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- Registre américain des essais cliniques
- Essai clinique NCT01033955
Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Primary Objective: The primary objective of the CHAT Pilot Trial is to assess our ability to recruit the desired patient population (i.e., the proportion of eligible patients enrolled in the trial), and to conduct a scientifically rigorous international RCT under pandemic circumstances.
Secondary Objectives: To evaluate (i) adherence to the medication administration regimen. (ii) the ability for research staff to collect the required primary and secondary endpoints for the planned full CHAT trial, (iii) the number of study withdrawals due to administration of open-label statins and withdrawals of consent and (iv) the impact of the approved consent model on recruitment rates.
Study Methods (Overview): Using a web-based randomization system patients, research coordinators will assign critically ill adults treated with antiviral medication for < or equal to 72 hours and requiring mechanical ventilation to one of two treatment strategies (rosuvastatin or placebo) for 14 days. Given the need to recruit patients into the CHAT Trial under pandemic conditions, when family members may not be present to provide written informed consent, we will request either a waiver of consent or deferred consent from Research Ethics Boards (REBs) at participating centres. The Keenan Research Centre/Li Ka Shing Knowledge Institute (St Michael's Hospital, Toronto, Ontario) will be the study Methods Centre.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St. Paul's Hospital
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3B 0Z3
- Health Sciences Centre
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Toronto, Ontario, Canada, M5G 1X5
- Mount Sinai Hospital
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Quebec
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Quebec City, Quebec, Canada, G1V 4G5
- Hôpital Laval
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre hospitalier universitaire de Sherbrooke (CHUS)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Critically ill adult patients > or equal to 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed influenza infection
- Requiring mechanical ventilation (invasive or non-invasive)
- Receiving antiviral therapy (any medication at any dose and for any intended duration) for < or equal to 72 hours
- Attending physician or intensivist must have a 'moderate' to 'high' index of suspicion for influenza
Exclusion Criteria:
- Age < 16 years
- Do not resuscitate or re-intubate order documented on chart or anticipated withdrawal of life support
- Weight < 40 kg
- Unable to receive or unlikely to absorb enteral study drug (e.g. incomplete or complete bowel obstruction, intestinal ischemia, infarction, short bowel syndrome)
Rosuvastatin specific exclusions:
- Already receiving a statin (Atorvastatin, Lovastatin, Simvastatin, Pravastatin, Rosuvastatin)
- Allergy or intolerance to statins
- Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or planned use of oral contraceptives or estrogen therapy during the ICU stay
- CK exceeds 10 times ULN or ALT exceeds 8 times the ULN
- Severe chronic liver disease (Child-Pugh Score 11-15)
- Previous enrollment in this trial
- Pregnancy or breast feeding
- At the time of enrollment, patients must not have received >72 hours of antiviral therapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Drug (Rosuvastatin) Crestor
The first dose of encapsulated study drug or placebo (day 1) will be administered within 4 hours of randomization as a loading dose of 40 mg.
The placebo will be identical in appearance to Rosuvastatin.
Thereafter, doses of 20 mg will be administered daily starting on the next calendar day at 10 pm daily (+/- 4 hours) as a maintenance dose from days 2 to 14.
If the patient is of Asian descent, is <18 years, or serum creatinine is greater than or equal to 248 μmol/L (2.8 mg/dL) dose adjustments will be made according to a dose adjustment algorithm.
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Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)
Autres noms:
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Comparateur placebo: Placebo
An identical appearing placebo will be administered to patients in the second study arm.
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identical appearing encapsulated placebo.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Proportion of eligible patients enrolled in the CHAT Pilot Trial.
Délai: anticipated 6 months (duration of pandemic)
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anticipated 6 months (duration of pandemic)
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Adherence to the medication regimen as outlined in the study protocol.
Délai: 14 day treatment course
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14 day treatment course
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Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial
Délai: 90 days
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90 days
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The number of study withdrawals due to administration of open label statins and consent withdrawals
Délai: anticipated 6 month study period
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anticipated 6 month study period
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: John C Marshall, MD, FRCPS, Unity Health Toronto
- Chercheur principal: Karen EA Burns, MD,FRCPC,MSc, Unity Health Toronto
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Infections par virus à ARN
- Maladies virales
- Infections des voies respiratoires
- Maladies des voies respiratoires
- Attributs de la maladie
- Infections à Orthomyxoviridae
- Infections
- Grippe humaine
- Maladie critique
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites
- Agents anticholestérolémiants
- Agents hypolipidémiants
- Agents de régulation des lipides
- Inhibiteurs de l'hydroxyméthylglutaryl-CoA réductase
- Rosuvastatine calcique
Autres numéros d'identification d'étude
- 001 CHAT 2009
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 .
Essais cliniques sur Rosuvastatin
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Ottawa Hospital Research InstituteInconnueThromboembolie veineuseCanada, Norvège