ISRCTN20579216已完成未知
Penicillin allergy status and its effect on antimicrobial prescribing, patient outcomes, and antimicrobial resistance
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 823
研究概览
简要总结
2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36691248/ results of mixed-methods process evaluation embedded within the ALABAMA trial (added 25/01/2023) 2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-072253 (added 05/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 22/03/2024:
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or female, aged 18 years or above
- •3. Penicillin allergy (or sensitivity) record of any kind in their electronic health record
- •4. Prescribed systemic antibiotics, either: penicillin, cephalosporin, tetracycline, quinolone, macrolide, glycopeptide, aminoglycoside, oxazolidinone, monobactam or carbapenem class antibiotic or fosfomycin, nitrofurantoin, trimethoprim, clindamycin, rifampicin, colistin, metronidazole in the previous 24 months
- •NB Patients with a penicillin allergy record and a recent penicillin prescription would still be eligible because their allergy status will need assessment and records correcting if necessary.
- •Previous inclusion criteria:
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or female, aged 18 years or above
- •3. Penicillin allergy (or sensitivity) record of any kind in their electronic health record
- •4. Receipt of either: penicillin, cephalosporin, tetracycline, quinolone or macrolide class antimicrobial or fosfomycin, nitrofurantoin, trimethoprim, clindamycin in the previous 12 months
- •NB Patients with a penicillin allergy record and a recent penicillin prescription would still be eligible because their allergy status will need assessment and records correcting if necessary.
排除标准
- •Current exclusion criteria as of 22/03/2024:
- •1. Life expectancy estimated < 1 year by GP
- •2. Unable to attend hospital clinic where allergy testing takes place
- •3. Unsuitable for entry into testing pathway because:
- •3.1. Allergy history consistent with anaphylaxis to penicillin
- •3.2. History of toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) or any severe rash which blistered or needed hospital treatment, and acute generalised exanthematous pustulosis precipitated by a penicillin
- •3.3. Has been formally tested for penicillin allergy in the past and been found to be penicillin allergic
- •3.4. History of brittle asthma (had a course of steroids in the past 3 months) or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions
- •3.5. Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle
- •4. Pregnant
- •5. Breastfeeding mothers
- •6, Currently taking beta blocker medication and unable to temporarily withhold these on the day of penicillin allergy testing
- •7. Currently taking (or recently taken) systemic steroids and unable to top these for 10 days pre-testing
- •8. Currently taking antihistamines and unable to temporarily withhold these for 72 hours pre-testing
- •Previous exclusion criteria:
- •1. Life expectancy estimated < 1 year by GP
- •2. Unable to attend immunology clinic
- •3. Unsuitable for entry into testing pathway because:
- •3.1. Allergy history consistent with anaphylaxis to penicillin
- •3.2. History of toxic epidermal necrolysis, Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS) or any severe rash which blistered or needed hospital treatment, and acute generalised exanthematous pustulosis precipitated by a penicillin
- •3.3. Previous specialist investigation for penicillin allergy
- •3.4. History of brittle asthma (had a course of steroids in the past 3 months) or unstable coronary artery disease, or dermographism or other severe/poorly controlled skin conditions
- •3.5. Considered unsuitable for trial participation by the GP e.g. because of chaotic lifestyle
- •4. Pregnant/planning to become pregnant during the course of the study
- •5. Breastfeeding mothers
- •6. Currently receiving or due to start immunosuppressive medication
- •7. Currently taking (or recently taken, within 10 days) steroids
- •8. Currently taking antihistamines and unable to stop these for 4 days pre-testing
研究者
相似试验
已完成
不适用
Allergy Antibiotics And Microbial ResistanceInfectionNCT04108637University of Leeds823
已完成
不适用
B-lactam Databank AlgorithmBeta Lactam Adverse ReactionNCT06243380University Hospital, Antwerp921
已完成
不适用
The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin ChallengeHypersensitivity, ImmediateHypersensitivity, DelayedHypersensitivity ResponseNCT04454229Austin Health382
终止
4 期
Oral Penicillin Challenge and Allergy De-labeling in ChildrenPenicillin AllergyNCT05563610Phoenix Children's Hospital31
Unknown
不适用
Amoxicillin Challenge for Penicillin Allergy DiagnosisPenicillin AllergyNCT03757052CHU de Quebec-Universite Laval1,000