Pneumonia, ViralPhase 3CORTIFLUNCT01014364
Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu
A Phase 3 study testing hydrocortisone and isotonic saline in people with Pneumonia, Viral and Influenza in Humans, run by University of Versailles at 1 site in France.
Trial summary
The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Pneumonia, Viral, Influenza in Humans
- What is being tested?
- hydrocortisone and isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Dec 2011
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age above 15 years old
- admitted to intensive care unit
- proven or strong suspicion of H1N1 Influenza infection
- diffuse pneumonia (for less than 96 hours)
- need for non invasive or invasive mechanical ventilation
Who cannot join
- pregnancy
- an age of 15 or less
- rapidly fatal underlying disease with a life expectancy of one month or less
- more than 3 organ dysfunction upon admission
- previous treatment with corticosteroids (ie prednisone 30 mg per day or more, or equivalent, for at least one month)
- formal indication for corticosteroids (eg Addison disease, status asthmaticus)
Show all 10Show fewer
- already on corticosteroids for 2 days or more in the management of the current episode
- acute lung injury not related to viral pneumonia
- presence of H1N1 related acute myocarditis or encephalitis
- receiving antiviral treatment for more than 5 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
- Conditions
- Pneumonia, Viral, Influenza in Humans
- Being tested
- hydrocortisone, isotonic saline
- Keywords
- Acute lung injury, Acute respiratory distress syndrome, corticosteroids, inflammation
- Medical subject headings
- Pneumonia, Viral, Influenza, Human, Acute Lung Injury, Respiratory Distress Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
Also called hydrocortisone acetate
50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
isotonic salineDrug
Also called normal saline
intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
| Study group | Role | What they receive |
|---|---|---|
| Corticosteroids | Experimental | Hydrocortisone Receives: Drug: hydrocortisone |
| Control | Placebo comparator | isotonic saline Receives: Drug: isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
in hospital all cause morality
Measured: hospital discharge up to 90 days
Secondary outcomes (8)
28 day mortality
Measured: 28 day
90 day all cause mortality
Measured: 90 day
6 month all cause mortality
Measured: 180 days
mechanical ventilation free days
Measured: hospital discharge up to 90 days
intensive care unit free days
Measured: hospital discharge up to 90 days
proportion of patients with secondary infections
Measured: hospital discharge up to 90 days
proportion of patients who require ECMO
Measured: hospital discharge up to 90 days
respiratory function and health status
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionDec 2011
Why it stopped: the H1N1 pandemic is now over, and fewer cases than expected were observed
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 Pneumonia, ViralStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Versailles
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Principal investigator, Djillali Annane, University of Versailles
- Investigators
- Djillali Annane, MD,PhD, Study chair, AP--HP and University of Versailles SQYChristian Brun Buisson, MD, Principal investigator, AP-HP and Paris XII UniversityCharles Mayaud, Principal investigator, AP-HP and University of Paris VIIBernard Régnier, Principal investigator, AP-HP and Paris VII UniversityChristian Perronne, Principal investigator, AP-HP and University of Versailles SQY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014364
- Sponsor's protocol ID
- PCR09006
- Acronym
- CORTIFLU
- Status last verified
- Dec 2014
- First submitted
- 16 Nov 2009
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Annane D, Antona M, Lehmann B, Kedzia C, Chevret S; CORTIFLU Investigators; CRICs; AZUREA; REVA/SRLF networks. Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic. Intensive Care Med. 2012 Jan;38(1):29-39. doi: 10.1007/s00134-011-2409-8. Epub 2011 Nov 26.
PubMed 22120766
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
- ClinicalTrials.gov ID
- NCT01014364
- Acronym / sponsor ID
- CORTIFLU / PCR09006
- Conditions
- Pneumonia, Viral, Influenza in Humans
- Keywords
- Acute lung injury, Acute respiratory distress syndrome, corticosteroids, inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the H1N1 pandemic is now over, and fewer cases than expected were observed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of VersaillesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Nov 2009 (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 H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corticosteroids | Experimental | Drug: hydrocortisoneHydrocortisone |
| Control | Placebo comparator | Drug: isotonic salineisotonic saline |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age above 15 years old
- admitted to intensive care unit
- proven or strong suspicion of H1N1 Influenza infection
- diffuse pneumonia (for less than 96 hours)
- need for non invasive or invasive mechanical ventilation
Key exclusion criteria (10 listed)
- pregnancy
- an age of 15 or less
- rapidly fatal underlying disease with a life expectancy of one month or less
- more than 3 organ dysfunction upon admission
- previous treatment with corticosteroids (ie prednisone 30 mg per day or more, or equivalent, for at least one month)
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 |
|---|---|---|
| hydrocortisoneAlso: hydrocortisone acetate50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week | Drug | Corticosteroids |
| isotonic salineAlso: normal salineintravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week | Drug | Control |
Primary outcome
in hospital all cause morality
Time frame: hospital discharge up to 90 days
8 secondary outcomes
28 day mortality
Time frame: 28 day
90 day all cause mortality
Time frame: 90 day
6 month all cause mortality
Time frame: 180 days
mechanical ventilation free days
Time frame: hospital discharge up to 90 days
intensive care unit free days
Time frame: hospital discharge up to 90 days
proportion of patients with secondary infections
Time frame: hospital discharge up to 90 days
proportion of patients who require ECMO
Time frame: hospital discharge up to 90 days
respiratory function and health status
Time frame: 180 days
Results and safety
The study was stopped early (reason given: the H1N1 pandemic is now over, and fewer cases than expected were observed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Results publication: PubMed 22120766Annane D, Antona M, Lehmann B, Kedzia C, Chevret S; CORTIFLU Investigators; CRICs; AZUREA; REVA/SRLF networks. Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic. Intensive Care Med. 2012 Jan;38(1):29-39. doi: 10.1007/s00134-011-2409-8. Epub 2011 Nov 26.
Related trials for Pneumonia, Viral
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Djillali Annane, MD,PhD study chair
AP--HP and University of Versailles SQY
Christian Brun Buisson, MD principal investigator
AP-HP and Paris XII University
Charles Mayaud principal investigator
AP-HP and University of Paris VII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hydrocortisone and isotonic saline in people with Pneumonia, Viral and Influenza in Humans, run by University of Versailles at 1 site in France.
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 5 inclusion and 10 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 18 Dec 2014. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: the H1N1 pandemic is now over, and fewer cases than expected were observed). 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?
in hospital all cause morality (time frame: hospital discharge up to 90 days). 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 NCT01014364, 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 18 Dec 2014.