The Lyme Disease Network
|Title:||Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trials of the Safety and Efficacy of Ceftriaxone and Doxycycline in the Treatment of Patients with Seropositive and Seronegative Chronic LD|
|Conference:||10th Annual International Scientific Conference on Lyme Disease & Other Tick-Borne Disorders, National Institutes of Health, Bethesda, MD April 28-30, 1997|
|Presenter:||Mark Klempner, M.D. |
Tufts New England Medical Center
A description of the NIH supported clinical protocols for the characterization and treatment of patients with Chronic Lyme Disease (CLD) will be presented.
The objectives of these studies are to determine whether:
1. intensive antibiotic treatment benefits seropositive and seronegative patients with CLD,
2. evidence of persistent infection with Bb can be found in patients with CLD,
3. evidence of coinfection with other microorganisms can be found in patients with CLD,
4. specific clinical or laboratory parameters improve in patients who receive antibiotic therapy compared to patients who receive placebo, and
5. specific parameters are predictive of a response to therapy should it be observed.
These studies are Phase III, randomized, double-blinded, placebo-controlled, multicenter trials (two centers). 260 patients will be enrolled in the studies and randomized to receive either antibiotic therapy or placebo in a 1:1 ratio; antibiotics and placebo will be administered both intravenously and orally. The antibiotic regimen will be intravenous ceftriaxone 2 gms/day for 30 days followed by oral doxycycline 200mg/day for 60 days. Placebos identical in appearance to the intravenous and oral antibiotics will be administered by the same routes and for the same duration to patients randomized to the placebo group. Initial and serial analyses during treatment will include PCR of plasma and CSF for borrelia and other organism DNA, borrelia urinary antigen, and serum antibodies to organisms transmitted by Ixodes ticks. Primary outcome analysis for the efficacy of antibiotic therapy will be determined by improvement in the patient's health related quality of life as measured by the SF-36 Health Survey. Other assessments will include changes in pain and cognition using scales from the Medical Outcomes Study, the fibromyalgia impact questionnaire, neuropsychological tests, and nerve conduction studies for patients with neuropathic pain.
Unique ID: 97LDF032
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