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Clinical trial to begin amid looming valley fever epidemic

Oct 15, 2016
Press Release

Clinical trial to begin amid looming valley fever epidemic


Harold Pierce




On the eve of what could be the worst year for valley fever cases since the so-called Great Epidemic of the early 1990s, national healthcare leaders announced Thursday the start of a clinical trial to gain more insight into the effectiveness of early treatment.


The trial, involving the National Institutes of Health, the Centers for Disease Control and Prevention, Duke University and Kern Medical Center, is the first major research study to come out of a national valley fever symposium Congressman Kevin McCarthy hosted here in 2013.


“We’ve never had a trial to know the best way to treat somebody when they had valley fever," McCarthy, R-Bakersfield, said during a press conference at KMC announcing the study's kickoff. "This trial could not come soon enough."


The study will run over 72 months and require 1,000 adults exhibiting signs of pneumonia to participate. Half of those individuals will be given Fluconazole, a medication used to treat other fungal ailments but commonly given to valley fever patients without careful study of its effectiveness. The remainder will receive placebos.


The most severe cases of valley fever stem from lack of early treatment, said Dennis Dixon, chief of the NIH bacteriology and mycology branch. Valley fever is frequently misdiagnosed, he added. Scores of survivors say their valley fever was initially diagnosed as the flu, then pneumonia, with weeks passing before a doctor discovered it’s something more serious.


McCarthy and healthcare leaders urged those experiencing signs of valley fever to have their doctors sign up with KMC for the FLEET trial, short for Fluconazole as Early Empiric Treatment.


“If you participate, not only could you be treated better, but we could identify it sooner, minimize it," McCarthy said. "Think what you’re going to do for the future generations here. For your grandchildren, for your children, for the future opportunities."


Valley fever, which infects thousands of people every year throughout the southwest United States, has long received little national attention and funding. McCarthy is largely credited with securing the $5 million for the clinical trial, a significant victory as more prominent international diseases, like the Zika virus, tend to nab more funding and attention.


“What (they’ve) done is make a very small concentrated area visible on the national stage,” state Sen. Jean Fuller, R-Bakersfield, said Thursday, praising McCarthy and national healthcare leaders. “So if we fail, if we are unable to enroll enough of all kinds of people who are suffering from this in the trial, we will fall off that national stage."


Raising awareness of the disease, which is contracted by breathing cocci fungal spores swept into the air, has been a challenge even in endemic regions. Those speaking Thursday said they will raise the awareness needed to enroll trial participants by flooding other San Joaquin Valley hospitals, physicians' offices and clinics with materials promoting participation.


“Just by conducting the trial, we have the ability to increase that awareness,” Dixon said.


It’s a coincidence that the trial kick-off, which has been years in the making, is occurring during what experts predict could be the worst year for valley fever since the Great Epidemic of the early 1990s.


That alone should drive trial enrollment, experts said. 


In as long as health officials have been tracking valley fever in Kern County, no year has seen as many infections, or led to as many deaths, as 1992. Roughly 3,342 people were diagnosed with the disease, 25 of whom died. This year, one has died and more than 890 cases had been reported to the state public health data system through June.


Royce Johnson, a Kern Medical Center doctor who has studied valley fever for years, likened the looming epidemic to the one Kern County saw in 1992.


“From our perspective, this has already been the worst year. We’ve already had a death, have another in ICU — that could be a year’s worth right there,” Johnson said. "So by accident, we designed this study to start at a very appropriate moment in history."