Clinical Trials Logo

Clinical Trial Summary

The investigators are conducting a prospective study to determine the safety and outcomes of placebo-controlled graded drug challenges without prior skin testing in patients with a low-risk history of antibiotic hypersensitivity reaction based on history alone. The investigators hypothesize that the rate of reaction to graded drug challenges without prior skin testing in patients with a low-risk history of drug hypersensitivity reaction based on history alone will not be meaningfully more than the rate of reaction to placebo. The investigators hypothesize that the rate of adverse reactions to drug challenges without prior skin testing will not be meaningfully more than the rate of adverse reactions with prior skin testing as was observed in the investigators' historical clinic cohort.


Clinical Trial Description

Graded drug challenges are the gold standard to exclude an immediate hypersensitivity reaction in patients with a low likelihood of drug allergy and are considered standard of care. Patients who tolerate a graded challenge are deemed to not be allergic to the drug and are not at increased risk for future reactions compared with the general population. Prior studies of graded challenges in appropriately selected patients have demonstrated low reaction rates with symptoms that were mainly mild and subjective in nature. The investigators are conducting a prospective study to determine the safety and outcomes of placebo-controlled graded drug challenges without prior skin testing in patients with a low-risk history of antibiotic hypersensitivity reaction based on history alone. Skin testing requires a separate visit and is, therefore, more time-consuming and costly than performing a graded challenge without skin testing. The investigators believe that they can determine if patients are at low-risk to react to an antibiotic based on a detailed history and, therefore, do not require skin testing prior to a challenge. Given the majority of symptoms to graded drug challenges reported in prior studies were mild and subjective, the investigators hypothesize that the rate of reaction to graded drug challenges without prior skin testing in patients with a low-risk history of drug hypersensitivity reaction based on history alone will not be meaningfully more than the rate of reaction to placebo. The investigators hypothesize that the rate of adverse reactions to drug challenges without prior skin testing will be not meaningfully more than the rate of adverse reactions with prior skin testing as was observed in the investigators' historical clinic cohort. All patients age 7 years or older with a history of a non-life-threatening reaction to an antibiotic are eligible to participate in a placebo-controlled graded drug challenge. The challenge is comprised of placebo followed by 30 minutes of observation, 1/10th of the treatment dose of the antibiotic the patient reported a reaction followed by 30 minutes of observation, and the full dose of the antibiotic followed by 1 hour of observation. All patients will be contacted via telephone within one month of a negative challenge to determine whether they experienced a delayed reaction. All patients will also be contacted via telephone within one year of a negative challenge to determine if they have safely taken the challenge drug. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03158831
Study type Interventional
Source Montefiore Medical Center
Contact
Status Completed
Phase Phase 1
Start date January 13, 2016
Completion date October 1, 2021

See also
  Status Clinical Trial Phase
Terminated NCT05563610 - Oral Penicillin Challenge and Allergy De-labeling in Children Phase 4
Completed NCT05020327 - Inpatient Penicillin Allergy Delabeling Study Phase 4
Completed NCT04441021 - Feasibility Assessment of Risk Stratification and Oral Challenge in Hospitalized Children at Low Risk for Antibiotic Allergy
Not yet recruiting NCT05956080 - Penicillin Allergy Delabeling Among Surgical Patients N/A
Recruiting NCT03757052 - Amoxicillin Challenge for Penicillin Allergy Diagnosis N/A
Completed NCT03702270 - The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal N/A
Recruiting NCT05464615 - Geisinger Antibiotic Allergy Pilot Program: Assess and Address Early Phase 1
Completed NCT03702283 - Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting N/A
Not yet recruiting NCT03499457 - Penicillin Allergy in Shfayim Clinic N/A
Completed NCT01667055 - The Diagnosis of Beta-lactam Hypersensitivity in Thailand
Withdrawn NCT00589251 - Equivalency of Penicilloate Skin Test Reactivity Prepared by a Modified Alkaline Hydrolysis Technique N/A
Completed NCT04620746 - Penicillin Allergy Testing in STD Clinics Phase 4
Completed NCT05090527 - Penicillin Allergy Delabeling Project N/A
Completed NCT03033394 - Beta-lactam Pharmacokinetics in Secondary Care
Completed NCT02036840 - Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients N/A
Terminated NCT00363688 - Treating Patients With a History of Non-Life Threatening Allergic Reaction to Penicillin With Penicillin Phase 4
Recruiting NCT06303128 - Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge Phase 3
Completed NCT03942731 - Penicillin Allergy Testing and Resensitization Rate
Completed NCT05010304 - Penicillin De-labeling in the Pediatric Primary Care Setting Phase 4
Completed NCT03404804 - Oral Challenge in the Pediatric ED Phase 4