Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.

The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:
* Main indicators: the eradication rate of Helicobacter pylori for eradication.
* Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.

Start Date04 Sep 2023

Sponsor / Collaborator-

CTRI/2023/08/056474 / Not yet recruitingNot Applicable

Effectiveness and Tolerability of Cephalexin and Clavulanic Acid Fixed Dose Combination,Amoxicillin and Clavulanic Acid Fixed Dose Combination, and Azithromycin in Patients withPHARYngitis in India: A Real-World RetroSPective Study from ElectrOnic Medical Records(PHARYSPOR) - NIL

Start Date23 Aug 2023

Sponsor / Collaborator

Sun Pharmaceutical Industries Ltd.

NCT06004401 / Not yet recruitingNot ApplicableIIT

The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori

Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric cancer. In recent years, the resistance rate of Hp to antibiotics, especially Clarithromycin and Metronidazole, has increased, leading to the gradual reduction of the eradication rate . In addition, PPI is mainly metabolized by CYP2C19 in the body, and the genetic polymorphism of this enzyme activity in the population results in significant individual differences in the acid suppression effect of PPI; At the same time, PPI will affect the metabolism of other drugs by affecting the activity of CYP2C19 in the liver.
Potassium ion competitive acid blockers (P-CABs) are a new type of antacids, and vonoprazan is a representative of this class of drugs. Compared to traditional proton pump inhibitors, it has higher selectivity towards proton pumps, stronger acid inhibition effect, faster onset time , longer sustained acid inhibition time, and less influence from food consumption. Therefore, it can effectively eliminate Helicobacter pylori . In recent years, Vonoprazan has been widely used in the eradication treatment of Hp . Vonoprazan can inhibit gastric acid secretion more strongly and persistently, therefore, eradication plans based on vonoprazan are expected to improve the eradication rate of Hp.
Related studies have shown that compared to traditional proton pump inhibitors, vonoprazan has a more significant therapeutic effect and higher safety in the treatment of Helicobacter pylori positive peptic ulcers due to its unique mechanism of action..In recent years, there have been reports of successful eradication of multi drug resistant Hp retreated patients with Semisynthesis tetracycline. Some domestic scholars are also gradually trying to use Semisynthesis tetracycline to eradicate Hp infection. Minocycline is a Semisynthesis tetracycline. The drug sensitivity test in vitro showed that the resistance rate of Hp to Minocycline was low , suggesting that Minocycline may have a better effect on eradicating Hp.
Therefore, the investigators further carried out a prospective single center clinical study and set up a penicillin negative group. One month after treatment, 13C carbon breath test was performed to check the efficacy, in order to explore the efficacy of the combination therapy based on vonoprazan in eradicating Hp, especially whether it is a good choice for penicillin allergy.

Start Date20 Aug 2023

Sponsor / Collaborator

Shanghai Changzheng Hospital

100 Clinical Results associated with Amoxicillin Sodium

100 Translational Medicine associated with Amoxicillin Sodium

100 Patents (Medical) associated with Amoxicillin Sodium

Literatures (Medical) associated with Amoxicillin Sodium

01 Aug 2023·Research in social & administrative pharmacy : RSAP

Antibiotic prescribing trends in primary care 2014-2022.

Article

Author: Jarman, Ian ; McCabe, Philippa G ; McCloskey, Alice P ; Malabar, Lucy ; Gitsham, Andrew

Antimicrobial resistance (AMR) is a global healthcare challenge that governments and health systems are tackling primarily through antimicrobial stewardship (AMS). This should, improve antibiotic use, avoid inappropriate prescribing, reduce prescription numbers, aligning with national/international AMS targets. In primary care in the United Kingdom (UK) antibiotics are mainly prescribed for patients with urinary and respiratory symptoms (22.7% and 46% of all antibiotic prescriptions respectively). This study aimed to capture the time-series trends (2014-2022) for commonly prescribed antibiotics for respiratory and urinary tract infections in primary care in England. Trends for Amoxicillin, Amoxicillin sodium, Trimethoprim, Clarithromycin, Erythromycin, Erythromycin ethylsuccinate, Erythromycin stearate, Doxycycline hyclate, Doxycycline monohydrate and Phenoxymethylpenicillin (Penicillin V) were determined. In doing so providing evidence regarding meeting UK antibiotic prescribing rate objectives (a 15% reduction in human antibiotic use 2019-2024). Time series trend analysis of 62,949,272 antibiotic prescriptions from 6,370 General Practices in England extracted from the National Health Service (NHS) Business Services Authority web portal were explored. With additional investigation of prescribing rate trends by quintiles of the Index of Multiple Deprivation (IMD). Overall, there is a downwards trend in antibiotic prescribing for those explored. There is an association between IMD, geographical location, and higher antibiotic prescribing levels (prescribing hot spots). England has a well-documented North-South divide of health inequalities, this is reflected in antibiotic prescribing. The corona virus pandemic (COVID-19) impacted on AMS, with a rise in doxycycline and trimethoprim prescriptions notable in higher IMD areas. Since then, prescribing appears to have returned to pre-pandemic levels in all IMDs and continued to decline. AMS efforts are being adhered to in primary care in England. This study provides further evidence of the link between locality and poorer health outcomes (reflected in higher antibiotic prescribing). Further work is required to address antibiotic use in hot spot areas.

26 Jul 2023·Journal of investigational allergology & clinical immunology

English

Article

Author: Lamoureux, F ; Varin, R ; Belaid, I ; Hervouët, C ; Martinet, J ; Tétart, F ; Gondé, H

01 Jul 2023·Pharmaceutics

Rectal Bioavailability of Amoxicillin from Hollow-Type Suppositories: Effect of Chemical Form of Amoxicillin.

Article

Author: Amirapu, Satya ; Wu, Zimei ; Hanning, Sara M ; Purohit, Trusha J

Rectal drug administration could offer advantages in the delivery of medicines for children by avoiding swallowability issues, improving stability and enabling administration by caregivers. This study aimed to evaluate the rectal bioavailability of hollow-type suppositories (HTS) and understand the effect of two chemical forms of amoxicillin: amoxicillin sodium (AS) or amoxicillin trihydrate (AMT). HTS were prepared by incorporating a lipophilic core containing the antibiotic with a polyethylene glycol (PEG) shell. Formulations were characterised in vitro, and the absolute bioavailability was determined in a rabbit model, while drug-base interactions were evaluated using X-ray diffraction crystallography (XRD), differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy. The in vitro amoxicillin release from AMT HTS was delayed, taking 27.3 ± 4.9 h to release 50% drug compared with 1.7 h for the AS HTS, likely due to solubility differences between AMT and AS. The presence of orthorhombic AMT and anhydrous AS crystals in respective HTS was confirmed via XRD and DSC. PEG shells were able to protect the drug chemical stability when stored at 25 °C/60% RH. Despite the difference in their in vitro release rates, a similar rectal bioavailability was found in both forms of amoxicillin (absolute bioavailability 68.2 ± 6.6% vs. 72.8 ± 32.2% for AMT HTS and AS HTS, respectively; p = 0.9682). Both HTS formulations showed little or no irritation to the rectal mucosa following a single dose.

News (Medical) associated with Amoxicillin Sodium

10 May 2023

·www.globenewswire.com

Phathom Pharmaceuticals Presents New Data at Digestive Disease Week® (DDW) 2023

Higher H. pylori eradication rates demonstrated with vonoprazan-based regimens vs. lansoprazole triple therapy, regardless of different baseline demographics and clinical characteristics Meta-analysis shows potassium-competitor acid blockers (PCABs), including vonoprazan, provide a longer duration of pH >4, higher predicted Erosive GERD healing rates, and lower probabilities of failure to achieve healing Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today announced new data from two post-hoc analyses presented in poster presentations at Digestive Disease Week® (DDW) 2023, held May 6-9 in person in Chicago, IL and virtually. Sub-group analysis from PHALCON-HP Trial: H. pylori eradication rates with vonoprazan Data from a post-hoc subgroup analysis of the pivotal Phase 3 PHALCON-HP study demonstrated higher H. pylori eradication rates with vonoprazan-based regimens, as compared to proton pump inhibitor (PPI) lansoprazole-based triple therapy, regardless of different baseline demographics and clinical characteristics and provide further insights into the PHALCON-HP study. “These results provide meaningful insight and increased confidence in the ability for vonoprazan-based regimens to deliver higher H. pylori infection eradication rates, as compared to PPI-based clarithromycin and amoxicillin triple therapy, regardless of a patient’s varying demographics, including age, weight, ethnicity, and other clinically important characteristics,” said Professor William D. Chey, M.D., AGAF, FACG, FACP, Pollard Professor of Medicine and Chief of the Division of GI & Hepatology at the University of Michigan. “Acid suppression remains a critical factor in helping to address unmet needs associated with H. pylori treatments, and these data further demonstrate the potential to meaningfully enhance eradication rates across different baseline demographics by replacing PPI-based treatment with vonoprazan.” PHALCON-HP was the largest Phase 3 registration trial ever conducted in H. pylori infection and randomized 992 patients with confirmed H. pylori infection at sites across the United States and Europe. The pivotal trial demonstrated superiority of vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), in combination with amoxicillin (vonoprazan dual therapy), and vonoprazan in combination with clarithromycin and amoxicillin (vonoprazan triple therapy), over the commonly used PPI-based triple regimen of lansoprazole, amoxicillin and clarithromycin. In the PHALCON-HP sub-group analyses, the magnitude of treatment effect for vonoprazan dual therapy and vonoprazan triple therapy versus lansoprazole triple therapy were generally similar across subgroups based on baseline demographics and clinical characteristics, including age, sex, race, ethnicity, region, and body mass index (BMI). Model-based meta-analysis of the relationship between pH control and Erosive GERD healing rates Additionally, in a separate poster presented at DDW, a model-based meta-analysis evaluated the relationship between pH control and healing rates of Erosive Gastroesophageal Reflux Disease (GERD), also known as erosive esophagitis, across different classes of acid-suppressant drugs. Published pharmacodynamic (PD) and clinical studies of anti-secretory drugs, including histamine2–receptor antagonists (H2RAs), PPIs, and PCABs, including vonoprazan, were used to evaluate the mean percent of time with pH >4.0 per 24 hours (after 5-8 days of dosing), and mucosal healing in patients with Erosive GERD, respectively. Acid suppression has been shown to be an important factor in the treatment of acid-related gastrointestinal disorders, especially Erosive GERD. Previous research has concluded that reduction of GERD symptoms and mucosal healing correlates with the number of hours that intragastric acid is suppressed to a pH > 4.0. In the model, PCABs were shown to provide the longest duration of pH >4.0, higher predicted healing rates, and lower probabilities of failure to achieve 80-90% healing rates, as compared to H2RAs and PPIs. By week 4, PCABs attained median healing rates nearly 200% higher than H2RAs and 25% higher than PPIs (~90% for PCABs, ~30% for H2RAs, 70% for PPIs). By week 8, median healing rates for PCABs increased to nearly 100%, whereas H2RAs and PPIs reached ~50% and ~78%, respectively. “This provides additional confirmation about the important potential of the PCAB treatment class for gastroenterologists and their patients and suggests the novel mechanism of action of PCABs achieve more effective and prolonged acid suppression which may have a meaningful clinical impact in creating an environment more conducive to healing of Erosive GERD,” said Eckhard Leifke, M.D., Chief Medical Officer of Phathom. “Phathom understands the clinical importance of bringing the first PCAB to the U.S. market as an exciting development in the treatment of Erosive GERD.” Phathom also has a physical presence on the exhibit floor at booth #1815 throughout the medical meeting. Following the conclusion of DDW 2023, the abstracts will be posted to Phathom’s publications and scientific section of the company website. About Phathom Pharmaceuticals, Inc. Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). For more information about Phathom, visit the Company’s website at www.phathompharma.com and follow the Company on LinkedIn and Twitter. About DDW Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 6-9, 2023. The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultPhase 3

27 Feb 2023

·www.fiercehealthcare.com

Antibiotic misuse during COVID underscores importance of stewardship programs, says CDC

Research in JAMA Health Forum shows that antibiotics to treat COVID-19, a viral infection for which antibiotics are useless, were most dispensed in emergency departments and in practice-based telemedicine consultations. The CDC says that underscores the need to bolster antimicrobial stewardship programs. The misuse of antibiotics during the COVID-19 pandemic points to a need for provider systems to shore up their antimicrobial stewardship programs, according to experts at the Centers for Disease Control & Prevention A new research letter in JAMA Health Forum examined the use—or, rather, misuse—of antibiotics to treat COVID-19 for people enrolled in commercial health insurance plans. Researchers with the Children’s Hospital of Pittsburgh found that antibiotics were most prescribed for COVID-19 patients in emergency departments and in practice-based telemedicine consultations. Kristin Ray, M.D., the corresponding author, told Fierce Healthcare in an email that “what we found was that antibiotics were sometimes prescribed for patients with COVID-19, despite no evidence that these treatments would improve outcomes.” Lauri Hicks, the director of the CDC’s Office of Antibiotic Stewardship, and Sarah Kabbani, M.D., deputy in that office, told Fierce Healthcare in an email that “antibiotic use has been on a roller coaster ride that tracks with the waves of the pandemic. In the early months of the pandemic, healthcare providers were desperate to find options to treat patients. Many reached for antibiotics even though we know that antibiotics don’t treat viral illnesses like COVID-19.” Hicks and Kabbani said that healthcare systems need to bolster their antimicrobial stewardship programs to limit misuse of antibiotics. “To ensure antibiotics are being used appropriately even during a crisis, stewardship program activities must be appropriately resourced to continue that work,” they wrote. “Many pharmacists and physicians, who usually were responsible for antibiotic stewardship, had skills that were used for other roles during the pandemic response.” They added that “some people develop a bacterial infection requiring antibiotics after having a viral infection, but that has been shown to be uncommon in people with COVID-19.” The research letter found that azithromycin was the antibiotic prescribed the most, and the researchers said it may have been "selected for its potential anti-inflammatory and antiviral properties, especially before more data were available." Hicks and Kabbani cited “unreliable reports" that the antibiotic was helpful to patients with COVID-19, leading to inappropriate use. The research letter said that both adults and those aged 6 to 17 years most prescribed antibiotics at EDs and in practice-based telemedicine visits. “Amoxicillin use among the youngest group suggests concerns about associated, but undiagnosed, bacterial infection such as otitis media or pneumonia,” the research letter said. Data were mined from 1,293,303 adult and 177,057 children outpatient visits in EDs, physician offices, practice-based telemedicine, direct-to-consumer telemedicine and urgent care centers between April 1, 2020, and May 31, 2022. Antibiotic use increased according to the age of the patients, 4% for children up to 5-years-old to 16% for adults from 45- to 64-years-old. Acute respiratory tract infection possibly caused by COVID-19 accounted for 20% of visits, and 7% of ARTI-related antibiotic dispensing among all age groups. Four percent of antibiotic prescriptions for children and adolescents were dispensed within two days of visits and 5% within seven days. For adults, 11% of antibiotic prescriptions were filled within two days of visits and 13% within seven days. “Among children younger than 6 years, the most common antibiotic was amoxicillin (37%) followed by azithromycin (36%),” the research letter found. “In those aged 6 to 17 years and adults, azithromycin (68% and 70%) was more commonly received than amoxicillin (15% and 4%).” Children and adolescents were more likely to seek treatment at physician offices than adults (66% vs 51%). The second most frequented destination for children and adolescents were EDs (12% vs 18% for adults), followed by practice-based telemedicine (11% vs 17% for adults). The letter found that children under five were most likely to recieve antibiotics during a direct-to-consumer telehealth visit. Antibiotics were deployed most commonly in the Southern part of the U.S., according to the study. Amoxicillin was the antibiotic most prescribed to children 6 and younger, accounting for 37% of prescriptions, closely followed by azithromycin, which represented 36%. Those aged 6- to 17-years-old and adults were mostly prescribed azithromycin, accounting for 68% and 70% of prescriptions, respectively. Amoxicillin accounted for 15% of prescriptions for people aged six to 17, and 4% of those for adults. Misuse of antibiotics for COVID-19 has decreased, though it’s still a problem, according to the CDC. “While we were seeing surges in COVID-19, during 2020 and 2021 social distancing and behaviors like handwashing and masking led to less spread of the garden variety infections,” said Hicks and Kabbani. “This led to an overall decrease in antibiotic use in the community. However, antibiotic prescribing for people with COVID-19 in outpatient settings, hospitals, and nursing homes is common and increases with each pandemic wave, most of which is unnecessary.” COVID-19 also taught the importance of rapid diagnostic testing, they said. “There is opportunity to better leverage diagnostic testing to inform whether antibiotics should be used or not,” wrote Hicks and Kabbani. “Reliably distinguishing between a viral infection that doesn’t warrant antibiotics, but may require other treatment, and a bacterial infection that will respond to treatment with antibiotics is a powerful tool. The pandemic also taught us about the importance of the skills that are leveraged to run antibiotic stewardship programs to improve antibiotic use.” They added that patients and providers both can play a role when it comes to antibiotic stewardship. “As a caregiver or patient, instead of asking for antibiotics for an illness, ask what can be done to feel better,” said Hicks and Kabbani. “As a healthcare professional, every patient interaction related to an infection is an opportunity to educate about the importance of appropriate antibiotic use.”

100 Deals associated with Amoxicillin Sodium

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R&D Status

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05342532 (CTgov)	Phase 4	Helicobacter pylori infection	112	Omeprazole+Amoxicillin (High Dose Dual Therapy)	ulunnoiszx(ymgjhdlire) = nqhsdwnifz tjrxgiwati (uonwxzlsso, nrqapxbssx - tmhoxayirk) View more	-	01 Feb 2023
				Omeprazole+Clarithromycin+Amoxicillin (Standard Triple Therapy)	ulunnoiszx(ymgjhdlire) = qmbkcgkglc tjrxgiwati (uonwxzlsso, umnxatbbav - zidxwkiuvf) View more
NCT02891915 (CTgov)	Phase 4	Community Acquired Pneumonia \| Cataract Anterior Polar Dominant	385	aminopenicillin+clavulanate+amoxicillin trihydrate+Cefdinir (Short Course)	sxmtqqmute(falbnztpmn): Pr (Higher DOOR in Short-Course) = 0.69 (95% CI, 0.63 - 0.75), P-Value = <0.001 View more	-	03 Feb 2021
				aminopenicillin+clavulanate+amoxicillin trihydrate+Amoxicillin-Clavulanate+Cefdinir (Standard Course)
NCT02678195 (Pubmed \| Br Dent J)	Phase 4	Pneumonia in children	3,000	Amoxicillin for 3 days	krmcyvbfkd(jhsxbuanxx) = lglqgucxhc ygifihvqcg (ycjluuevyz ) View more	Positive	02 Jul 2020
				Amoxicillin for 5 days	krmcyvbfkd(jhsxbuanxx) = aaxinbgkkj ygifihvqcg (ycjluuevyz ) View more
NCT03609892 (Pubmed \| J Dig Dis)	Phase 4	-	658	Amoxicillin plus berberine	xvbtibxrcg(rfzybopljp) = bsyvycgvik ulburpvckq (hwwqzfhmmw ) View more	Negative	01 May 2020
				Tetracycline plus furazolidone	xvbtibxrcg(rfzybopljp) = ykrhfvchdf ulburpvckq (hwwqzfhmmw ) View more
NCT01435824 (CTgov)	Phase 2	-	16	Water-dissolved amoxicillin (Water as a Vehicle of Amoxicillin)	aejeciavcq(piqgpbxszd) = ykbrijpbuz fyojkokkjj (pagqekhexo, hmpaftuxar - psowtifpbp) View more	-	21 Jan 2020
				Human milk-dissolved amoxicillin (Human Milk as a Vehicle of Amoxicillin)	aejeciavcq(piqgpbxszd) = ugsfmpozut fyojkokkjj (pagqekhexo, txmsjlmpzu - gkclwgbjhr) View more
NCT01368341 \| EUCTR2010-023747-15-NO (Pubmed \| Clin Microbiol Infect)	Phase 4	Erythema Chronicum Migrans	-	Phenoxymethylpenicillin	uelyorvrlm(jlvsyvcvfr) = cgjdkibhlg garnxlsbog (eqxcbwfjhj )	-	01 Dec 2018
				Amoxicillin	uelyorvrlm(jlvsyvcvfr) = dotcetflrw garnxlsbog (eqxcbwfjhj )
NCT01200706 (Pubmed \| J Antimicrob Chemother)	Phase 4	Bacterial Infections \| Community Acquired Pneumonia First line	787	Amoxicillin	sftahnpzmk(nqeakpddpi) = kxrupuqjey cskityxdiy (tkzldonuyx, 8.7% - 13.2) View more	-	01 Aug 2017
NCT01613547 (Pubmed \| Br Dent J)	Not Applicable	Severe Acute Malnutrition	2,412	Amoxicillin	(mrhugujkaf) = zygjflntat hfotbqulyi (tdbrxytsfn ) View more	Negative	04 Feb 2016
				Placebo	(mrhugujkaf) = odzfkyvepm hfotbqulyi (tdbrxytsfn ) View more
NCT01593592 (CTgov)	Not Applicable	Helicobacter pylori infection	70	Placebo+Omeprazole+Amoxicillin+clarithromycin (Control Group)	cefesmcosg(nyvwrccbgh) = hykpplaqtz ezgfhclqxn (eyxeygaxdm, emiuxzqmyf - bsvftlwikt) View more	-	17 Aug 2015
				Lactobacillus reuteri+Omeprazole+Amoxicillin+clarithromycin (Lactobacillus Reuteri Group)	cefesmcosg(nyvwrccbgh) = tsupwkuhbx ezgfhclqxn (eyxeygaxdm, ejrouralnp - qkudcnrsym) View more
NCT01200706 (Pubmed \| J Antimicrob Chemother)	Phase 4	Pneumonia First line	820	Amoxicillin thrice daily	qeolakncst(lmhjlgymgs) = aaqxjpzwvj xdexxznqni (oggpyyykrl )	Positive	01 Jul 2014
				Amoxicillin twice daily	qeolakncst(lmhjlgymgs) = futtsiplix xdexxznqni (oggpyyykrl )

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