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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No. Adult ? 18 ans, Patient with positive SARS-CoV-2 RT-PCR on nasopharyngeal sample at randomization or within the previous 48 hours, Patient with pneumonia diagnosed by thorax CT-scan or echography, Patient able to take per os medication, Written and signed consent of the patient, Patients affiliated with or benefitting from a social security scheme. Patient hospitalized in intensive care unit, Patient who received more than 24 hours of antibiotic treatment for the ongoing episode, Chronic renal failure with a Glomerular Filtration Rate. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Your Kid Probably Doesn’t Have a Penicillin Allergy. Research shows that most kids labeled allergic to penicillin actually aren’t. He was finishing his second year of medical school, his wife was working 12-hour shifts several days a week, and their son, who had just turned one year old, was especially fussy and kept pulling at his ear. His pediatrician diagnosed an ear infection and prescribed amoxicillin, a penicillin antibiotic to treat it. A week later, the toddler’s ear had stopped hurting, but he broke out in a rash. Vyles left class to meet his wife and the pediatrician. “This was our first child so we were both hyper-aware of anything happening,” said Vyles. The boy’s doctor blamed the antibiotic and added “allergic to penicillin” to his medical record. About 5 million kids in the United States age 18 and younger are identified as being allergic to penicillin, according to the American Academy of Pediatrics. Vyles’s son, most get the label before their third birthday. And it often sticks with them for the rest of their life. Vyles, an assistant professor of pediatrics at the Medical College of Wisconsin, worked in the allergy department of his hospital. Doctors there saw many cases like his son’s and were “questioning whether mild symptoms were associated with a true penicillin allergy,” he said. Most of the time, simple testing showed that there wasn’t a true allergy. Vyles’ son needed an antibiotic again, because of the presumed penicillin allergy, he was prescribed an expensive, less effective alternative. “I thought, ‘This is crazy, I don’t think he has a real allergy,’” said Dr. “I don’t think many of these kids have real allergies.” Dr. Vyles and his colleagues tested that supposition with a study of 500 kids ages 4 to 18 reported to be allergic to penicillin published in the journal Pediatrics in 2017. Based on medical records and parent questionnaires of their kid’s history of symptoms, the researchers determined that three-quarters of the children had never had a worrisome reaction to penicillin — and almost certainly never would. They followed up with allergy testing in 100 of those low-risk kids. The Medical College of Wisconsin study adds to a body of evidence suggesting that true penicillin allergies are rare and overdiagnosed. In fact, a review published last year in the Journal of the American Medical Association concluded that 19 out of 20 people who have been told they are allergic to penicillin actually aren’t. In many cases, penicillin is cheaper, safer and works better than alternatives and removing that false label in childhood offers a lifetime of benefit, according to Dr. David Stukus, M.D., associate professor of pediatrics at Nationwide Children’s Hospital in Columbus, Ohio. “It’s well-established that people who have a reported penicillin allergy have longer hospital stays, more antibiotic-resistant infections, and just poorer health outcomes in general compared to someone who doesn’t have that allergy listed,” he said. One reason doctors prefer to prescribe penicillin is because it’s effective at killing common disease-causing bacteria such as staphylococci staphylococci (staph) and streptococci (strep). “Penicillin is a really important antibiotic for common childhood infections — for everything from ear infections to strep throat to pneumonia,” said Dr. Allison Norton, M.D., an assistant professor of pediatrics at Vanderbilt University School of Medicine. Norton published a 2018 review in Pediatrics that demonstrated another crucial advantage of penicillin: It narrowly targets the bacteria that are making you sick. Due to the overuse of antibiotics, bacteria are growing increasingly resistant to the drugs, including penicillin. However, when an antibiotic is necessary, penicillin is often preferable to broad-spectrum drugs, which target a wide array of bacteria. The broad-spectrum drugs are more likely to kill off protective bacteria and spur antibiotic resistance. A study of 100,000 hospitalized adults found that people labelled as allergic to penicillin and treated with other antibiotics were more likely to develop potentially dangerous intestinal and skin diseases that those who did take it. Even without insurance, a 10-day course of liquid amoxicillin costs less than $10. If just half of the children in the United States who went to the doctor for an ear infection received amoxicillin instead of cefdinir (a common alternative), Norton said, it would save $34 million yearly. Parents may think a penicillin allergy runs in families (it often doesn’t) or mistake common side effects such as upset stomach or headache for allergy symptoms (they aren’t). Vyles and others suggests that misdiagnosis happens most often when a child taking the drug breaks out in a rash. “Most ear infections are preceded by a viral illness, and those commonly cause a rash,” he said. But in a few kids, the drug itself causes a red, flat rash — typically after they’ve been taking it for several days. Those rashes are harmless, go away on their own and seldom recur. Physicians used to assume a child who developed a mild drug-related rash could have a more serious reaction in the future. But research conducted over the last 10 years has shown that isn’t true. “Our understanding has really changed for the better,” said Dr. “But it can be quite confusing for parents because what they were told a few years ago or even what they themselves were told as children may be very different.” True allergic reactions, which occur when the body’s immune system overreacts, almost always come on suddenly — within minutes to a few hours of taking the drug. Symptoms commonly include hives, itchy eyes and swelling in the lips, tongue or face. In some cases, the allergy can cause vomiting and diarrhea. Rarely, penicillin allergies lead to anaphylaxis, a life-threatening reaction that affects the entire body. Even more rarely, a child will develop severe symptoms such as a high fever or blistered, peeling skin days or even weeks after taking the drug. Norton said parents should call their doctor if their child experiences any new symptoms while taking a drug. “Knowing what happens when a child has a reaction is key to figuring out how to manage these kids, so the parent really is an important part of this,” she said. If a health care provider is concerned about the symptoms, or just unsure, they may stop the penicillin and prescribe a different antibiotic, Dr. If that happens, be sure to follow up with your physician or allergy specialist to figure out if your child is really allergic. Allergy testing should be done in a doctor’s office or clinic where they have treatment on hand in case symptoms occur. It can involve a lot of waiting to see if anything happens, so bring a quiet activity to pass the time. Most kids undergo an “oral challenge” where they are given a small amount of the drug, then if there’s no reaction, the rest of the dose. If nothing happens after an hour or so, you’re good to go. If your child has a history of severe symptoms such as swelling, or shortness of breath or a rapid onset of hives, you will need to consult with an allergy specialist for a skin test. That involves first pricking the skin with an allergen, and if that doesn’t cause a red bump to form, using a small needle to place more of the allergen under the skin. (The procedure is bloodless and less painful than it sounds.) If there’s no reaction at the testing sites, the doctor will do an oral challenge to confirm your child isn’t allergic. If your child passes the tests, the next step is to remove the “allergic to penicillin” label from their medical records at doctors’ offices, pharmacies, school, camp and elsewhere. “Once that label is on, it’s kind of a pain in the butt to get it off,” said Dr. Vyles said that after passing an oral challenge, the boy was officially “delabeled.” When his younger son had the same issue, Dr. Vyles made sure that he also promptly underwent an oral challenge to keep from being stuck with the label. Even if your child turns out to be allergic to penicillin, talk to your doctor about repeating the tests in a few years, advised Dr. Ninety percent of children with the allergy outgrow it by age 10. In fact, parents who think they are allergic should also talk to their doctor about testing, he said. “Now we know it doesn’t need to be a lifelong label.” Teresa Carr is an award-winning science journalist based in Texas who specializes in science and health writes the Matters of Fact column for Undark. Objective To date, no randomised trials have compared the efficacy of vonoprazan and amoxicillin dual therapy with other standard regimens for Helicobacter pylori treatment. This study aimed to investigate the efficacy of the 7-day vonoprazan and low-dose amoxicillin dual therapy as a first-line H. pylori treatment, and compared this with vonoprazan-based triple therapy. Design This prospective, randomised clinical trial was performed at seven Japanese institutions. pylori –positive culture test and naive to treatment were randomly assigned in a 1:1 ratio to either VA-dual therapy (vonoprazan 20 mg+amoxicillin 750 mg twice/day) or VAC-triple therapy (vonoprazan 20 mg+amoxicillin 750 mg+clarithromycin 200 mg twice/day) for 7 days, with stratification by age, sex, H. Eradication success was evaluated by 13 C-urea breath test at least 4 weeks after treatment. Results Between October 2018 and June 2019, 629 subjects were screened and 335 were randomised. The eradication rates of VA-dual and VAC-triple therapies were 84.5% and 89.2% (p=0.203) by intention-to-treat analysis, respectively, and 87.1% and 90.2% (p=0.372) by per-protocol analysis, respectively. VA-dual was non-inferior to VAC-triple in the per-protocol analysis. The eradication rates in strains resistant to clarithromycin for VA-dual were significantly higher than those for VAC-triple (92.3% vs 76.2%; p=0.048). The incidence of adverse events was equal between groups. Conclusion The 7-day vonoprazan and low-dose amoxicillin dual therapy provided acceptable H. pylori eradication rates and a similar effect to vonoprazan-based triple therapy in regions with high clarithromycin resistance. helicobacter pylori - treatment antibiotics - clinical trials gastric inflammation clinical trials. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. helicobacter pylori - treatment antibiotics - clinical trials gastric inflammation clinical trials. Macrolides, including clarithromycin, readily induce changes in the resistome of Helicobacter pylori, and the clarithromycin resistance of H. Usage of clarithromycin should be discontinued as an empirical treatment in wide-scale strategies for H. Vonoprazan strongly inhibits gastric acid secretion, and vonoprazan-based triple therapy (VAC-triple) achieves sufficient eradication rates and high safety. Vonoprazan and low-dose amoxicillin dual therapy for 7 days (VA-dual) is a regimen with minimal usage of antibiotics and is simpler than current H. VA-dual achieved acceptable eradication rates of 85% in intention-to-treat and 87% in per-protocol analyses. VA-dual achieved an eradication rate of over 85% for both clarithromycin-susceptible and clarithromycin-resistant strains, and achieved a higher eradication rate than VAC-triple against clarithromycin-resistant strains. How might it impact on clinical practice in the foreseeable future? In the era of growing antimicrobial resistance, VA-dual is a potential new first-line H. pylori therapy for cases of high clarithromycin resistance because it provides an acceptable eradication rate and high safety, and will have a potentially less negative impact on future antimicrobial resistance of H.
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