Study and Treatment of Post Lyme Disease (STOP-LD)
Collecte de données
Maladies vectorielles+6
+ Infections bactériennes
+ Infections bactériennes et mycoses
Étude thérapeutique
Résumé
You will be assigned randomly (like tossing a coin) to receive either antibiotics or a placebo (sugar pill). Neither you nor your doctor will know which you are receiving. You will learn to give yourself the injection, and you will remain on your study drug for 28 days. A home health care nurse will visit you twice a week to check the injection site, and at weeks 1 and 3 the nurse will draw blood for laboratory tests. At months 1 and 6, you will be examined to see if you have fewer chronic fatigue symptoms after the antibiotics. This will include a fatigue questionnaire, a test of your mental processing speed, and a test of your cerebrospinal fluid.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.55 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: You may be eligible for this study if you: * Are between 18 and 65 years of age. * Are a resident of Long Island or greater NY metropolitan area. * Are fluent in English. * Have a history of Lyme Disease. * Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study. * Have severe fatigue. * Are not pregnant or planning to be pregnant. Exclusion Criteria: You will not be eligible for this study if you: * Have or have had major medical, neurologic, or psychiatric disorder. * Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease. * Have had Fibromyalgia Syndrome. * Have a history of sleep apnea, narcolepsy, or other serious sleep disorder. * Have a learning disability. * Have had head trauma requiring hospitalization. * Have symptomatic gallbladder disease. * Are anemic. * Abuse alcohol or illicit drugs. * Have been treated with another antimicrobial agent for Lyme Disease within 6 months of study. * Need to be receiving systemic steroid therapy during drug administration and follow-up. * Have used benzodiazepines within 1 month of study entry. * Are allergic to Beta lactams (a class of antibiotics).
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site