scholarly journals Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of Helicobacter pylori: Randomized ERADICATE Hp Trial

Antibiotics ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. 685 ◽  
Author(s):  
Ira N. Kalfus ◽  
David Y. Graham ◽  
Dennis S. Riff ◽  
Raymond M. Panas
Keyword(s):  
Helicobacter Pylori ◽  
Eradication Rate ◽  
Study Drug ◽  
Standard Of Care ◽  
Empiric Therapy ◽  
World Health ◽  
Double Blind Study ◽  
Double Blind ◽  
Treatment Naïve ◽  
H Pylori

Due to increasing resistance to commonly used antibiotics, the World Health Organization and Food and Drug Administration have advocated the development of new therapeutic regimens for Helicobacter pylori (H. pylori). This phase three, double-blind study (ERADICATE Hp) randomized (2:1) treatment-naïve adults with H. pylori infection and dyspepsia to RHB-105 (an all-in-one combination of omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo, both administered every 8 h for 14 days. The H. pylori eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28–35 days post-completion of therapy, was compared (one-sample Z-test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures. The mITT H. pylori eradication rate (95% CI) with RHB-105 of 89.4% (82.0–96.8%) was greater than both the literature-derived comparator rate (P < 0.001) and the standard-of-care rate of 63.0% (44.8–81.1%) (P = 0.006). Adverse events with an incidence ≥5% for RHB-105 were diarrhea (12.7%), headache (11.9%), chromaturia (9.3%), abdominal tenderness (6.8%), and dizziness (5.1%). No leukopenia was noted. RHB-105 (Talicia®) proved to be a safe and effective empiric therapy for H. pylori eradication.

scholarly journals Comparison of combination of probiotic and standard therapy compared to standard therapy on eradication of Helicobacter pylori infection in children

2016 ◽  
Vol 50 (1) ◽  
pp. 38
Author(s):  
Fransisca Theresia Aryani ◽  
Agus Firmansyah ◽  
Abdul Latief
Keyword(s):  
Helicobacter Pylori ◽  
Treatment Group ◽  
Side Effects ◽  
Standard Therapy ◽  
Eradication Rate ◽  
Controlled Trial ◽  
Control Group ◽  
Double Blind ◽  
Cancer Management ◽  
H Pylori

Background Helicobacter pylori (H. pylori) infection is thought to be the etiology of chronic gastritis, peptic ulcer, and risk factor for gastric cancer. Management of H. pylori infection in children is associated with several problems such as compliance to therapy, untolerated side effects, and antibiotic resistance. Probiotic is reported to give beneficial effect in the management of H. pylori infection and there is no study yet on the effect of probiotic in eradication of H. pylori infection in Indonesian children.Objectives To study the effect of additional probiotic in the standard therapy on the rate of H. pylori infection eradication in children and its side effect.Methods This was a double blind randomized controlled trial performed in 23 children with H. pylori infection at Kampung Melayu and Rawa Bunga District. The diagnosis was determined based on Helicobacter pylori stool antigen test (HpSA). Subjects were randomly assigned to either receive receive amoxiycilin, clarithromycin, omeprazole, and probiotic (2 x 109 cfu of Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12) or amoxicillin, clarithromycin, omeprazole dan placebo (maltodextrin). HpSA examination was evaluated again after 2 weeks of therapy.Results Two of 13 subjects in the treatment group and 6 of 10 subjects in the control group experienced side effects. Eradication rate in the treatment group is higher than the control group (13/13 vs 7/10) but the correlation between additional probiotic with the eradication rate of H. pylori is not statistically significant.Conclusions Probiotic can reduce the incidence of side effects due to antibiotic used in H. pylori eradication (2/13 vs 6/10, p < 0.012). [Paediatr Indones. 2010;50:38-41].

scholarly journals Different dose of new generation proton pump inhibitors for the treatment of Helicobacter pylori infection: A meta-analysis

2021 ◽  
Vol 35 ◽  
pp. 205873842110303
Author(s):  
Wenwen Gao ◽  
Xiang Zhang ◽  
Yanhui Yin ◽  
Shuwen Yu ◽  
Lu Wang
Keyword(s):  
Helicobacter Pylori ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Eradication Rate ◽  
Standard Dose ◽  
Statistical Significance ◽  
High Dose ◽  
Clarithromycin Resistance ◽  
H Pylori ◽  
New Generation

The evidence on whether high-dose new generation proton pump inhibitors (PPIs) including rabeprazole and esomeprazole achieve a higher eradication rate of Helicobacter pylori has not been assessed. The primary comparison was eradication and adverse events (AEs) rate of standard (esomeprazole 20 mg bid, rabeprazole 10 mg bid) versus high-dose (esomeprazole 40 mg bid, rabeprazole 20 mg bid) PPIs. Sub-analyses were performed to evaluate the eradication rate between Asians and Caucasians, clarithromycin-resistance (CAM-R) strains, and clarithromycin-sensitivity (CAM-S) strains of different dose PPIs. We conducted a literature search for randomized controlled trials comparing high-with standard-dose esomeprazole and rabeprazole for H. pylori eradication and AEs. A total of 12 trials with 2237 patients were included. The eradication rate of high-dose PPIs was not significantly superior to standard-dose PPIs regimens: 85.3% versus 84.2%, OR 1.09 (0.86–1.37), P = 0.47. The high dose induced more AEs than those of the standard dose, but didn’t reach statistical significance (OR 1.25, 95% CI: 0.99–1.56, P = 0.06). Subgroup analysis showed that the difference in eradication rate of PPIs between high- and standard-dose groups were not statistically significant both in Asians (OR 0.99, 95% CI 0.75–1.32, P = 0.97) and Caucasians (OR 1.27, 95% CI 0.84–1.92, P = 0.26). Furthermore, there were similar eradication rates in CAM-S (OR 1.2; 95% CI 0.58–2.5; P = 0.63) and CAM-R strains (OR 1.08; 95% CI 0.45–2.56; P = 0.87) between the standard-and high-dose groups. High and standard dosages of new generation of the PPIs showed similar H. pylori eradication rates and AEs as well as between Asian versus Caucasian populations, with or without clarithromycin-resistance. However, further studies are needed to confirm.

scholarly journals Helicobacter pylori eradication in patients with type 2 diabetes mellitus: Multicenter prospective observational study

2019 ◽  
Vol 7 ◽  
pp. 205031211983209 ◽  
Author(s):  
Seung-Joo Nam ◽  
Sung Chul Park ◽  
Sang Hoon Lee ◽  
Dong Wook Choi ◽  
Sung Joon Lee ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Eradication Rate ◽  
Laboratory Data ◽  
P Value ◽  
Diabetic Patients ◽  
Multicenter Prospective Observational Study ◽  
H Pylori

Objective: To compare Helicobacter pylori ( H. pylori) eradication rate of type 2 diabetic patients with non-diabetic subjects. Methods: In this multicenter prospective observational study, H. pylori-infected subjects were enrolled from three university-affiliated hospitals. Eradication regimen was triple therapy with standard dose of proton pump inhibitors (b.i.d), amoxicillin (1.0 g b.i.d), and clarithromycin (500 mg b.i.d) for 7 days. Urea breath test was performed 4 weeks after treatment. Various clinical and laboratory data were collected for identification of factors associated with successful eradication. Results: Totally, 144 subjects were enrolled and 119 (85 non-diabetic and 34 diabetic patients) were finally analyzed. Eradication rate was 75.6% and there was no difference between diabetic patients and non-diabetic subjects (73.5% vs 76.5%, p value: 0.814). Adverse drug reactions were reported in 44.5% of patients. In multivariate analysis for predicting H. pylori eradication in diabetic patients, HbA1c (⩾7.5%) was a significant factor affecting eradication rate (adjusted odds ratio: 0.100, 95% confidence interval: 0.011–0.909, p value: 0.041). Conclusion: Diabetes itself is not a major factor affecting H. pylori eradication. However, poor glucose control may harmfully affect H. pylori eradication.

scholarly journals Antibiotic Resistance of Helicobacter pylori Strains Isolated From Pediatric Patients in Southwest China

2021 ◽  
Vol 11 ◽  
Author(s):  
Juan Li ◽  
Jianjun Deng ◽  
Zhiling Wang ◽  
Hong Li ◽  
Chaomin Wan
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Pediatric Patients ◽  
Southwest China ◽  
Pediatric Population ◽  
Primary Resistance ◽  
Secondary Resistance ◽  
Treatment Naïve ◽  
H Pylori ◽  
Resistance Rates

The number of antibiotics that are appropriate for Helicobacter pylori eradication in children is limited. Profiling regional or population-specific antibiotic resistance is essential in guiding the H. pylori eradication treatment in children. The aim of this study was to evaluate the antibiotic resistance in H. pylori strains isolated from children and adolescents in Southwest China. Gastric biopsies from 157 pediatric patients with or without previous H. pylori eradication treatment were collected for H. pylori culture. Susceptibility to amoxicillin (AML), clarithromycin (CLR), metronidazole (MTZ), levofloxacin (LEV), tetracycline (TET), furazolidone (FZD), and rifampicin (RIF) was determined by E-test or a disk diffusion assay. A total of 87 patients from three ethnic groups (Han/Tibetan/Yi) were H. pylori culture positive (55.4%). The overall resistance rates were 55.2% for CLR, 71.3% for MTZ, 60.9% for RIF, and 18.4% for LEV. No isolate was found to be resistant to AML, TET, and FZD. Among the 53 treatment-naïve pediatric patients, primary resistance rates to clarithromycin, metronidazole, levofloxacin, and rifampicin were 45.3, 73.6, 15.1, and 60.4%, respectively. Among the 34 treatment-experienced patients, secondary resistance rates to clarithromycin, metronidazole, levofloxacin, and rifampicin were 70.6, 67.6, 23.5, and 61.8%, respectively. Isolates exhibiting simultaneous resistance to clarithromycin and metronidazole were 28.3 and 52.9% among the treatment-naïve and treatment-experienced patients, respectively. In conclusion, among pediatric patients in Southwest China, resistance rates were high for clarithromycin, metronidazole, levofloxacin, and rifampicin, whereas nil resistance was found to amoxicillin, tetracycline, and furazolidone. Our data suggest that the standard clarithromycin-based triple therapy should be abandoned as empiric therapy, whereas the bismuth quadruple therapy (bismuth/PPI/amoxicillin/tetracycline) would be suitable as first-line empiric treatment regimen for this pediatric population. Tetracycline and furazolidone may be considered for treating refractory H. pylori infections in adolescent patients.

scholarly journals Helicobacter pylori Eradication According to Sequencing-Based 23S Ribosomal RNA Point Mutation Associated with Clarithromycin Resistance

2019 ◽  
Vol 9 (1) ◽  
pp. 54 ◽  
Author(s):  
Seung In Seo ◽  
Byoung Joo Do ◽  
Jin Gu Kang ◽  
Hyoung Su Kim ◽  
Myoung Kuk Jang ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Point Mutation ◽  
Ribosomal Rna ◽  
Eradication Rate ◽  
Point Mutations ◽  
Clarithromycin Resistance ◽  
Clinically Significant ◽  
H Pylori ◽  
23S Ribosomal Rna ◽  
Significant Point

Background/Aims: Clarithromycin resistance in Helicobacter pylori is associated with point mutations in the 23S ribosomal RNA (rRNA) gene. We investigated the point mutations in the 23S rRNA genes of patients with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the point mutations. Methods: A total of 431 adult patients with H. pylori infection were recruited in Kangdong Sacred Heart Hospital in 2017 and 2018. Patients who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for seven days, while patients with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for seven days. H. pylori eradication rates were compared. Results: Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C). The clarithromycin resistance rate was 21.3% in the overall group of patients. A2143G was the most clinically significant point mutation (84/431, 19.5%), while T2182C was the most clinically insignificant point mutation (283/431, 65.7%). The overall H. pylori eradication rate was 83.7%, and the seven-day PAM-treated clarithromycin-resistance group showed a significantly lower eradication rate than the seven-day PAC-treated nonresistance group (ITT; 55.4% (51/92) vs. 74.3% (252/339), p = 0.001, PP; 66.2% (51/77) vs. 88.4% (252/285), p = 0.0001). Conclusions: There were significantly lower eradication rates in the patients with clarithromycin-resistant H. pylori when treated with PAM for seven days. A future study comparing treatment regimens in clarithromycin-resistant H. pylori-infected patients may be necessary.

Primary antibiotic resistance of Helicobacter pylori among a Chinese Tibetan population

2020 ◽  
Vol 15 (14) ◽  
pp. 1353-1361
Author(s):  
Xiaoqiong Tang ◽  
Xiaohong Chen ◽  
Yalin Shen ◽  
Tiankuo Yang ◽  
Renwei Hu ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Antibiotic Resistance ◽  
Primary Resistance ◽  
Tibetan Population ◽  
Disk Diffusion Assay ◽  
Treatment Naïve ◽  
Gastric Biopsies ◽  
H Pylori ◽  
Resistance Rates ◽  
Diffusion Assay

Aim: To evaluate the primary antibiotic resistance in Helicobacter pylori strains isolated from a Chinese Tibetan population. Methods & materials: Gastric biopsies from 400 H. pylori treatment-naive Tibetan patients were collected for H. pylori isolation. Susceptibility to amoxicillin (AML)/clarithromycin (CLR)/levofloxacin (LEV)/metronidazole (MTZ)/tetracycline (TET)/rifampicin (RIF)/furazolidone (FZD) was determined by E-test or a disk diffusion assay. Results: Biopsies from 117 patients were H. pylori culture positive (29.3%). The primary resistance rates to MTZ, CLR, LEV, RIF, AML, TET and FZD were 90.6, 44.4, 28.2, 69.2, 7.7, 0.8 and 0.8%, respectively. Interestingly, 42.7% of the strains had simultaneous resistance to CLR and MTZ. Conclusion: Among Tibetan strains, primary resistance rates were high for CLR/MTZ/LEV, whereas primary resistance rates to AML/TET/FZD were low. The high resistance to RIF is a concerning finding.

scholarly journals 1477. A Randomized Phase 2 Study of Cefepime Combined with the Novel Extended Spectrum β-Lactamase Inhibitor Enmetazobactam in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP)

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S539-S539
Author(s):  
Yehuda Carmeli ◽  
Philipp Knechtle ◽  
Jeff Hardenberg ◽  
Mathias Knecht
Keyword(s):  
Study Drug ◽  
Generation Cephalosporin ◽  
Double Blind Study ◽  
The Novel ◽  
Phase 2 ◽  
Double Blind ◽  
Extended Spectrum ◽  
Phase 2 Study ◽  
Dosing Regimens ◽  
Tract Infections

Abstract Background Third-generation cephalosporin (3GC)-resistant Enterobacteriaceae has been classified as critical priority pathogens. The novel extended-spectrum β-lactamase (ESBL) inhibitor enmetazobactam (formerly AAI101; EMT) in combination with cefepime (FEP) is currently being developed as a carbapenem-sparing treatment of serious Gram-negative infections in settings with a high prevalence of 3GC-resistant Enterobacteriaceae. We report here the results from a phase 2 study that assessed safety, tolerability, and pharmacokinetics of FEP-EMT in patients with cUTI/AP. Methods Forty-five patients were enrolled in a randomized, multicenter, double-blind study of hospitalized adults with cUTI/AP. Patients received dosing regimens of FEP or FEP-EMT IV therapy q8h by 2 hours infusion (table) for 7 to 10 days with a 28-day follow-up. Efficacy was evaluated in the microbiological-modified ITT (µMITT) population. Safety was monitored in patients who received at least 1 dose of study drug. Clinical cure was designated as the resolution of cUTI symptoms present at study entry. Plasma and urine PK were determined from all patients. Results The study drugs were well tolerated in each cohort, with similar % adverse events and no new or unexpected safety concerns (table). Two discontinuations were due to allergic dermatitis. The microbiological- and clinical responses at test-of-cure for the combined FEP-EMT group were 83.3% (20/24) and 95.8% (23/24) compared with responses in the combined FEP group of 73.3% (11/15) and 93.3% (14/15), respectively (table). The most common baseline pathogens were Escherichia coli (66.7%) and Klebsiella pneumoniae (23.1%): 28.2% of isolates produced ESBLs with eradication rates for the combined FEP-EMT group of 85.7% (6/7) and for the combined FEP group of 75.0% (3/4). FEP and EMT PK were best described by a 2-compartment, linear PK model. Both agents exhibited half-lives of 2.3 hours. Creatinine clearance had a significant covariate effect on FEP and EMT, consistent with predominant renal excretion of both agents. Conclusion Results from this phase 2 study justify advancement to phase 3 studies to evaluate the safety and efficacy of FEP-EMT in patients with cUTI/AP. Disclosures All authors: No reported disclosures.

Intravenous dexketoprofen vs placebo for migraine attack in the emergency department: A randomized, placebo-controlled trial

Cephalalgia ◽  
2015 ◽  
Vol 36 (2) ◽  
pp. 179-184 ◽  
Author(s):  
Faruk Gungor ◽  
Kamil Can Akyol ◽  
Mustafa Kesapli ◽  
Ahmet Celik ◽  
Adeviye Karaca ◽  
...  
Keyword(s):  
Emergency Department ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Study Drug ◽  
Final Analysis ◽  
Allocation Concealment ◽  
Double Blind Study ◽  
Care Hospital ◽  
Double Blind ◽  
Migraine Headaches

Objective Migraine is a leading headache etiology that frequently presents to the emergency department (ED). In the present study, we aimed to determine the efficacy of dexketoprofen in aborting migraine headaches in the ED. Methods This prospective, randomized, double-blind study was conducted in an ED of a tertiary care hospital using allocation concealment. Patients were allocated into two arms to receive the study drug; 50 mg dexketoprofen in 50 ml saline and 50 ml saline as placebo. Change in pain intensity was measured by the visual analog scale at baseline, both at 30 and 45 minutes after the study medication was administered. Rescue medication requirement and pain relapse were also recorded by a telephone follow-up at 48 hours. Results A total of 224 patients (112 in each group) were included into the final analysis. Mean age of the study participants was 37 ± 11 (SD) and 25% ( n = 56) of them were male. The median pain improvement at 45 minutes for patients receiving dexketoprofen was 55 (IQR: 49 to 60) and 30 (IQR: 25 to 35) for those receiving placebo. The mean difference between the two groups at 45 minutes was 21.4 (95% CI: 14.4. to 28.5). Rescue drugs were needed in 22.3% of patients who received dexketoprofen compared to 55.4% in patients who received placebo (dif: 33.1%; 95% CI: 20% to 45%). There were no adverse events reported in either group during the study period. Conclusion Intravenous dexketoprofen is superior to placebo in relieving migraine headaches in the ED. It may be a suitable therapy with minimum side effects in patients presenting with a migraine headache to the ED.

scholarly journals A 14-Day Course of Triple Therapy is Superior to a 10-Day Course for the Eradication ofHelicobacter pylori: A Canadian Study Conducted in a ‘Real World’ Setting

2015 ◽  
Vol 29 (8) ◽  
pp. e7-e10 ◽  
Author(s):  
Yen-I Chen ◽  
Carlo A Fallone
Keyword(s):  
Triple Therapy ◽  
Eradication Rate ◽  
Day Treatment ◽  
Office Visit ◽  
First Line ◽  
Intention To Treat ◽  
Treatment Naïve ◽  
Gastric Biopsies ◽  
H Pylori ◽  
Treat Analysis

BACKGROUND: SuccessfulHelicobacter pylorieradication with the traditional seven-day course of proton pump inhibitor (PPI) triple therapy is declining. Prolonging therapy to either 10 or 14 days is associated with better eradications rates.OBJECTIVE: To compare the effectiveness of 14-day course of triple therapy versus a 10-day course in the treatment ofH pyloriin Canada.METHODS: Consecutive treatment-naive patients with clinical indications forH pylorieradication underwent either a 10-day course or a 14-day course of traditional PPI triple therapy depending on the date of the office visit (an odd date received the 10-day course, whereas an even date received the 14-day treatment).H pylorieradication was ascertained via urea breath test or gastric biopsies performed ≥4 weeks after completion of therapy. Analyses were by both intention to treat and per-protocol.RESULTS: A total of 83 patients were included in the study (31 in the 10-day group and 52 in the 14-day group). In the intention-to-treat analysis, eradication rates were 82.7% (95% CI 70% to 92%) versus 45.2% (95% CI 27% to 64%), favouring the 14-day treatment (P<0.001). Similarly, in the per-protocol analysis, eradication rates were 91.5% (95% CI 80% to 98%) versus 63.6% (95% CI 41% to 83%), favouring the 14-day arm (P=0.01). Adverse events and compliance were not significantly different between the two groups.CONCLUSION: A 14-day course of standard PPI triple therapy was superior to a shorter-duration therapy and should be included as a first-line regimen forH pylorieradication in Canada. The 10-day course of treatment did not achieve an acceptable eradication rate and should no longer be used in this country.

scholarly journals The Efficacy of Washed Microbiota Transplantation on Helicobacter pylori Eradication: A Pilot Study

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Zhi-Ning Ye ◽  
Harry Hua-Xiang Xia ◽  
Ran Zhang ◽  
Lan Li ◽  
Li-Hao Wu ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Gastrointestinal Tract ◽  
Pilot Study ◽  
Therapeutic Effect ◽  
Eradication Rate ◽  
Clinical Factors ◽  
Helicobacter Pylori Eradication ◽  
Significant Difference ◽  
Delivery Route ◽  
H Pylori

Aim. The fecal microbiota transplantation by washed preparation was recently coined as washed microbiota transplantation (WMT). This pilot study is aimed at exploring the feasibility and efficacy of WMT on Helicobacter pylori eradication. Methods. Consecutive patients who had been treated with WMT for various indications and who were positive for H. pylori infection before WMT treatment but had never received eradication therapy for H. pylori infection were invited to take a follow-up 13C-urea breath test. The associations of demographic, clinical factors, and laboratory indicators for gastric function and intestinal barrier function with the therapeutic effect were determined. Results. A total of 32 eligible patients were included, and the overall H. pylori eradication rate was 40.6% (13/32). Patients with H. pylori eradication had a higher pepsinogen ratio (PGR) than those without ( 13.00 ± 6.97 vs. 8.31 ± 3.733 ; P = 0.02 ). Female patients had a higher, albeit not statistically significant, eradication rate than male patients (53.85% vs. 31.58%; P = 0.208 ). Compared with lower gastrointestinal tract delivery route, middle gastrointestinal tract delivery route seems to be a more suitable way for the treatment of H. pylori infection (58.33% vs 16.67%; P = 0.152 ). There was no significant difference in other demographic and clinical factors between patients with and without H. pylori eradication. Conclusion. H. pylori infection is eradicated in a proportion of patients who have received WMT. An increased pre-WMT PGR appears to be associated with the therapeutic effect. Further studies are required to confirm the efficacy of WMT, especially in combination with currently recommended regimens in randomized controlled trials.

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