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Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
NCT06303128 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is: \- In penicillin-allergic patients that are at low risk of having an allergic reaction, is a one-dose oral challenge with amoxicillin (a penicillin-based antibiotic) as safe and effective as a two-dose oral challenge? Participants will, after being identified as having a low-risk penicillin allergy, be administered oral amoxicillin in a controlled setting and then monitored for an allergic reaction. Researchers will compare participants that took one dose of amoxicillin to participants that took two doses of amoxicillin (a small dose and then a larger dose) to see if either group was more likely to develop an allergic reaction.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amoxicillin 250 MG
- DRUG Amoxicillin 62.5mg
- DRUG Amoxicillin 187.5mg
Study Locations (1)
Texas
- Texas Tech University Health Sciences Center — Lubbock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2024-02-03 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06303128
The ClinicalTrials.gov registry entry for NCT06303128 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is James Tarbox, MD, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Penicillin Allergy appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06303128 reports 1 study location spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06303128 about?
NCT06303128 is a clinical study titled "Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge". The goal of this clinical trial is to learn about dosing when testing to see if a penicillin allergy label can be removed from adults that had been labeled as "penicillin-allergic" previously. The main question it aims to answer is: \- In penicillin-allergic patients that are at low risk of having ...
What is the current status of trial NCT06303128?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2024-02-03. Estimated completion is 2026-12.
What conditions does trial NCT06303128 study?
This clinical trial studies the following conditions: Penicillin Allergy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06303128?
The interventions under investigation include: Placebo (DRUG), Amoxicillin 250 MG (DRUG), Amoxicillin 62.5mg (DRUG), Amoxicillin 187.5mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06303128?
This trial is sponsored by James Tarbox, MD, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06303128 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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