Scientists dig into the mystery of unexplained allergic shock
NCT ID NCT00719719
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 20 times
Summary
This study looks at people who have severe allergic reactions (anaphylaxis), especially when the cause is unknown. Researchers will do blood tests and bone marrow biopsies to find genetic or molecular clues. The goal is to understand what goes wrong in the body, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If this study succeeds, it could point toward better understanding of what causes unexplained anaphylaxis, potentially leading to new ways to predict or prevent severe allergic reactions.
- What could go wrong
- This is an observational study, not a treatment trial. It is small and early-stage, so findings may not lead to immediate therapies or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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115 people
The number who actually took part.
- Started
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Nov 2008
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Primary Clinical
- Ages
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13 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Subjects must be at least 13 years of age and no older than 75 years of age. * Subjects with IA must have a diagnosis of anaphylaxis occurring in the absence of an identifiable provoking agent or stimulus by a referral provider. Patient may carry both the diagnosis of 1A and the diagnosis of SA. * Subjects with SA must have a history of a severe reaction to a venom, food or, drug confirmed when possible by relevant skin testing, challenge testing, RAST, immunoCAP, or ELISA. within the past 36 months. * Subject must have had a doctor s office or ER visit, or a hospitalization for evaluation for anaphylaxis and have a history of involvement of the skin and/or mucosal tissue (e.g., flushing, itching, hives, angioedema, tongue swelling), and at least one of the following: * Respiratory compromise (e.g., dyspnea, hoarseness-laryngeal edema, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia). * Gastrointestinal symptoms of vomiting and/or diarrhea * Reduced blood pressure and/or associated symptoms of end-organ dysfunction (as evidenced hypotonia, hypoxia, collapse, syncope or incontinence). * Letter of referral from prospective study participant's referring physician, or similar primary provider - with copies of available medical evaluation and laboratory studies * Able and willing to consider a bone marrow biopsy and aspirate EXCLUSION CRITERIA: * Presence of conditions which in the judgment of the investigator or the referring physician may put the subject at undue risk for travel (including frequent episodes of IA not preventable by pre-medication, acute infection, severe thrombocytopenia \[minimum platelet count of 30,000\], or significant cardiovascular disease) * Any condition that - in the view of the principal investigator would make the subject unsuitable for enrollment in this study * Inability to provide informed consent * Pregnancy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States