Z88
Conditions
Interventions
Group 1: The participants receive a weight-adjusted single dose of the index BLA to be tested orally under clinical supervised conditions.
On days 2 and 3, administration of the BLA orally is continue
Sponsors
Universitätsklinik für Kinder- und Jugendmedizin, Evangelisches Klinikum Bethel
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: - Case history of BLA allergy. - Pediatric risk assessment (adapted risk score) as low or very low risk for antibiotic allergy. - Patient consent and/or parental consent.
Exclusion criteria
Exclusion criteria: Patients who do not have a low or very low risk of antibiotic allergy and/or who have not given their consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of the simple and extended Pediatric Risk Score used to identify patients with low or very low risk of allergic reactions to BLA. The Pediatric Risk Scores are performed in advance of the study, together with a detailed medical history in order to select the participants. The results of the oral provocation test (OPT) are collected during clinical monitoring of the first dose and through a standardized telephone survey on days 7-9. In the event of clinical abnormalities, a follow-up appointment is scheduled at any time up to day 9. In addition there is a long-term follow-up after 1 year and after 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number and type of adverse drug reactions that occurred: Documentation of type I and type IV allergic reactions based on clinical evaluation. Fixed assessment times: At the time of initial oral exposure (day 1), by telephone on days 7-9. In case of clinical abnormalities, follow-up appointment at any time until day 9. - Problems associated with practical implementation of direct oral provocation: survey of the medical professionals involved, as well as the participants. - Participant compliance with prolonged administration: survey of participants or parents on implementation following days 7-9 (by telephone). - Anamnestic information from patients associated with the assumption of an existing allergy: collected during the initial assessment via questionnaire. - Long-term stability of de-labeling: two follow-up assessments one and two years after OPT to evaluate actual antibiotic use after de-labeling. In addition, request for active re-contact by the families in case of antibiotic use and feedback on whether tolerance is given yes/no (to the study center providing care). - Resource analysis: Documentation of personnel and cost requirements in connection with the implementation of the de-labeling strategy used. - Long-term stability of de-labeling: two follow-up assessments one and two years after OPT to evaluate actual antibiotic use after de-labeling. In addition, request active re-contact by the family in case of antibiotic use and feedback on whether tolerance is given yes/no to the study center providing care. - Resource analysis: Documentation of personnel and cost requirements in connection with the implementation of the de-labeling strategy used. | — |
Countries
Germany
Contacts
Public ContactJanina Soler Wenglein
Universitätsklinik für Kinder- und Jugendmedizin, Evangelisches Klinikum Bethel
Outcome results
None listed