This flu season, researchers at Johns Hopkins University are using the emergency room setting for clinical trials on patients who present with acute respiratory illness, according to a Baltimore Sun article published online Nov. 20.
Author Meredith Cohn wrote in the article that “doctors are poised to launch a trial run at Hopkins during the coming flu season — and using already approved antiviral drugs such as Tamiflu — to show volunteers can quickly and properly be pooled in such environments.”
Dr. Richard Rothman, a professor of emergency medicine in the Johns Hopkins University School of Medicine and the study’s co-leader stated in the article, “Normally you do trials in doctors’ offices or inpatient wards with 100 or 200 sites often needed over several seasons because each site may only enroll one to three people. Here in the emergency department, a lot of people come in sick. That creates an opportunity.”
The federally funded Influenza Therapeutic Pilot Study involves following patients for two weeks during which time they will receive daily calls from researchers who will ask them about their symptoms, according to a related video by the Baltimore Sun.
The article stated that since the emergency room is flooded with patients with flu each fall and winter season, it will be easy to enroll many patients, and therefore shave years off of the clinical trial period. The method potentially could be replicated in other EDs.
Rapid lab testing to confirm influenza allows the researchers to enroll many sick patients in the trial over a 12-month period, according to Clinicaltrials.gov. Patients complete a treatment with IV (peramivir) or oral medication (oseltamivir). They are then followed up, and their level of functioning is assessed by the Karnofsky Performance Status Scale, according to the trial description on Clinicaltrials.gov.
Patients must meet CDC criteria for antiviral treatment, be 18 years or older, provide written consent, and have symptoms of acute respiratory illness for fewer than four days, according to the study.
“For the purpose of this study, acute respiratory illness is defined as presence of any of the following symptoms: new or increased cough, new or increased shortness of breath, change in sputum production (for adults 65 years or older), sinus pain, nasal congestion, rhinorrhea, sore throat, subjective fever reported at time of triage or documented fever (defined here as ≥ 38 degrees Celsius),” the study stated.
According to the U.S. Food and Drug Administration, clinical trials take years to complete and involve a four-phase process that includes safety and dosage, efficacy and side effects, and monitoring of adverse reactions.
The CDC stated on its website that “during the 2014-2015 influenza season, 98.4% of the 2009 H1N1 viruses tested for surveillance were susceptible to oseltamivir and peramivir, and 100% of the 2009 H1N1 viruses tested were susceptible to zanamivir.”
During the previous flu season, 98.2% of flu viruses were susceptible to oseltamivir and 100% of viruses were susceptible to zanamivir, according to the CDC.