Amoxicillin for Hypersensitivity

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Children's Medical Center Dallas, Dallas, TX
Hypersensitivity+2 More
Amoxicillin - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a primary care pediatrician can safely delabel patients with a penicillin allergy label.

See full description

Eligible Conditions

  • Hypersensitivity
  • Penicillin Allergy
  • Penicillin Reaction

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Amoxicillin will improve 2 primary outcomes and 1 secondary outcome in patients with Hypersensitivity. Measurement will happen over the course of Day 1.

Month 14
Penicillin allergy labeling in subjects with negative amoxicillin challenge
Day 1
Subjects stratified as low-risk with a negative immediate amoxicillin challenge in the pediatric primary care setting
Subjects who complete risk-stratification of penicillin allergy in the pediatric primary care setting

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Side Effects for

Benzyl Penicillin
Congestive heart failure
0%
Hypovolemic shock
0%
Renal failure
0%
Respiratory failure
0%
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT01399723) in the Benzyl Penicillin ARM group. Side effects include: Congestive heart failure with 0%, Hypovolemic shock with 0%, Renal failure with 0%, Respiratory failure with 0%.

Trial Design

1 Treatment Group

Pediatric Patients with a history of penicillin allergy
1 of 1
Experimental Treatment

This trial requires 200 total participants across 1 different treatment group

This trial involves a single treatment. Amoxicillin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Pediatric Patients with a history of penicillin allergy
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benzylpenicillin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10-14 months after amoxicillin challenge
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10-14 months after amoxicillin challenge for reporting.

Who is running the study

Principal Investigator
T. C.
Prof. Timothy Chow, Assistant Professor
University of Texas Southwestern Medical Center

Closest Location

Children's Medical Center Dallas - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Children from ages 2-18 years with a history of parent-reported penicillin allergy.

Patient Q&A Section

What is hypersensitivity?

"The overall rate of HFI sensitivity was 14.3%. Hypersensitivity was more common in females and in Asians. Patients with HFI sensitivity were more likely to receive treatment by non-mainstream physicians. HFI is often a symptom of a more complex disorder or a side-effect of medical treatment. A diagnosis of HFI should prompt physicians to consider the possibility of such underlying conditions." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypersensitivity?

"What are the signs of hypersensitivity include: itching, wheezing, chest tightness, sweating, and facial edema. Hypersensitivity can be triggered by cold temperatures, or exposure to plants, pesticides, or other materials. It can be classified into three groups: IgE mediated hypersensitivity (drug, insect and plant-arthropod exposures), idiopathic hypersensitivity (sensitization to other allergens), or non IgE hypersensitivity (drugs used for relief of symptoms such as aspirin or opiates). Diagnosing hypersensitivity from other causes is difficult." - Anonymous Online Contributor

Unverified Answer

What causes hypersensitivity?

"Hypersensitivity is a disorder that can result from a variety of factors, but can be caused by factors that do not affect the body's usual functions. In hypersensitivity, the underlying cause is a reaction to a food, environmental irritant, drug, or allergen, most often resulting in allergic symptoms.\n" - Anonymous Online Contributor

Unverified Answer

How many people get hypersensitivity a year in the United States?

"The combined prevalence of dermatitis contact dermatitis and insect bite hypersensitivity in the United Kingdom are reported here for the first time. An estimate of the number of patients with dermatitis contact dermatitis in the United Kingdom is a more accurate estimate of the global burden of skin and immune related disorders rather than estimating the number of patients with insect bite/pest bites. An estimate of the number of patients with hypersensitivity reactions to medicines in the United Kingdom is a more accurate estimation of the global burden of skin and immune related disorders rather than the number of patients with insect bite/pest bites." - Anonymous Online Contributor

Unverified Answer

Can hypersensitivity be cured?

"Hypersensitivity and H1 allergies cannot be cured. However, the benefits of avoiding an allergen to the extent of the individual's abilities may be of greater value in the long-term management of the conditions, even if there is still a risk of developing a allergic reaction. A large reduction in the number of occurrences may result from the reduced quantity of allergen present in the blood. However, as the immune response is suppressed, no rebound effect occurs. The avoidance of a potential allergen must be done on an individual basis." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypersensitivity?

"This guideline is part of our continuing effort to provide evidence-based medicine to our patients. There are many drugs and techniques that do not pose significant hazards to the patient, but that may nevertheless cause side effects. For these reasons, it is in a patient's best interest to seek the relevant specialists to treat hypersensitivity if present." - Anonymous Online Contributor

Unverified Answer

How does amoxicillin work?

"In all the studies, amoxicillin showed effectiveness without side effects against staphylococci, streptococci, and anaerobes, which are commonly present in chronic infections. Further study should be undertaken to determine its benefits in infections caused by these organisms." - Anonymous Online Contributor

Unverified Answer

Is amoxicillin typically used in combination with any other treatments?

"Although the most commonly used coadministered drug is amoxicillin only in about 25% of patients to date and thus the overall use of amoxicillin is limited, several studies, in particular those investigating a possible relationship between the level of amoxicillin resistance and treatment response, suggest that amoxicillin may be useful as a first line drug. These data should be confirmed by multi-center studies, and further studies are needed to assess the potential of amoxicillin for the management of acute sinonasal infections, the treatment of respiratory tract infections in patients with chronic lung disease, or in patients with immunodeficiency, especially with a decreased T cell count." - Anonymous Online Contributor

Unverified Answer

What is amoxicillin?

"In a clinical practice setting, the clinical impact of amoxicillin was modest after 4 months of therapy. To reduce the morbidity and the antibiotic resistance associated with amoxicillin use in the setting of treatment duration greater than 4 months, further studies are needed." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hypersensitivity?

"Subjects who have a history or suspicion of hypersensitivity disorders should consider clinical trial participation. In the case of serious adverse events, if those events are not explained by the clinical trial protocol or other investigations, consideration should be given to an investigation into drugs or medical devices triggering the events." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hypersensitivity?

"Hypersensitivity remains an elusive condition, affecting an estimated 1-3% of the population. Over 400 drug-sensitivities are described. Despite the rarity of the condition, research continues. Most hypersensitivity research is focused on the mechanism by which a sensitizing compound induces hypersensitivity. As hypersensitivity is an autoimmune disease, the mechanisms by which the immune system damages itself to mount an inflammatory response is the goal of many hypersensitivity research studies. Another goal is to identify non-drug-target allergens that could be more useful for immunotherapy, and to learn more about the role of the immune system in sensitization." - Anonymous Online Contributor

Unverified Answer

Is amoxicillin safe for people?

"Amoxicillin is well tolerated and safe in infants, toddlers, children, adolescents, and adults. The majority (73%) experienced transient problems but most recovered, with no long-term sequelae. Although amoxicillin may cause gastrointestinal issues, the number reported was small and none had severe sequelae." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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