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- Registre américain des essais cliniques
- Essai clinique NCT00854607
An Observational Study of Fungal Biomarkers (MK-0000-089)
4 août 2015 mis à jour par: 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.
Aperçu de l'étude
Type d'étude
Observationnel
Inscription (Réel)
116
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
16 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Participants will be selected through collaborations with clinicians.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Invasive Aspergillosis
Observational
|
Blood samples will be collected for 12 weeks to evaluate levels of fungal biomarkers.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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.
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 mars 2009
Achèvement primaire (Réel)
1 juin 2011
Achèvement de l'étude (Réel)
1 août 2011
Dates d'inscription aux études
Première soumission
27 février 2009
Première soumission répondant aux critères de contrôle qualité
27 février 2009
Première publication (Estimation)
3 mars 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
21 août 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 août 2015
Dernière vérification
1 août 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0000-089
- 2009_553 (Autre identifiant: Merck)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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