H1N1 InfluenzaPhase 2CHAT PilotNCT01798602
Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
A Phase 2 study of H1N1 Influenza, run by Canadian Critical Care Trials Group at 1 site in Canada.
Trial summary
The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- H1N1 Influenza
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2009to Aug 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 > 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
- Requiring mechanical ventilation (invasive or non-invasive)
- Receiving antiviral therapy (any medication at any dose and for any intended duration) for < 72 hours
- Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1
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) (see Appendix 6)
- Previous enrolment in this trial
- Pregnancy or breast feeding
- At the time of enrolment, patients must not have received >72 hours of antiviral therapy
Trial locations and contacts
1 site in 1 country.
About this study
The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.
Read the detailed description
This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza
- Conditions
- H1N1 Influenza
- Being tested
- Rosuvastatin or identical placebo, Placebo
- Keywords
- H1N1, Rosuvastatin
- Medical subject headings
- Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin or identical placeboDrug
Also called Crestor, Placebo
Tablet crushed for administration via feeding tube
PlaceboDrug
Identical placebo for rosuvastatin
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug
Both are crushed for administration Receives: Drug: Rosuvastatin or identical placebo |
| Placebo | Placebo comparator | Identical drug vehicle with no active agent Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients enrolled in the CHAT study
This was a pilot study whose primary goal was to evaluate the feasibility of patient recruitment during an emerging pandemic
Measured: Over 6 month period or during H1N1 pandemic
Secondary outcomes (4)
Adherence to the medication administration regimen as outlined in the study protocol.
Measured: 2 weeks
Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.
Measured: 6 months
The number of study withdrawals due to administration of open label statins and withdrawals of consent.
Measured: Up to 28 days or until hospital discharge
Recruitment rates by consent model.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startDec 2009
- Primary completionMay 2010
- Study completionAug 2010
Why it stopped: H1N1 pandemic concluded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for H1N1 InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Critical Care Trials Group
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation, Public Health Agency of Canada (PHAC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798602
- Sponsor's protocol ID
- CCCTG
- Acronym
- CHAT Pilot
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2013
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Burns KE, Chant C, Smith O, Cuthbertson B, Fowler R, Cook DJ, Kruger P, Webb S, Alhashemi J, Dominguez-Cherit G, Zala C, Rubenfeld GD, Marshall JC. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial. Trials. 2011 Mar 9;12:70. doi: 10.1186/1745-6215-12-70.
PubMed 21388549
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative H1N1 Adjuvant Treatment (CHAT) Pilot Trial
- ClinicalTrials.gov ID
- NCT01798602
- Acronym / sponsor ID
- CHAT Pilot / CCCTG
- Conditions
- H1N1 Influenza
- Keywords
- H1N1, Rosuvastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: H1N1 pandemic concluded
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Canadian Critical Care Trials GroupUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Physicians' Services Incorporated Foundation, Public Health Agency of Canada (PHAC)
- Study start
- Dec 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The CHAT Pilot Trial is designed to compare rosuvastatin against placebo in patients with suspected H1N1. The pilot study will assess the feasibility of our clinical protocols, and study procedures.
Detailed description
This trial is a pilot study to assess the feasibility and acceptability of a double blind randomized controlled trial (RCT) evaluating the efficacy of rosuvastatin as adjuvant therapy for H1N1 influenza
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin or identical placeboRosuvastatin 40 mg via nasogastric tube then 20 mg po or via nasogastric tube daily for 14 days or until hospital discharge Placebo is identical capsule with no active drug Both are crushed for administration |
| Placebo | Placebo comparator | Drug: PlaceboIdentical drug vehicle with no active agent |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Critically ill adult patients > 16 years of age admitted to an adult ICU for any reason with suspected, probable or confirmed novel swine origin influenza A/H1N1 infection
- Requiring mechanical ventilation (invasive or non-invasive)
- Receiving antiviral therapy (any medication at any dose and for any intended duration) for < 72 hours
- Clinicians must have a 'moderate', 'high' or 'moderate to high' index of suspicion for H1N1
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin or identical placeboAlso: Crestor, PlaceboTablet crushed for administration via feeding tube | Drug | Rosuvastatin |
| PlaceboIdentical placebo for rosuvastatin | Drug | Placebo |
Primary outcome
Proportion of eligible patients enrolled in the CHAT study
Time frame: Over 6 month period or during H1N1 pandemic
This was a pilot study whose primary goal was to evaluate the feasibility of patient recruitment during an emerging pandemic
4 secondary outcomes
Adherence to the medication administration regimen as outlined in the study protocol.
Time frame: 2 weeks
Proportion of completed primary and secondary endpoints for the planned full CHAT trial that are collected.
Time frame: 6 months
The number of study withdrawals due to administration of open label statins and withdrawals of consent.
Time frame: Up to 28 days or until hospital discharge
Recruitment rates by consent model.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: H1N1 pandemic concluded). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2013.
- Background: PubMed 21388549Burns KE, Chant C, Smith O, Cuthbertson B, Fowler R, Cook DJ, Kruger P, Webb S, Alhashemi J, Dominguez-Cherit G, Zala C, Rubenfeld GD, Marshall JC. A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial. Trials. 2011 Mar 9;12:70. doi: 10.1186/1745-6215-12-70.
- International Forum for Acute Care Trialists WebsiteLink provided by the sponsor.
- Canadian Critical Care Trials GroupLink provided by the sponsor.
Related trials for H1N1 Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of H1N1 Influenza, run by Canadian Critical Care Trials Group at 1 site 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 26 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 1 site 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). 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 study (time frame: Over 6 month period or during H1N1 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 NCT01798602, which also lists 1 linked publication.
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 26 Feb 2013.