Lyme Arthritis Treatment with NSAIDs in Pediatric Patients – Phase III

Protocol Description

The purpose of the research study is to evaluate whether giving certain medications daily can help decrease the amount of time that a child has Lyme arthritis joint swelling and pain. Lyme arthritis results from Lyme disease, which is caused by an infection after a tick bite. Although Lyme arthritis usually resolves with antibiotic treatment for most patients, some continue to have joint swelling. Researchers believe that prescribing a nonsteroidal anti-inflammatory drug (NSAID) on a scheduled basis at the time of diagnosis of Lyme arthritis may prevent excessive inflammation and decrease the number of patients with persistant Lyme arthritis, or at least decrease the duration of Lyme arthritis symptoms.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, pediatric patients treated by the Emergency Department for joint swelling due to arthritis, who are also being tested for Lyme disease, will be invited to participate in the research study.
Boys and Girls: Ages 3 through 17

Requirements

In addition to being prescribed an antibiotic for treatment of Lyme disease, participants will be randomly assigned to take either an analgesic pain medicine (acetaminophen), an NSAID (naproxen), a sequence of both, or neither for up to 28 days. Using a text survey, the research team will follow up with participants 8 times in the first month, then monthly until symptoms are completely gone.
Visits: 1, the initial Emergency Department visit
Duration: About 60 days

Status: Open to Enrollment

Additional Information

Study Description at National Institutes of Health
Lyme Disease
Emergency Medicine Research

Primary Investigator

Desiree Noel Wagner Neville, MD

Contact Information

For more information about the study or enrollment, please contact:
Research Coordinator
412-864-8380