Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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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
- Hopital Laval
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre hospitalier universitaire de Sherbrooke (CHUS)
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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)
Andere namen:
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Placebo-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Proportion of eligible patients enrolled in the CHAT Pilot Trial.
Tijdsspanne: anticipated 6 months (duration of pandemic)
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anticipated 6 months (duration of pandemic)
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Adherence to the medication regimen as outlined in the study protocol.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: anticipated 6 month study period
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anticipated 6 month study period
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: John C Marshall, MD, FRCPS, Unity Health Toronto
- Hoofdonderzoeker: Karen EA Burns, MD,FRCPC,MSc, Unity Health Toronto
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- RNA-virusinfecties
- Virusziekten
- Luchtweginfecties
- Ziekten van de luchtwegen
- Ziekte attributen
- Orthomyxoviridae-infecties
- Infecties
- Influenza, mens
- Kritieke ziekte
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten
- Middelen tegen cholesterol
- Hypolipidemische middelen
- Vetregulerende middelen
- Hydroxymethylglutaryl-CoA-reductaseremmers
- Rosuvastatine Calcium
Andere studie-ID-nummers
- 001 CHAT 2009
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