TABLE 1.
Inclusion and exclusion criteria for enrollment in the LDBa
| Enrollment type | Inclusion criteria | Exclusion criteria |
|---|---|---|
| Type 1 | Presents in region of endemicity | Immunocompromisedb |
| Physician identification/assessment | Antibiotics initiated >48 hc | |
| EM lesions of >5 cm (type 1A) or EM/annular expanding lesions of ≤5 cm (type 1B) | <10 yr of age | |
| Tick bite reaction without EM or expanding annular lesion | ||
| Type 2 | Presents in region of endemicity | Immunocompromised |
| Physician identification/assessment | History of CFS, rheumatologic disease, MS | |
| At least one of the following: headache, fatigue, fever, chills, or joint or muscular pain | Antibiotics initiated >48 hc <10 yr of age | |
| Suspected tick exposure/tick bite | ||
| EC | Residence in area where LD is endemic | Immunocompromised |
| History of LD or other TBI | ||
| <10 yr of age |
a
Abbreviations: LD, Lyme disease; EM, erythema migrans; CFS, chronic fatigue syndrome; MS, multiple sclerosis; EC, controls from areas of endemicity; TBI, tick-borne infection.
b
Immunocompromised individuals, including individuals with HIV infection and individuals undergoing chemotherapy, were excluded. All participants were asked if they were taking immunosuppressive drugs.
c
Antibiotics for LD had been initiated for >48 h at the time of study enrollment.