scholarly journals Randomized Clinical Trial Comparing Concomitant and Tailored Therapy for Eradication of Helicobacter pylori Infection

2021 ◽  
Vol 11 (6) ◽  
pp. 534
Author(s):  
Nikola Perkovic ◽  
Antonio Mestrovic ◽  
Josko Bozic ◽  
Mirela Pavicic Ivelja ◽  
Jonatan Vukovic ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Primary Objective ◽  
First Line ◽  
Tailored Therapy ◽  
Open Label ◽  
Intention To Treat ◽  
Clarithromycin Resistance ◽  
Reasonable Choice ◽  
H Pylori

As high clarithromycin resistance (>20%) in the Split-Dalmatia region of Croatia hinders the treatment of H. pylori infection, the primary objective of this study was to compare concomitant quadruple with the tailored, personalized therapy as first-line eradication treatment of H. pylori. In an open-label, randomized clinical trial, 80 patients with H. pylori infection were randomly assigned to either concomitant (esomeprazole 40 mg, amoxicillin 1 gr, metronidazole 500 mg, clarithromycin 500 mg, twice daily for 14 days) or tailored therapy in accordance with the results of the antimicrobial susceptibility testing. Eradication status was assessed 4 weeks after treatment. Eradication rates were significantly higher in tailored group than in concomitant group both in intention-to-treat (70 vs. 92.5%, p = 0.010) and per-protocol (87.5 vs. 100%, p = 0.030) analysis in the setting of increasing antibiotic resistance (clarithromycin 37.5%, metronidazole 17.5%, dual resistance 10%). Adverse effects were more frequent in the concomitant group (32.5 vs. 7.5%, p = 0.006). Tailored therapy achieves higher eradication with a lower adverse events rate. With the increasing resistance of H. pylori strains to antibiotic treatment, eradication regimes with such characteristics should be strongly considered as a reasonable choice for first-line treatment.

Phase III randomized sequential open-label study to evaluate the efficacy of FOLFOX + panitumumab followed by FOLFIRI + bevacizumab (Sequence 1) versus FOLFOX+ bevacizumab followed by FOLFIRI + panitumumab (Sequence 2) in untreated patients with wild-type RAS metastatic, primary left (L)-sided, unresectable colorectal cancer (CRC): The CR-SEQUENCE.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS3618-TPS3618
Author(s):  
Ramon Salazar ◽  
Alfredo Carrato ◽  
Teresa Garcia Garcia ◽  
Javier Gallego Plazas ◽  
Auxiliadora Gómez-España ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Objective Response ◽  
Primary Objective ◽  
Phase Iii ◽  
Second Line ◽  
Wild Type ◽  
First Line ◽  
Open Label ◽  
Anti Vegf

TPS3618 Background: Both anti-EGFR and anti-VEGF therapies have shown clinical benefit when they are added in first and second-line in L-sided CRC. The conflicting results in anti-VEGF vs. anti-EGFR studies (FIRE-3, PEAK and CALGB/SWOG 80405 studies) suggest that the sequence of targeted therapies added to FOLFOX or FOLFIRI regimens in first- and second-line treatment could be an important factor in the overall survival (OS) of mCRC patients. Currently, there are no randomized data on the sequential use of an anti-EGFR followed by an anti-VEGF or vice versa. Therefore, the aim of this randomized clinical trial is to compare the efficacy of two treatment sequences, panitumumab followed by bevacizumab versus bevacizumab followed by panitumumab in combination with FOLFOX chemotherapy in first-line and with FOLFIRI in second-line in patients with wild-type RAS, primary L-sided, metastatic colorectal cancer (mCRC). Methods: A phase III, multicentre, open-label and randomized two-arm clinical trial. Untreated patients with wild-type RAS mCRC (determined locally), primary L-sided and unresectable will be screened for this trial. Eligible patients will be randomized 1:1 to receive first-line (1L) panitumumab plus FOLFOX and then bevacizumab plus FOLFIRI as second-line (2L) treatment (Seq. 1) or bevacizumab plus FOLFOX as 1L and then panitumumab plus FOLFIRI as 2L treatment (Seq. 2). Randomization will be stratified by number of metastatic organs involved (1 vs > 1). Primary objective is the comparison of the progression free survival (PFS) rate at 35 months (m) of Seq 1 vs Seq. 2. Secondary objectives: PFS from randomization to 2nd progression or death, OS rate at 35 months and OS of Seq. 1 vs Seq. 2; PFS, objective response rate, disease control rate, early tumour shrinkage, Depth of Response, duration and time to response and safety in 1L treatment and in 2L treatment in each Sequence arm. Exploratory objectives: impact of baseline biomarkers predictive of the efficacy in each Sequence arm and the clinical impact of clonal dynamics by longitudinal analysis of circulating tumour deoxyribonucleic acid (ctDNA) in plasma. The trial is in progress; 28 of up to 370 planned patients have been recruited at the end of January 2019 (first patient in 31 October 2018). Clinical trial information: NCT03635021.

scholarly journals Comparison of the effect of clarithromycin triple therapy with or without N-acetylcysteine in the eradication of Helicobacter pylori: a randomized controlled trial

2020 ◽  
Vol 13 ◽  
pp. 175628482092730
Author(s):  
Chieh-Chang Chen ◽  
Jiing-Chyuan Luo ◽  
Yu-Jen Fang ◽  
Ji-Yuh Lee ◽  
Chia-Chi Kuo ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Triple Therapy ◽  
Controlled Trial ◽  
Line Treatment ◽  
First Line ◽  
Open Label ◽  
Intention To Treat ◽  
Cyp2c19 Polymorphism ◽  
H Pylori ◽  
First Line Treatment

Background: Whether adjunctive N-acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of Helicobacter pylori infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of H. pylori. Material and methods: Between 1 January 2014 and 30 June 2018, 680 patients with H. pylori infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC [NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d.] for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and CYP2C19 gene polymorphism were determined. Results: The ITT analysis demonstrated H. pylori eradication rates in NAC-T14 and T14 were 81.7% [276/338, 95% confidence interval (CI): 77.5–85.8%] and 84.3% (285/338, 95% CI 80.4–88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by CYP2C19 polymorphism. Conclusion: Add-on NAC to triple therapy was not superior to triple therapy alone for first-line H. pylori eradication [ClinicalTrials.gov identifier: NCT02249546].

scholarly journals Bismuth Containing Quadruple Therapy versus Tailored Therapy as first-line treatments for Helicobacter pylori infection in a high clarithromycin resistance area

2019 ◽  
Author(s):  
Byoung Wook Bang ◽  
Jong Beom Shin ◽  
Eun Jung Ko ◽  
Kye Sook Kwon ◽  
Yong Woon Shin ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Cost Effective ◽  
Medical Costs ◽  
Rapid Urease Test ◽  
First Line ◽  
Tailored Therapy ◽  
Quadruple Therapy ◽  
Clarithromycin Resistance ◽  
Urease Test ◽  
H Pylori

Abstract Background Increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) in Korea, and bismuth containing quadruple therapy (BQT) and tailored therapy (TT) have been proposed as alternative regimens. The aim of this study was to compare the eradication rates of BQT and TT as first-line H. pylori eradication therapies. Methods H. pylori infection was diagnosed using the rapid urease test or dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) during endoscopy. Patients positive for H. pylori were divided into two groups; those tested using the rapid urease test received empirical BQT (the BQT group) whereas those tested by DPO-PCR received TT (the TT group). Eradication rates, adverse events, and overall medical costs, which included diagnostic test and eradication regimen costs, were compared. Results Three hundred and sixty patients were included in the study (TT group 178, BQT group 182). The modified intention-to-treat eradication rates of BQT and TT were 88.2% (142/161) and 80.3% (118/147), respectively (p=0.055), and corresponding eradication rates in the per-protocol population were 88.8% (142/160) and 81.4% (118/145) (p=0.07). Compliance and adverse event rates were similar in the two groups. Average medical costs were $ 90.3 per patient in the TT group and $ 75.5 in the BQT group (p=0.000). Conclusions Empirical BQT and tailored therapy were similar in terms of H. pylori eradication rate, safety, and tolerability, but BQT was more cost-effective.

scholarly journals Bismuth Containing Quadruple Therapy versus Tailored Therapy as first-line treatments for Helicobacter pylori infection in a high clarithromycin resistance area

2019 ◽  
Author(s):  
Byoung Wook Bang ◽  
Jong Beom Shin ◽  
Eun Jung Ko ◽  
Kye Sook Kwon ◽  
Yong Woon Shin ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Cost Effective ◽  
Medical Costs ◽  
Rapid Urease Test ◽  
First Line ◽  
Tailored Therapy ◽  
Quadruple Therapy ◽  
Clarithromycin Resistance ◽  
Urease Test ◽  
H Pylori

Abstract Background Increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) in Korea, and bismuth containing quadruple therapy (BQT) and tailored therapy (TT) have been proposed as alternative regimens. The aim of this study was to compare the eradication rates of BQT and TT as first-line H. pylori eradication therapies. Methods H. pylori infection was diagnosed using the rapid urease test or dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) during endoscopy. Patients positive for H. pylori were divided into two groups; those tested using the rapid urease test received empirical BQT (the BQT group) whereas those tested by DPO-PCR received TT (the TT group). Eradication rates, adverse events, and overall medical costs, which included diagnostic test and eradication regimen costs, were compared. Results Three hundred and sixty patients were included in the study (TT group 178, BQT group 182). The modified intention-to-treat eradication rates of BQT and TT were 88.2% (142/161) and 80.3% (118/147), respectively (p=0.055), and corresponding eradication rates in the per-protocol population were 88.8% (142/160) and 81.4% (118/145) (p=0.07). Compliance and adverse event rates were similar in the two groups. Average medical costs were $ 90.3 per patient in the TT group and $ 75.5 in the BQT group (p=0.000). Conclusions Empirical BQT and tailored therapy were similar in terms of H. pylori eradication rate, safety, and tolerability, but BQT was more cost-effective.

EFFICACY OF 10 - DAY LEVOFLOXACIN CONTAINING SEQUENTIAL THERAPY IN PATIENTS WITH HELICOBACTER PYLORI–ASSOCIATED CHRONIC GASTRITIS

2017 ◽  
pp. 14-21
Author(s):  
Phan Hong Ngoc Nguyen ◽  
Van Huy Tran
Keyword(s):  
Side Effects ◽  
Clinical Symptoms ◽  
Sequential Therapy ◽  
First Line ◽  
Intention To Treat ◽  
Clarithromycin Resistance ◽  
Central Vietnam ◽  
Urease Test ◽  
High Prevalence ◽  
H Pylori

Background: The increasing of antibiotic resistance in H. pylori has become a main cause for treatment failure. A 10-day levofloxacin containing sequential therapy is efficient and safe in eradication H. pylori infection in an area with high prevalence of clarithromycin resistance. Aims: To evaluate the efficacy of 10day levofloxacin containing sequential therapy as first-line treatment for H. pylori eradication, side effects, symptoms and endoscopic responses and improvement of histological features in Centre Vietnam. Patients and methods: 120 Naïve H. pylori positive patients were received levofloxacin containing sequential therapy (rabeprazole 20mg twice daily, amoxicillin 1g twice daily for 5 days followed by rabeprazole 20mg, levofloxacin 500mg, and tinidazole 500mg, twice daily for 5 more days). These patients tested positive for H. pylori by urease test and gastric mucosal biopsy presented mononuclear cell infiltrating in lamina propria. Results: Intention to treat (ITT) eradication rates of RA-RLT was 73.5%. Per protocol (PP) eradication rates were 81.5%. Overall, 33.7% experienced mild to moderate adverse events. No patient stopped the treatment because of side effects. 6 months after H. pylori eradication clinical symptoms and only edema undergoing endoscopy significantly improved. Grade of activity inflammation and stage of gastritis significantly decreased at 6 months. Intestinal metaplasia and dysplasia did not change significantly at 6 months. Conclusion: 10day levofloxacin containing sequential therapy may be considered as one of the first choices in H. pylori eradication in Central Vietnam. H. pylori eradication may improve clinical symptoms, inflammative activity and stage of gastritis in histology. Key words: H. pylori, gastritis, levofloxacin

scholarly journals Sequential Therapy for First-Line Helicobacter pylori Eradication: 10- or 14-Day Regimen?

2019 ◽  
Vol 28 (1) ◽  
pp. 11-14 ◽  
Author(s):  
Angelo Zullo ◽  
Giulia Fiorini ◽  
Giuseppe Scaccianoce ◽  
Piero Portincasa ◽  
Vincenzo De Francesco ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Previous Treatment ◽  
Sequential Therapy ◽  
Bacterial Eradication ◽  
First Line ◽  
Open Label ◽  
Intention To Treat ◽  
First Line Therapy ◽  
13C Urea Breath Test ◽  
H Pylori

Background & Aim: Standard 10-day sequential therapy is advised as first-line therapy for Helicobacter pylori (H. pylori) eradication by current Italian guidelines. Some data suggested that a 14-day regimen may achieve higher eradication rates. This study compared the efficacy of sequential therapy administered for either 10- or 14-days.Methods: This prospective, multicenter, open-label study enrolled patients with H. pylori infection without previous treatment. Patients were receiving a sequential therapy for either 10 or 14 days with esomeprazole 40 mg and amoxicillin 1 g (5 or 7 days) followed by esomeprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg (5 or 7 days), all given twice daily. Bacterial eradication was checked using 13C-urea breath test. Eradication cure rates were calculated at both Intention-to-treat (ITT) and per-protocol (PP) analyses.Results: A total of 291 patients were enrolled, including 146 patients in 10-day and 145 in the 14-day regimen. The eradication rates were 87% (95% CI = 81.5-92.4) and 90.3% (95% CI = 85.5-95.1) at ITT analysis with the 10- and 14-day regimen, respectively, and 92.7% (95% CI = 88.3-97) and 97% (95% CI = 94.2-99.9) at PP analysis (p =0.37). Among patients, who earlier had interrupted therapy, bacterial eradication was achieved in 8 out of 9 who completed the first therapy phase and performed at least ≥3 days of triple therapy in the second phase.Conclusion: This study found that both 10- and 14-day sequential therapies achieved a high eradication rate for first-line H. pylori therapy in clinical practice.

scholarly journals Bismuth Containing Quadruple Therapy versus Tailored Therapy as first-line treatments for Helicobacter pylori infection in a high clarithromycin resistance area

2019 ◽  
Author(s):  
Byoung Wook Bang ◽  
Jong Beom Shin ◽  
Eun Jung Ko ◽  
Kye Sook Kwon ◽  
Yong Woon Shin ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Cost Effective ◽  
Medical Costs ◽  
Rapid Urease Test ◽  
First Line ◽  
Tailored Therapy ◽  
Quadruple Therapy ◽  
Clarithromycin Resistance ◽  
Urease Test ◽  
H Pylori

Abstract Background Increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) in Korea, and bismuth containing quadruple therapy (BQT) and tailored therapy (TT) have been proposed as alternative regimens. The aim of this study was to compare the eradication rates of BQT and TT as first-line H. pylori eradication therapies. Methods H. pylori infection was diagnosed using the rapid urease test or dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) during endoscopy. Patients positive for H. pylori were divided into two groups; those tested using the rapid urease test received empirical BQT (the BQT group) whereas those tested by DPO-PCR received TT (the TT group). Eradication rates, adverse events, and overall medical costs, which included diagnostic test and eradication regimen costs, were compared. Results Three hundred and sixty patients were included in the study (TT group 178, BQT group 182). The modified intention-to-treat eradication rates of BQT and TT were 88.2% (142/161) and 80.3% (118/147), respectively (p=0.055), and corresponding eradication rates in the per-protocol population were 88.8% (142/160) and 81.4% (118/145) (p=0.07). Compliance and adverse event rates were similar in the two groups. Average medical costs were $ 90.3 per patient in the TT group and $ 75.5 in the BQT group (p=0.000). Conclusions Empirical BQT and tailored therapy were similar in terms of H. pylori eradication rate, safety, and tolerability, but BQT was more cost-effective.

scholarly journals Seven-Day Nonbismuth Containing Quadruple Therapy Could Achieve a Grade “A” Success Rate for First-LineHelicobacter pyloriEradication

2015 ◽  
Vol 2015 ◽  
pp. 1-7 ◽  
Author(s):  
Wei-Chen Tai ◽  
Chih-Ming Liang ◽  
Chen-Hsiang Lee ◽  
Chien-Hua Chiu ◽  
Ming-Luen Hu ◽  
...  
Keyword(s):  
Therapy Group ◽  
Influential Factor ◽  
Clinical Factors ◽  
First Line ◽  
Quadruple Therapy ◽  
Intention To Treat ◽  
Factors Influencing ◽  
Clarithromycin Resistance ◽  
Metronidazole Resistance ◽  
H Pylori

This prospective study was to assess the efficacy of nonbismuth containing quadruple therapy as first-lineH. pyloritreatment and to determine the clinical factors influencing patient outcome. We enrolled 200H. pylori-infected naïve patients. They were prescribed either a 7-day nonbismuth containing quadruple therapy group (EACM, esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, metronidazole 500 mg twice daily, and clarithromycin 500 mg twice daily) or a 7-day standard triple therapy group (EAC, esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, and clarithromycin 500 mg twice daily). Follow-up studies to assess treatment responses were carried out 8 weeks later. The eradication rates attained by EACM and EAC groups were 95.6% (95% confidence interval [CI] = 89.4%–98.3%) and 79.3% (95% CI = 70%–86.4%) in the per-protocol analysis (P< 0.001) and 88% (95% CI = 80.2%–93.0%) and 73% (95% I = 63.6%–80.3%) in the intention-to-treat analysis (P= 0.007). Clarithromycin resistance, metronidazole resistance, and dual clarithromycin and metronidazole resistances were the clinical factors influencingH. pylorieradication in EACM group. Clarithromycin resistance and dual clarithromycin and metronidazole resistances were the influential factor for EAC treatment. In conclusion, the results suggest that 7-day nonbismuth containing quadruple therapy could achieve a grade “A” report card for first-lineH. pyloritreatment.

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