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Pilot study: Comparing efficacy of 14-day triple therapy Clarithromycin versus levofloxacin on eradication of Helicobacter pylori infection in Syrian population single-center experience.

ABSTRACT: Context:Goals: To compare the efficacy of standard triple therapy with clarithromycin versus triple therapy with levofloxacin for treatment of Helicobacter pylori-positive infection in a referral hospital in Damascus, Syria. Design:pilot prospective open-label randomized controlled trial. Subjects and Methods:Eighty treatment-naive patients who tested positive for H. pylori gastric infection were randomly assigned to one of two treatment groups with randomization ratio of 50/50. Group (A) was treated with clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg), each twice/day for 14 days, while Group (B) was treated with levofloxacin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg), each twice/day for 14 days.[1] After 6 weeks of treatment, all patients underwent endoscopy and biopsy to evaluate H. pylori infection eradication. Results:Forty patients were allocated in each group; 37 patients completed the follow-up in each group. Thirteen patients in Group (A) were cured, with an eradication rate of 35.1% according to per-protocol analysis (PPA) and 32.5% according to intention-to-treat analysis (ITT), while in Group (B), 11 patients were cured, with an eradication rate of 29.7% according to PPA and 27.5% according to ITT with P = 0.80. No serious adverse events reported in both the groups. Conclusions:Clarithromycin is slightly better than levofloxacin in treatment of H. pylori gastric infection, but both regimens show low effectiveness with suboptimal eradication rates in our selected population.

SUBMITTER: Cheha KM

PROVIDER: S-EPMC5782415 | biostudies-literature | 2018 Jan-Mar

REPOSITORIES: biostudies-literature

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Pilot study: Comparing efficacy of 14-day triple therapy Clarithromycin versus levofloxacin on eradication of <i>Helicobacter pylori</i> infection in Syrian population single-center experience.

Cheha Khaled Mohammad KM Dib Sawsan Omar Ali SOA Alhalabi Marouf Mohammad MM

Avicenna journal of medicine 20180101 1

<h4>Context</h4>Goals: To compare the efficacy of standard triple therapy with clarithromycin versus triple therapy with levofloxacin for treatment of <i>Helicobacter pylori</i>-positive infection in a referral hospital in Damascus, Syria.<h4>Design</h4>pilot prospective open-label randomized controlled trial.<h4>Subjects and methods</h4>Eighty treatment-naive patients who tested positive for <i>H. pylori</i> gastric infection were randomly assigned to one of two treatment groups with randomizat ...[more]

PMID: 29404268

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Project description:BACKGROUND Considering the importance of Helicobacter pylori (H. pylori) eradication, this clinical trial was designed to prospectively evaluate the efficacy of levofloxacin-based, sequential therapy in comparison with quadruple therapy for eradicating H. pylori. METHODS Overall 156 patients with dyspepsia and H. pylori infection were included in this study and were randomly allocated to either 10-day sequential therapy group (group A) to receive pantoprazole (40 mg twice daily), amoxicillin (1 gr twice daily), levofloxacin (500 mg twice daily), and tinidazole (500 mg twice daily) (PALT) or 14-day quadruple therapy group (group B) to receive pantoprazole, clarithromycin, bismuth subcitrate, and amoxicillin (PABC). At the end of the study the eradication rate in each group was assessed by urea breath test (UBT). RESULTS Age range of the participants was 18-65 years (average 36.9 years) and 50% of them (78 patients) were men. 78 patients were allocated to group A and 78 patients to groupe B. After antibiotic therapy, all the patients received acid suppression therapy with Proton Pump Inhibitor (PPI) for 4 weeks and then the eradication rate was confirmed by UBT (Heli FAN plus 13C, Germany). Before performing UBT, all the participants were requested to halt consumption of PPI for at least 1 week. During the treatment there was not any major complication but in group A (sequential therapy), two patients complained of minor complications including musculoskeletal pain. None of the patients in group B had any complaint or side effect. The rate of H. pylori eradication in group A was 78.2% (61 patients) while this rate in group B was 83.3% (65 patients) with no significant difference between the two groups (p = 0.42). In subgroup analysis, the rate of eradication among men in group A and B were 76.9% and 89.7%, respectively (p = 0.22) while the eradication rate among women were 79.4% and 76.9%, respectively (p = 1.00). CONCLUSION It seems that levofloxacin base sequential therapy does not have any advantage in comparison with quadruple regimen and until finding any more effective short course therapy for H. Pylori eradication; we encourage quadruple regimen to be used as the first line therapy.

Project description:Summary of Trial Design.Lengthy exposure to quinolone-containing triple therapy in Helicobacter pylori eradication leads to the development of drug resistance. Sequential therapy with a quinolone and metronidazole -containing regimen appears to be an effective treatment option. This randomized controlled trial aimed to compare the efficacy of 5-plus 5 days' levofloxacin and metronidazole-containing sequential therapy (EALM) with that of 10-day levofloxacin-containing triple therapy (EAL) in second-line H pylori eradication treatment.One hundred and sixty-four patients who had failed the H pylori eradication attempts using the standard triple therapy (proton pump inhibitor bid, clarithromycin 500?mg bid, amoxicillin 1?g bid?×?7 days) were randomly assigned to either an EALM therapy group (n?=?82; esomeprazole 40?mg bid and amoxicillin 1?g bid for 5 days, followed by esomeprazole 40?mg bid, levofloxacin 500?mg qd, and metronidazole 500?mg tid, for 5 days) or a 10-day EAL therapy group (n?=?82; levofloxacin 500?mg qd, amoxicillin 1?g bid, and esomeprazole 40?mg bid). One patient was lost to follow-up in each group. Follow-up for H pylori status was performed 4 to 8 weeks later.Eradication rates for the EALM and EAL groups were 90.2% (74/82, 95% confidence interval [CI]?=?83.7%-96.8%) and 80.5% (66/82, 95% CI?=?71.7%-89.2%, P?=?0.077) in the intention-to-treat analysis; and 91.4% (74/81, 95% CI?=?85.1%-97.6%) and 81.5% (66/81, 95% CI?=?72.8%-90.1%, P?=?0.067) in the per-protocol analysis. The adverse events for the EALM and EAL groups were 23.5% versus 11.1%, P?=?0.038 but were all very mild and were well tolerated except for 1 patient with poor compliance. The compliances were 98.8% and 100%, respectively, between the 2 groups. An antibiotic resistance to levofloxacin was the clinical factor influencing the efficacy of H. pylori eradication therapy in the EAL group, and dual resistance to levofloxacin and metronidazole in the EALM group.Levofloxacin and metronidazole-containing sequential therapy achieved a >90% eradication rate as a second-line H pylori therapy. Dual antibiotic resistance to levofloxacin and metronidazole was the clinical factor influencing the efficacy of H pylori eradication therapy in the sequential therapy (ClinicalTrials.gov number: NCT02596620).

Project description:Background:The efficacy and applicability of molecular testing to guide the selection of antibiotics in triple Helicobacter pylori (H. pylori) eradication regimens have not been reported. We tested a 7-day, genotypic resistance-guided triple H. pylori eradication therapy in a high-resistance setting. Methods:Consecutive dyspeptic patients with H. pylori infection were prospectively enrolled. Genotypic resistances to clarithromycin (23SrRNA mutations) and fluoroquinolones (gyrA mutations) were determined from gastric biopsy specimens using a commercially available molecular assay (GenoTypeâ HelicoDR). A tailored genotypic resistance-guided 7-day triple therapy comprised esomeprazole, amoxicillin, and either clarithromycin (wild-type 23SrRNA), levofloxacin (23SrRNA mutated/wild-type gyrA) or rifabutin (both 23SrRNA/gyrA mutated). H. pylori eradication was confirmed by 13C-urea breath test. Results:Of 148 subjects screened, 51 patients were enrolled (male/female: 27/24, mean age: 50.7±11.4 years, treatment-naïve/-experienced: 32/19). The molecular kit was easily implemented, allowing for rapid (within 24 h) and relatively inexpensive determination of H. pylori resistance (clarithromycin: 47.1%, fluoroquinolones: 15.7%, dual clarithromycin/fluoroquinolones: 7.8%). For patients who received clarithromycin-, levofloxacin- and rifabutin-containing triple therapy, the respective eradication rates were 24/27, 20/20, and 2/4 by intention-to-treat (ITT); and 24/24, 19/19 and 2/3 by per-protocol (PP) analysis. Overall eradication rates were 90.2% (95% confidence interval [CI] 77.8-96.3%) by ITT and 97.8% (95%CI 87-99.8%) by PP analysis, showing no significant difference between treatment-naïve and -experienced patients (ITT: 87.5% vs. 94.7%, P=0.64; PP: 96.4% vs. 100%, respectively, P=1.00). Conclusions:Regardless of prior treatment history, a genotypic resistance-guided 7-day triple therapy, based on a simple molecular assay, achieved a high H. pylori eradication rate.

Project description:BACKGROUND The effects of PPI are variable owing to the CYP2C19 polymorphisms. However, whether the polymorphisms could affect the Hp eradication efficacy of triple therapy is still not clear. The present study aimed to assess the effects of CYP2C19 gene polymorphisms on proton pump inhibitor (PPI), amoxicillin, and levofloxacin triple therapy for Helicobacter pylori (Hp) eradication. MATERIAL AND METHODS We randomly assigned 160 Hp-positive patients with chronic gastritis to 2 groups to receive either 20 mg bid omeprazole (OAL group, n=80) or 10 mg bid rabeprazole (RAL group, n=80), combined with 1000 mg bid amoxicillin and 500 mg qd levofloxacin. The 2 groups were treated for 10 days. The CYP2C19 genotypes included wild-type, M1 mutant gene (*2, the mutation of exon 5), and M2 mutant gene (*3, the mutation of exon 4) identified by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFIP). According to CYP2C19 genotype combinations, the patients were divided into extensive metabolizer (EM), intermediate metabolizer (IM), and poor metabolizer (PM) subgroups. The eradication efficacy of Hp was evaluated by 14C-UBT at 28 days after treatment. RESULTS The trial was completed by 155 patients. Hp eradication rates in OAL and RAL groups were 78.2% and 88.3%, respectively, on per-protocol (PP) analysis, indicating no significant difference (P>0.05). Regarding CYP2C19 genotypes, eradication rates of 60.7%, 84.2%, and 100% were obtained for EM, IM, and PM subgroups, respectively, of the OAL group. EM group eradication rates were significantly lower than IM and PM group values (P<0.05). In the RAL group, no such difference was observed (P>0.05). Hp eradication rates were significantly lower in the EM subgroup of the OAL group compared with that of the RAL group. CONCLUSIONS Hp eradication rates were higher in the RAL group than in OAL-treated patients. Interestingly, omeprazole-based therapy was significantly affected by the CYP2C19 genotype, unlike the rabeprazole-based therapy.

Dataset Information

Pilot study: Comparing efficacy of 14-day triple therapy Clarithromycin versus levofloxacin on eradication of Helicobacter pylori infection in Syrian population single-center experience.

Publications

Pilot study: Comparing efficacy of 14-day triple therapy Clarithromycin versus levofloxacin on eradication of <i>Helicobacter pylori</i> infection in Syrian population single-center experience.

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