Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||N/A - 16 Years|
- - Children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test.
- - Refusal of the legal representatives of the subject for their child to participate in the study, - If his age permits, refusal of the subject to participate in the study, - Subject aged over 16, - Pregnancy, - Absence of affiliation of the subject to a social security scheme, - Skin tests with incriminated beta-lactam already made before the consultation, - Existence of contraindications to the realization of oral reintroduction drug test with the suspected antibiotic, - Existence of criteria in the initial reaction suggestive of a non-low risk of IgE-mediated or delayed hypersensitivity to the incriminated beta-lactam, Taking antihistamine, corticosteroids or beta-blockers within 5 days prior to the oral reintroduction drug test, - Travel abroad of the child scheduled within 7 days of the oral reintroduction drug test.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Nantes University Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Hypersensitivity, Beta Lactam Adverse Reaction|
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
LUC COLAS, MD
For additional contact information, you can also visit the trial on clinicaltrials.gov.