Immune plasma for the treatment of severe influenza: an open-label, multicentre, phase 2 randomised study.

BACKGROUND: Influenza causes substantial morbidity and mortality despite available treatments. Anecdotal reports suggest that plasma with high antibody titres to influenza might be of benefit in the treatment of severe influenza. METHODS: In this randomised, open-label, multicentre, phase 2 trial, 29 academic medical centres in the USA assessed the safety and efficacy of anti-influenza plasma with haemagglutination inhibition antibody titres of 1:80 or more to the infecting strain. Hospitalised children and adults (including pregnant women) with severe influenza A or B (defined as the presence of hypoxia or tachypnoea) were randomly assigned to receive either two units (or paediatric equivalent) of anti-influenza plasma plus standard care, versus standard care alone, and were followed up for 28 days. The primary endpoint was time to normalisation of patients' respiratory status (respiratory rate of ≤20 breaths per min for adults or age-defined thresholds of 20-38 breaths per min for children) and a room air oxygen saturation of 93% or more. This study is registered with ClinicalTrials.gov, number NCT01052480. FINDINGS: Between Jan 13, 2011, and March 2, 2015, 113 participants were screened for eligibility and 98 were randomly assigned from 20 out of 29 participating sites. Of the participants with confirmed influenza (by PCR), 28 (67%) of 42 in the plasma plus standard care group normalised their respiratory status by day 28 compared with 24 (53%) of 45 participants on standard care alone (p=0·069). The hazard ratio (HR) comparing plasma plus standard care with standard care alone was 1·71 (95% CI 0·96-3·06). Six participants died, one (2%) from the plasma plus standard care group and five (10%) from the standard care group (HR 0·19 [95% CI 0·02-1·65], p=0·093). Participants in the plasma plus standard care group had non-significant reductions in days in hospital (median 6 days [IQR 4-16] vs 11 days [5-25], p=0·13) and days on mechanical ventilation (median 0 days [IQR 0-6] vs 3 days [0-14], p=0·14). Fewer plasma plus standard care participants had serious adverse events compared with standard care alone recipients (nine [20%] of 46 vs 20 [38%] of 52, p=0·041), the most frequent of which were acute respiratory distress syndrome (one [2%] vs two [4%] patients) and stroke (one [2%] vs two [4%] patients). INTERPRETATION: Although there was no significant effect of plasma treatment on the primary endpoint, the treatment seemed safe and well tolerated. A phase 3 randomised trial is now underway to further assess this intervention. FUNDING: National Institute of Allergy and Infectious Diseases, US National Institutes of Health.

Tularemia outbreak at a metropolitan airport, Texas.

A jackrabbit die-off near a metropolitan airport was observed by an airport contractor. Further investigation determined that this die-off was probably due to epizootic tularemia. Because of proximity to areas of heavy human traffic and fears of transmission of tularemia to humans, the local health district and department of emergency management organized a multiagency response involving local animal control, environmental health, public health, law enforcement, and airport personnel, in addition to state and federal agencies. The tularemia epizootic subsequently ended, and no cases of human tularemia occurred. In our after-action analysis, we identified several lessons learned: the importance of animal illness surveillance, which can serve as a warning for potential human illness and epidemic; the usefulness of pre-event planning, training, and exercises in facilitating a coordinated response; the usefulness of an effective communication system with the healthcare community; the importance of responders being familiar with Centers for Disease Control and Prevention (CDC) Category A bioterrorism agents when considering a rapid response; and the fact that attempts at environmental control may result in perturbations in animal populations with unintended consequences.

Top ten list of long-term care facility preparations for the upcoming influenza season.

A novel influenza A partly of virus of swine origin (2009 H1N1) emerged this spring, resulting in an influenza pandemic. This pandemic is anticipated to continue into the next influenza season. Given that the 2009 H1N1 and seasonal influenza A appear to be somewhat different in the human populations affected and that two influenza vaccines will be recommended this fall, those who manage long-term care facilities and treat patients in them will be faced with many uncertainties as they approach the 2009/10 influenza season. Ten specific suggestions are offered to those responsible for the care of patients in long-term care facilities regarding the upcoming influenza season. These practical suggestions are the clinical opinions of the authors and do not represent official recommendations of the American Geriatrics Society or any agency.