Collaborative H1N1 Adjuvant Treatment Pilot Trial (CHAT)
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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)
Andre navn:
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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Proportion of eligible patients enrolled in the CHAT Pilot Trial.
Tidsramme: anticipated 6 months (duration of pandemic)
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anticipated 6 months (duration of pandemic)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Adherence to the medication regimen as outlined in the study protocol.
Tidsramme: 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
Tidsramme: 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
Tidsramme: anticipated 6 month study period
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anticipated 6 month study period
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: John C Marshall, MD, FRCPS, Unity Health Toronto
- Hovedetterforsker: Karen EA Burns, MD,FRCPC,MSc, Unity Health Toronto
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- RNA-virusinfeksjoner
- Virussykdommer
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Sykdomsattributter
- Orthomyxoviridae-infeksjoner
- Infeksjoner
- Influensa, menneske
- Kritisk sykdom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antimetabolitter
- Antikolesteremiske midler
- Hypolipidemiske midler
- Lipidregulerende midler
- Hydroksymetylglutaryl-CoA-reduktasehemmere
- Rosuvastatin kalsium
Andre studie-ID-numre
- 001 CHAT 2009
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