Trial reportIntensive care medicine2012
Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic.
Trial report in Intensive care medicine, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01014364 (Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Pooled it
- Factors Associated with Trust and Likelihood of Participation in Pandemic-Related Clinical Trials Among Blacks in the U.S. Deep South.Journal of racial and ethnic health disparities · 2026Article
- Corticosteroids for severe influenza pneumonia: a persistent evidence gap.Intensive care medicine · 2026Article
- Approval delays in multi-country COVID-19 trials: the case of COPCOV and the risk of therapeutic inertia.Trials · 2025Article
- Variations in Administrative Approvals During the COVID-19 Pandemic at Participating Sites in the Society of Critical Care Medicine Discovery Network Viral Infection and Respiratory Illness Universal Study: COVID-19 Registry: A Cross-Sectional Study.Critical care explorations · 2022Article
- Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review.BMC medicine · 2020Article
- Impact of corticosteroid treatment on clinical outcomes of influenza-associated ARDS: a nationwide multicenter study.Annals of intensive care · 2020Article
- Clinician-researcher's perspectives on clinical research during the COVID19 pandemic.PloS one · 2020Article
- Influenza virus-related critical illness: prevention, diagnosis, treatment.Critical care (London, England) · 2019Review
- Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenzaa.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
- Influenza and Viral Pneumonia.Clinics in chest medicine · 2018Review
- Article
- Fatal influenza A(H1N1)pdm09 encephalopathy in immunocompetent man.Emerging infectious diseases · 2013Article
- Year in review in Intensive Care Medicine 2012. II: Pneumonia and infection, sepsis, coagulation, hemodynamics, cardiovascular and microcirculation, critical care organization, imaging, ethics and legal issues.Intensive care medicine · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo analyze the hurdles in implementing a randomized trial of corticosteroids for severe 2009 H1N1 influenza infections.
methodsThis was an investigator-led, multicenter, randomized, placebo-controlled, double-blind trial of corticosteroids in ICU patients with 2009 H1N1 influenza pneumonia requiring mechanical ventilation. The feasibility of and hurdles in designing and initiating a phase III trial in a short-lived pandemic crisis were analyzed. The regulatory agency and ethics committee approved the study's scientific, financial, and ethical aspects within 4 weeks. Hydrocortisone and placebo were prepared centrally and shipped to participating hospitals within 6 weeks. The inclusion period started on November 9, 2009.
resultsFrom August 1, 2009 to March 8, 2010, only 205/224 ICU patients with H1N1 infections required mechanical ventilation. The peak of the wave was missed by 2-3 weeks and only 26 patients were randomized. The two main reasons for non-inclusion were patients' admission before the beginning of the trial and ICU personnel overwhelmed by clinical duties. Parallel rather than sequential regulatory and ethics approval, and preparation and masking of study drugs by local pharmacists would have allowed the study to start 1 month earlier and before the peak of the "flu" wave. A dedicated research team in each participating center would have increased the ratio of screened to randomized patients.
conclusionThis report highlights the main hurdles in implementing a randomized trial for a pandemic critical illness and proposes solutions for future trials.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.