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Critically IllPhase 2CHATNCT01033955

Collaborative H1N1 Adjuvant Treatment Pilot Trial

A Phase 2 study testing Rosuvastatin in people with Critically Ill and H1N1/Influenza Infection, run by Canadian Critical Care Trials Group at 9 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study Design: A, multinational, double blind, placebo-controlled pilot RCT involving 80 patients in the general ICUs of 30 centres. Most patients will be recruited from within Canada; however cases will be recruited from international sites. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Critically Ill, H1N1/Influenza Infection
What is being tested?
Rosuvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8 participants
Where
9 sitesCanada
Study dates
Jan 2010to Jul 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Canada9 sites

  • St. Joseph's Healthcare

    Hamilton, Ontario, L8N 4A6

  • Hopital Laval

    Québec, Quebec, G1V 4G5

  • Centre hospitalier universitaire de Sherbrooke (CHUS)

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

  • Health Sciences Centre

    Winnipeg, Manitoba, R3B 0Z3

Other trials in Canada

About this study

Official title: Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial

Study Design: A, multinational, double blind, placebo-controlled pilot RCT involving 80 patients in the general ICUs of 30 centres. Most patients will be recruited from within Canada; however cases will be recruited from international sites. This study will be conducted under the auspices of the Canadian Critical Care Trials Group (CCCTG) and the International Forum for Acute Care Trialists (InFACT).

Read the detailed description

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.

Being tested
Rosuvastatin, Placebo
Keywords
critical care, H1N1/influenza infection, respiration, ventilation, artificial, critically ill patients, invasive mechanical ventilation, H1N1/influenza infection (suspected, probable or confirmed)
Medical subject headings
Critical Illness, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RosuvastatinDrug

    Also called Crestor

    Loading dose: 40 mg (day 1) Maintenance dose: 20 mg (days 2-14)

  • PlaceboDrug

    identical appearing encapsulated placebo.

Study groups in NCT01033955
Study groupRoleWhat they receive
Drug (Rosuvastatin) CrestorExperimentalThe 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.
Receives: Drug: Rosuvastatin
PlaceboPlacebo comparatorAn identical appearing placebo will be administered to patients in the second study arm.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of eligible patients enrolled in the CHAT Pilot Trial.

    Measured: anticipated 6 months (duration of pandemic)

Secondary outcomes (3)

  1. Adherence to the medication regimen as outlined in the study protocol.

    Measured: 14 day treatment course

  2. Proportion of completed primary and secondary endpoints collected for the planned full CHAT trial

    Measured: 90 days

  3. The number of study withdrawals due to administration of open label statins and consent withdrawals

    Measured: anticipated 6 month study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionMay 2010
  4. Study completionJul 2010

Why it stopped: H1N1 pandemic concluded in early 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01033955
Sponsor's protocol ID
001 CHAT 2009
Acronym
CHAT
Status last verified
Feb 2013
First submitted
16 Dec 2009
Last updated
21 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rosuvastatin in people with Critically Ill and H1N1/Influenza Infection, run by Canadian Critical Care Trials Group at 9 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: H1N1 pandemic concluded in early 2010). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of eligible patients enrolled in the CHAT Pilot Trial. (time frame: anticipated 6 months (duration of pandemic)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01033955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2013.

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