A Multi-center Study of Spherule-Derived Coccidioidin (NCT00690092) | Clinical Trial Compass
CompletedPhase 3
A Multi-center Study of Spherule-Derived Coccidioidin
United States113 participantsStarted 2005-05
Plain-language summary
Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to C. immitis.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Good Health (absence of active medical disease)
* Meets criteria specific to population groups:
* Coccidioidomycosis Group:
* History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings
* Histoplasmosis Group:
* History of pulmonary histoplasmosis
* Naive Control Group:
* Lifetime residence in the states of WA, OR, ID, or MT
* Never employed as an agricultural worker
* Serology negative for C.immitis antibodies
Exclusion Criteria (All Groups):
* Active medical disease
* Alcohol abuse or illicit drug use
* Influenza-like illness within the past 4 weeks
* Immunizations within the past 4 weeks
* Current atopic or contact dermatitis, psoriasis, erythema nodosum, urticaria
* Current treatment with corticosteroids, cytotoxic or immunosuppressive drugs
* Immunodeficiency disease
* HIV infection
* Previous skin test with coccidioidin or SD Coccidioidin
* Pregnant or lactating
* Adverse reaction to thimerosal
* Adverse reaction to Candida or Trichophyton skin test antigens
Coccidioidomycosis Group:
* Current cavitary or disseminated coccidioidomycosis
* History of histoplasmosis, or blastomycosis
Histoplasmosis Group:
* History of coccidioidomycosis or blastomycosis
Naive Control Group:
* History of coccidioidomycosis, histoplasmosis, blastomycosis
* Travel for more than 30 days in designated areas of CA, AZ, NV, UT, NM, TX and Mexico, Central and South America. Travel for more than 7 da…
What they're measuring
1
To determine the ability of spherule-derived coccidioidin to detect cellular hypersensitivity to C. immitis by a positive DTH skin test in a population with a history of pulmonary coccidioidomycosis.