Z88.0
Conditions
Interventions
Group 1: Adult patients receive a single oral dose of amoxicillin 1000 mg under inpatient conditions.
Children and adolescents receive 1st administration of weight-adapted single dose of 20 mg/kgKG a
Sponsors
ABS-Netzwerk Westfalen-Lippe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In the adult clientele: All adults aged 18 and over who are currently inpatients in one of the two participating adult care clinics are included, as well as outpatients who are admitted to the study after a previous inpatient stay or who are referred from a GP or specialist practice providing care. According to the PEN-FAST score, patients must have a low or very low risk of a genuine allergy to penicillins. In the pediatric clientele: All children and adolescents up to 18 years of age who are identified on the basis of the criteria described above are included. These criteria are analogous to those of the adult clientele and take into account both the anamnestic information of the parents or caregivers as well as medical reports that lead to a positive anamnesis for the presence of a “penicillin allergy”. When selecting pediatric patients, particular attention is paid to the ability of the parents or legal representatives to give consent and the consent of both parents is required to ensure that participation is in the best interests of the child. According to the pediatric risk score, patients must have a low risk of having a true allergy to penicillins.
Exclusion criteria
Exclusion criteria: Patients who are unable to give informed consent (in the adult clientele) are excluded, as well as those whose current medical situation makes it appear impractical to conduct the study. This includes, for example, patients who have received antibiotics in the 7 days prior to the study, as well as those whose medical condition makes a possible additional impairment due to an ADR appear intolerable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive evidence of an anamnestically reported “penicillin allergy” yes/no Review of allergic reactions at the time of initial oral exposure (day 0), 24 h (day 1) after oral exposure, pediatric patients additionally on day 3 and day 7. Pediatric patients are evaluated by telephone on days 3 and 7 using a standardized questionnaire. In the event of clinical abnormalities, patients are presented again at any time up to day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number and type of adverse drug reactions (ADRs): Documentation of type-I and type-IV allergic reactions based on clinical evaluation. Fixed assessment times: At the time of initial oral exposure (day 0), 24 h (day 1) after oral exposure, pediatric patients additionally by telephone on day 3 and day 7. In the event of clinical abnormalities, patients should be presented again at any time up to day 7. - Problems with the practical implementation of direct oral provocation: questioning of the healthcare professionals involved and the patients. - Patient compliance with protracted administration (pediatric): Patient/parent survey on implementation following day 7 (by telephone). - Anamnestic information from patients associated with the assumption of an existing allergy: Survey in the course of the initial survey via questionnaire. | — |
Countries
Germany
Contacts
Public ContactAnke Hildebrandt
St. Vincenz-Krankenhaus Datteln
Outcome results
None listed