An Observational Study of Fungal Biomarkers (MK-0000-089)
4 de agosto de 2015 atualizado por: Merck Sharp & Dohme LLC
A Prospective, Non-Intervention, Observational Assessment of the Correlation Between Circulating Biomarkers of Fungal Bioburden and Clinical Outcome in the Setting of Invasive Aspergillosis
The purpose of this study is to evaluate the relationship between fungal biomarker levels during anti-fungal therapy and the success of treatment for fungal infection.
The primary hypothesis is that over the initial two weeks of anti-fungal therapy, fungal biomarkers from participants with invasive aspergillosis (IA) will be lower for those with a successful clinical outcome compared to those with a failed clinical outcome.
Visão geral do estudo
Tipo de estudo
Observacional
Inscrição (Real)
116
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
16 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Participants will be selected through collaborations with clinicians.
Descrição
Inclusion Criteria:
- Is 16 years of age or older
- Female is either post-menopausal, surgically sterilized, willing to use 2 adequate methods of birth control, or agrees to abstain from heterosexual activity throughout the study
- Female of child bearing potential must have a negative pregnancy test
- Male is surgically sterilized, agrees to use an adequate method of contraception, or agrees to abstain from heterosexual activity for the duration of the study
- Has possible, probable, or confirmed invasive aspergillosis (IA)
- Has had a computed tomography (CT) or magnetic resonance imaging (MRI) scan 72 hours prior to initiation of anti-fungal therapy
Exclusion Criteria:
- Has had hemodialysis using cellulose membrane within 2 weeks of study start
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Invasive Aspergillosis
Observational
|
Blood samples will be collected for 12 weeks to evaluate levels of fungal biomarkers.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Average of the Z-scores of the Time-Weighted Averages (TWA) of Fungal Biomarkers Galactomannan (GM) and (1,3)-β-D-glucan (βDG) Over the First Two Weeks of Treatment for Responders (R) and Non-Responders (NonR) to Anti-fungal Treatment at Week 6.
Prazo: Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall standard deviation (SD).
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Average of the Z-scores of the Slopes of Least-Squares Straight Lines (SLSSL) Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Prazo: Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the TWA of the Changes From Baseline (CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Prazo: Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD.
The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the Percent Changes From Baseline (%CFB) of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Prazo: Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD.
The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Prazo: Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the TWA of the CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Prazo: Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA CFB divided by the overall SD.
The average of the Z-scores of the TWA CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of %CFB of Fungal Biomarkers GM and βDG Over the First Two Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Prazo: Weeks 1 and 2
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for biomarker analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual %CFB divided by the overall SD.
The average of the Z-scores of the %CFB for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 and 2
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Prazo: Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Prazo: Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Prazo: Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First Week of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Prazo: Week 1
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Week 1
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Prazo: Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
|
Average of the Z-scores of the TWA of Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Prazo: Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual TWA divided by the overall SD.
The average of the Z-scores of the TWA for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 6.
Prazo: Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
|
Average of the Z-scores of the SLSSL Fitted to the Fungal Biomarkers GM and βDG Over the First 6 Weeks of Treatment for R and NonR to Anti-fungal Treatment at Week 12.
Prazo: Weeks 1 through 6
|
After enrollment blood was collected at baseline, twice per week for the first six weeks, then weekly through twelve weeks for analysis of biomarkers GM and βDG.
Clinical outcome was assessed for qualified participants at 6 and 12 weeks after initiation of antifungal treatment.
For a given biomarker the Z-score is the difference from the mean of each individual SLSSL divided by the overall SD.
The average Z-scores of the SLSSL for qualified participants is then calculated across all biomarkers, and used to derive the mean for R and NonR to antifungal therapy.
|
Weeks 1 through 6
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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 março de 2009
Conclusão Primária (Real)
1 de junho de 2011
Conclusão do estudo (Real)
1 de agosto de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
27 de fevereiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de fevereiro de 2009
Primeira postagem (Estimativa)
3 de março de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de agosto de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de agosto de 2015
Última verificação
1 de agosto de 2015
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0000-089
- 2009_553 (Outro identificador: Merck)
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 .
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