Mycobacterial Lung Diseases in Virginia: Sequencing and Clinical Determinants of Relapse and Outcome
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Nontuberculous mycobacterial (NTM) lung diseases, primarily due to M. avium complex (MAC), are an increasing clinical problem nationwide and now overtake domestic TB in terms of morbidity and mortality. It is also harder to treat and results in poorer outcomes despite longer drug regimens. In this project we utilize a state-wide clinical cohort of NTM lung disease patients to understand what features of the organism (such as the species or subtype or drug resistance profile), the host (such as antibiotic drug absorption), and the environment (such as household exposure to NTM) are most important in predicting clinical outcome. The sum of this research will direct future therapies and management algorithms for this difficult disease.
First, we will perform whole genome sequencing of NTM isolates to discern relapse versus reinfection and the environmental sources of acquisition. Second, we will utilize a state-wide cohort of new and prior diagnosed NTM lung disease patients, starting initial therapy to correlate clinical outcomes with NTM species, drug susceptibility, other bacterial in vitro assays, and serum drug levels.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sharon F Johnson
- Numéro de téléphone: 434-982-3413
- E-mail: sfj8n@virginia.edu
Sauvegarde des contacts de l'étude
- Nom: Eric F Houpt, MD
- Numéro de téléphone: 434-924-5167
- E-mail: ERH6K@virginia.edu
Lieux d'étude
-
-
Virginia
-
Charlottesville, Virginia, États-Unis, 22908
- Recrutement
- University of Virginia, Division of Infectious Disease
-
Contact:
- Sharon F Johnson
- Numéro de téléphone: 434-982-3413
- E-mail: sfj8n@virginia.edu
-
Chercheur principal:
- Eric Houpt, MD
-
Sous-enquêteur:
- Scott Heysell, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
All subjects:
- Race/ethnicity: any
- Subject has no history of active Tuberculosis in the last 2 years.
- NTM culture positive from respiratory specimen (sputum or bronchial lavage fluid)
- Subject must have an available sputum sample that was taken in the last 2 years. If a sample is not available, the subject must be willing and able to provide a sputum sample.
Meets the following Infectious Diseases Society of America (IDSA) criteria for NTM lung disease:
- 2 or more sputum (or 1 bronchoscopy/biopsy) cultures positive for "Mycobacterium Avium Complex" or "Mycobacterium abscessus) within the last 2 years.
- Nodules, cavities, and/or bronchiectasis on CT scan within the past 2 years
- If if the above data are not available, but a patient's Infectious Disease or Pulmonary physician has documented the diagnosis of NTM lung disease in their notes, this will suffice
PK subjects:
- Newly diagnosed with NTM lung disease and beginning antibiotics for NTM within the last 3 months from enrollment.
- Prior diagnosis of NTM lung disease, and starting initial therapy within the last 3 months prior to enrollment.
- Consent to pharmacokinetic testing within one month of enrollment and at six months of therapy
Exclusion Criteria:
- List the criteria for exclusion
All subjects:
- Age < 18 years
- Subject has cystic fibrosis or other inherited disorders of airway ciliary dysfunction (eg, primary ciliary dyskinesia)
- Unable to participate in follow-up requirements by phone or clinic visit
PK subjects:
• Unable to have blood drawn for pharmacokinetic testing
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Aim 1
Délai: 5 years
|
Relapse versus reinfection: Perform whole genome sequencing of NTM isolates from lung disease patients from across Virginia to discern relapse versus reinfection and environmental sources of acquisition.
|
5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Aim 2
Délai: 5 years
|
Patient outcomes: Utilizing the cohort of new and prior diagnosed NTM lung disease patients that have started initial therapy within the last 3 months from across Virginia, compare conventional drug susceptibility (MIC) versus pharmacokinetics/pharmacodynamics (PK/PD) indices in predicting NTM species-specific clinical outcomes.
|
5 years
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB200232
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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 .