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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 48 hours

Trial details

NCT IDNCT00690092

SponsorNielsen BioSciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-09

View on ClinicalTrials.gov More Coccidioidomycosis trials