Phase
Condition
Lyme Disease
Rash
Treatment
Ceftriaxone (Rocephin®)
Dextrose 5% (D5W)
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 to 75 at the time of consent
Ability and willingness to sign informed consent
Available for the study period
Must have met the definition of a prior well-defined or probable Lyme diseaseinfection, AND meet the definition of PTLDS
Provide consent for release of medical history records from primary care physician,college or university, urgent care or emergency room visit
Have a level of fatigue that interferes with their ability to function in their job,schooling, or other social/personal activities (FSS score of 4 or higher)
Subjects will need to have been off of antibiotics (those standard antibiotics usedto target Lyme disease to include doxycycline, amoxicillin, cefuroxime,azithromycin, ceftriaxone or penicillin) for at least 6 weeks prior to studyenrollment and be willing to remain off of any outside antibiotics during theduration of the treatment component of the study.
Exclusion
Exclusion Criteria:
Female: pregnant or lactating
Women who intend to become pregnant during the treatment study period (approximately 45 days)
Patients with a diagnosis of Lyme disease based on only a positive Lyme IgMimmunoblot
A history of cephalosporin allergy or significant intolerance
Lyme related symptoms that have been present for greater than 10 years
Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1),hepatitis C, hepatitis B (assessed by HbsAg) virus. Note: Subjects who have well controlled HIV, who are on ART with a CD4 count greaterthan 200 will be allowed to participate.
Diagnosis with Bipolar Disorder or Schizophrenia, hospitalization in the past yearfor a mental health disorder, or any other psychiatric condition (to include anyfinding of increased suicide risk as identified by a rating of moderate or high riskon the CSSRS assessment), which in the opinion of the investigator prevents thesubject from participating in the study
Known concurrent rheumatologic or similar disease thought to interfere with studyparticipation or confound results at the discretion of the investigator. These mayinclude but are not limited to rheumatoid arthritis, systemic lupus erythematous,Sjogren's syndrome, scleroderma, psoriasis, fibromyalgia, chronic fatiguesyndrome/myalgic encephalomyelitis, or obstructive sleep apnea
Hives, shortness of breath, swelling of the lips or throat, or hospitalizationrelated to a previous treatment with a cephalosporin antibiotic, or severe allergicreaction to penicillins (e.g. anaphylaxis or severe rash with Stevens Johnsonsyndrome or similar)
Planned travel during the study period that would interfere with the ability tocomplete all study visits (this can be a temporary exclusion with plan to scheduleenrollment during a window of time during which they could attend their studyvisits)
Significant screening physical examination abnormalities or chronic medicalcondition that in the opinion of the investigator may impact subject safety
Participation (active or follow-up phase) or planned participation in anothervaccine, drug, or medical device in the 4 weeks prior to this trial, within 5times the elimination half-life, whichever is longer, or during the trial
Prior history of Clostridium difficile infection
Currently taking warfarin (Coumadin)
Unable to comply with study requirements
Clinician discretion
Study Design
Study Description
Connect with a study center
SUNY Upstate Medical University, Upstate Global Health Institute
East Syracuse, New York 13057
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.