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POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)

13 de março de 2017 atualizado por: Merck Sharp & Dohme LLC

A Multicenter, Randomized, Controlled, Double-Blind, Double-Dummy, Two-Arm Study of Posaconazole vs Fluconazole in the Treatment of Coccidioidomycosis

To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants received posaconazole for a treatment duration not to exceed 12 months.

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Intervencional

Inscrição (Real)

16

Estágio

  • Fase 3

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

13 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Thirteen years of age or older, 34 kg (75 lb) or more, either sex, and any race;
  • Coccidioides immitis (C. immitis) or Coccidioides posadasii (C. posadasii) identified by culture or microscopic examination from skeletal disease, chronic active pulmonary disease, or soft tissue disease;
  • Coccidioidomycosis score of >=6;
  • Clinical laboratory safety tests within normal limits or clinically acceptable to the sponsor;
  • Free of any clinically significant disease that would interfere with study evaluations;
  • Willing to give written informed consent and able to adhere to study medication dose, mandatory procedures (including human immunodeficiency virus (HIV) testing), and visit schedules;
  • Able to swallow food or a nutritional supplement;
  • Use of a medically accepted method of contraception;
  • Negative serum pregnancy test at Screening and negative urine pregnancy test at Randomization;
  • Women of childbearing potential not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.

Exclusion Criteria:

  • Key Exclusion Criteria

Excluded Medications at Enrollment

  • Medications that are known to interact with POS or FLU and that may lead to serious or life threatening side effects within 7 days prior to initiating study drug;
  • Medications known to lower the serum concentration/efficacy of azole antifungals within 7 days prior to study drug start;
  • Prior investigational drug use or biologic product administration within 30 days before study drug start;
  • Prior antifungal treatment for the current episode of infection with a total cumulative dose of >=8 g of any azole, >=4 mg/kg of amphotericin B deoxycholate, or >=20 mg/kg of lipid amphotericin B;
  • Antiretrovirals that are substrates of CYP3A4 administered to HIV-positive subjects, as it is not currently known how POS or FLU may affect such drugs or the potential to cause adverse reactions.

    • Excluded Concomitant Conditions
  • Immediately life-threatening coccidioidomycosis;
  • Confirmed or suspected meningeal coccidioidomycosis;
  • Pulmonary coccidioidomycosis in HIV-negative subjects for less than 3 months;
  • Any condition requiring use of prohibited drugs;
  • Cluster of Differentiation 4 (CD4) count of <200 cells/mm3 or any auto-immune deficiency syndrome (AIDS)-defining illness in HIV-positive subjects in the prior 30 days.

    • Excluded Baseline Laboratory Studies
  • Moderate or severe liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times upper limit of normal (ULN)) or a total bilirubin level or direct bilirubin > 3 times ULN plus ALT or AST >2 times ULN (Hy's Rule);
  • Moderate or severe renal dysfunction (creatinine clearance (CrCl) <20 mL/min) or dialysis required or expected to be required within the study period;
  • Electrocardiogram (ECG) with a prolonged QTc interval by manual reading: QTc >450 msec for males and QTc >470 msec for females.

    • General Exclusion Criteria
  • Prior enrollment in this study or other POS studies;
  • Failed treatment with FLU or POS at any time in the past;
  • History of hypersensitivity or idiosyncratic reactions to azole drug therapy;
  • Women who are pregnant, intend to become pregnant, or are breast-feeding;
  • Situation or condition that may interfere with optimal participation in the study;

Part of the staff personnel directly involved with this study;

  • Family member of the investigational study staff.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Posaconazole
Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months
Comparador Ativo: Fluconazole
Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A.
Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A
Prazo: 12 months

Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.

Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication.

12 months
Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B
Prazo: 12 months

Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.

Treatment-related adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state and are judged by the investigator to be possibly, probably or definitely related to study medication.

12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A
Prazo: 12 months
Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.
12 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B
Prazo: 12 months
Treatment-emergent adverse events are defined as new events that occur following subject entry into the study or events that worsen following study entry state.
12 months
Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A
Prazo: 12 months
Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.
12 months
Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B
Prazo: 12 months
Severity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE; Grade 2 Moderate AE; Grade 3 Severe AE; Grade 4 Life-threatening or disabling AE; Grade 5 Death related to AE.
12 months
Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A
Prazo: 12 months
12 months
Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B
Prazo: 12 months
12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2007

Conclusão Primária (Real)

1 de maio de 2009

Conclusão do estudo (Real)

1 de maio de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

17 de janeiro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de janeiro de 2007

Primeira postagem (Estimativa)

18 de janeiro de 2007

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de abril de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

13 de março de 2017

Última verificação

1 de março de 2017

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Posaconazole

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