Symptomatic Management of Lyme Arthritis
Megadott ok: Study with overlapping patient population
A legfontosabb adatok
- Hol
- Pittsburgh (Egyesült Államok)A helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Children's Hospital of Pittsburgh of UPMCPittsburgh, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Desiree Neville, MD
- Azonosító
- NCT04038346
- A regiszteradat frissítve
- 2025. november 17.
- Eredeti leírás
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing.A teljes eredeti leírásKevesebb
Lyme arthritis resolves with appropriate antimicrobial treatment in a majority of patients, but 10-20% of patients develop antibiotic-refractory Lyme arthritis with prolonged arthritis symptoms and treatment courses. Excessive up-regulation of the inflammatory process has been shown in patients with antibiotic-refractory Lyme arthritis. The over-expressed pro-inflammatory cell mediators are downstream of NSAID inhibition, which would suggest initial inflammatory inhibition may be beneficial in these patients. While NSAIDs are known to reduce pro-inflammatory cell mediators early in the course of inflammation, research has shown that there are other cytokines that play a role in the healing after inflammation that are also inhibited by NSAIDs, and that NSAID use can delay healing.
It is not known if scheduled NSAID therapy will reduce, increase, or have no effect on the occurrence of refractory Lyme arthritis cases. The hypothesis of the study is that prescribing scheduled NSAIDs at the time of diagnosis of Lyme arthritis can prevent the development of the excessive inflammatory phase and decrease the number of patients with antibiotic-refractory Lyme arthritis, or at least decrease the duration of persistent Lyme arthritis symptoms.
The pilot study design randomizes patients to scheduled NSAIDs, scheduled acetaminophen, or scheduled NSAIDs x 1 week than acetaminophen. Primary outcomes are duration of arthritis symptoms, number of refractory cases, side effects and compliance.
Bevonási feltételek: Arthritis; Undergoing Lyme disease testing (Lyme test positive).
Kizáró feltételek: Patients will be secondarily withdrawn from analysis and instructed to stop study medication if their Lyme test is negative; Underlying diagnosis of rheumatoid or recurrent arthritis Already on scheduled NSAIDs; Anything that restricts the prescription of naproxen or acetaminophen:; Hypersensitivity to naproxen (for example: anaphylactic reactions, serious skin reactions) or any component of the formulation; history of aspirin induced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, underlying kidney or liver impairment; Hypersensitivity to acetaminophen or any component of the formulation; severe liver impairment or severe active liver disease; Already taking daily NSAIDs (naproxen or ibuprofen) or daily acetaminophen.