Roger and Nancy DeBlauw began last summer like any other, enjoying time on their farm in Crofton, Neb. But their world changed in late July 2005 when Roger became critically ill after contracting West Nile virus.
“It happened very suddenly,” said Nancy DeBlauw, Roger’s wife. “He didn’t have much energy, no appetite and he was running a fever. Within a few days he was in the hospital and moved to intensive care. No one was sure what was wrong.”
Since Roger DeBlauw was a kidney transplant recipient, he was transferred to The Nebraska Medical Center in Omaha where transplant specialists could monitor him. It’s also where his diagnosis of West Nile Virus was confirmed. Due to the severity of his condition, he was eligible to participate in a clinical trial of a potential treatment.
The trial is sponsored by the National Institutes of Health (NIH) and is being conducted regionally by UNMC. It’s ongoing through the end of 2006 and will be enrolling new patients throughout the summer and fall, prime seasons for West Nile virus in Nebraska and Iowa.
Alison Freifeld, M.D., an infectious diseases physician at UNMC who specializes in treating infections in patients who have received organ transplants or have cancer, is leading the portion of the study at UNMC. The university and its hospital partner, The Nebraska Medical Center, are among several sites across the nation and in Canada that are testing the medication, Omr-IgG-am. Thus far, no therapy has been proven effective in treating West Nile virus.
“We are hopeful that Omr-IgG-am will provide a better treatment for those infected with West Nile virus,” Dr. Freifeld said. “Right now, we need the physicians of patients who are exhibiting the most severe symptoms of West Nile virus such as myelitis or encephalitis to transfer those patients immediately to our hospital, so that they may participate in this clinical trial.”
Hospitalized patients with new onset of a neurologic abnormality, such as limb weakness or altered mental status, would be eligible to enroll in this study. In order to participate, the patient’s doctor would need to transfer them to The Nebraska Medical Center within 72 hours of a spinal tap that shows some evidence of a viral infection.
This study also is enrolling hospitalized adults with newly diagnosed West Nile fever and who are at high risk for going on to develop the severe neurologic symptoms of the disease, but do not yet have those symptoms. This group includes people who are over the age of 40 and/or have a compromised immune system from diabetes, cancer, a solid organ or stem cell transplant, or HIV infection. These patients may suffer from the most severe complications of West Nile virus infection and it is hoped that Omr-IgG-am may prevent those consequences.
Patients with these types of severe neurologic complications account for less than 1 percent of all cases of the disease. In 2005 in Nebraska, 188 cases of West Nile virus were documented, including five deaths, compared with 53 cases and no deaths in 2004. West Nile virus is transmitted by mosquitoes.
The NIH National Institute of Allergy and Infectious Diseases is supporting the trial.
Omr-IgG-am is expected to be effective because it contains high levels of antibodies against West Nile virus. These high antibody levels are present in the product because it is derived from donors living in Israel, where the virus is common in the environment and people are highly exposed to it.
During the trial, three of every five patients will receive the Omr-IgG-am, while 20 percent will receive another treatment and 20 percent a placebo. “It is important to do this type of randomization in order to know whether the new drug is really better and safer than other similar drugs, or no drug at all,” Dr. Freifeld said.
Nancy and Roger DeBlauw don’t know what he received – that information won’t be shared with them until the clinical trial is complete. They do know their encounter with West Nile virus was much worse than they could’ve imagined.
“Roger always wore a mask when he was in the shop working in case there was mold or something like that in the air, but we never thought about West Nile virus,” his wife said. “We just didn’t think it was in our area. All it took was a little mosquito bite.”
Roger still suffers from vision loss and uses a wheelchair and a walker to get around. He’s making progress as he works toward using a cane. However, doctors believe these health problems are more likely due to his diabetes than West Nile.
Health professionals who think their patients may have West Nile virus and have questions about whether a patient would be eligible should contact research nurse coordinators Kimberly Bargenquast or Penny Hardiman at 402-559-8650 as soon as possible.