform (ICTRP/WHO) (http://apps.who.int/trialsearch/Trial2.aspx?TrialID=RBR-9fv3f4), RBR-9fv3f4 (http://www.ensaiosclinicos.gov.br/rg/RBR-9fv3f4). UTN Number: U1111-1226-1535. Ethical approvement number: CAAE 17377019.0.0000.5149.

Для цитирования: Gouveia-Eufrasio Ludmila, Ribeiro Noelly Queiroz, Santos Julliana Ribeiro Alves, da Costa Marliete Carvalho, Emídio Elúzia Castro Peres, de Freitas Gustavo José Cota, do Carmo Paulo Henrique Fonseca, Miranda Bárbara Alves, de Oliveira João Carlos Maia Dornelas, da Silva Lívia Mara Vitorino, Teixeira Leocádio Victor Augusto, Randi Magalhães Vanessa Caroline, Penido Indiara, Pereira Leonardo Soares, Rabelo Lívia Frota, de Almeida Faria Flávio Augusto, Teixeira Dutra Maria Rita, Aspahan Maíra, de Paula Ludmila, da Silva Dirce Inês, Tavares Melo Márcia Gregory, de Andrade Zambelli Virginia Antunes, Gomes Faraco André Augusto, da Costa César Isabela, Alves Glauciene Prado, da Cunha Melo Lívia Fulgêncio, de Aguiar Peres Nalu Teixeira, Santos Daniel Assis. Randomized, phase 1/2, double-blind pioglitazone repositioning trial combined with antifungals for the treatment of cryptococcal meningitis - PIO study.. Contemporary clinical trials communications. 2021. DOI: 10.1016/j.conctc.2021.100745.
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