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NCT06303128 · ClinicalTrials.gov registry record · Phase 3
Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge
A Phase 3 study of Penicillin Allergy, sponsored by James Tarbox, MD.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
- 1
- Study location
NCT06303128: Recruiting Phase 3 study of Penicillin Allergy, sponsored by James Tarbox, MD.
NCT06303128 is a Phase 3 study of Penicillin Allergy that is actively recruiting participants, run by James Tarbox, MD. The registered enrollment target is 380 participants, above the 95-participant average among 3 other Penicillin Allergy trials with a reported enrollment target (300% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06303128, a Phase 3 study of Penicillin Allergy, is actively recruiting participants, sponsored by James Tarbox, MD.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Percentage of subjects that successfully complete either the one-dose or graded two-dose direct oral challenge with amoxicillin without adverse reactions during the challenge, as determined by no reaction reported at first follow up phone call.
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 |
What NCT06303128 shows while recruiting
NCT06303128 is an interventional study that assigns participants to a tested intervention. The registered 380 participants enrollment target is mid-sized for trials with a published cap, above the 95-participant average among 3 other Penicillin Allergy trials with a reported enrollment target (300% higher).
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.
NCT06303128 reports a single indexed study location in Texas.
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.
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).
Who is sponsoring clinical trial NCT06303128?
This trial is sponsored by James Tarbox, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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