<i>Helicobacter pylori</i> from Peptic Ulcer Patients in Uganda Is Highly Resistant to Clarithromycin and Fluoroquinolones: Results of the GenoType HelicoDR Test Directly Applied on Stool

BackgroundThe 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.MethodsConsecutive 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.ResultsOf 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).ConclusionsRegardless 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.

show abstract

“…These limitations could have been avoided by using noninvasive determination methods (e.g. based on fecal specimens) [ 40 ].…”

Section: Discussionmentioning

confidence: 99%

Seven-day genotypic resistance-guided triple Helicobacter pylori eradication therapy can be highly effective

Papastergiou¹,

Mathou²,

Licousi

et al. 2017

aog

View full text Add to dashboard Cite

show abstract

“…Several attempts to develop methods for the detection of clarithromycin resistance with noninvasive sampling (stool sampling, for example) have been reported, but their performances were not sufficient for use in the clinical management of patients. Moreover, either the performances of these tests were poor or the tests were tested on a small cohort, limiting the quality of their evaluation (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25).…”

mentioning

confidence: 99%

Diagnostic Accuracy of a Noninvasive Test for Detection of Helicobacter pylori and Resistance to Clarithromycin in Stool by the Amplidiag H. pylori+ClariR Real-Time PCR Assay

et al. 2020

View full text Add to dashboard Cite

The noninvasive detection of Helicobacter pylori and its resistance to clarithromycin could revolutionize the management of H. pylori-infected patients by tailoring eradication treatment without any need for endoscopy when histology is not necessary. Several real-time PCR tests performed on stools have been proposed, but their performances were either poor or they were tested on too few patients to be properly evaluated. We conducted a prospective, multicenter study including 1,200 adult patients who were addressed for gastroduodenal endoscopy with gastric biopsies and who were naive for eradication treatment in order to evaluate the performance of the Amplidiag H. pylori+ClariR assay recently developed by Mobidiag (Espoo, Finland). The results of the Amplidiag H. pylori+ClariR assay performed on DNA from stools (automatic extraction with the EasyMag system [bioMérieux]) were compared with those of culture/Etest and quadruplex real-time PCRs performed on two gastric biopsy samples (from the antrum and corpus) to detect the H. pylori glmM gene and mutations in the 23S rRNA genes conferring clarithromycin resistance. The sensitivity and specificity of the detection of H. pylori were 96.3% (95% confidence interval [CI], 92 to 98%) and 98.7% (95% CI, 97 to 99%), respectively. The positive and negative predictive values were evaluated to be 92.2% (95% CI, 92 to 98%) and 99.3% (95% CI, 98 to 99%), respectively. In this cohort, 160 patients (14.7%) were found to be infected (positive by culture and/or PCR). The sensitivity and specificity for detecting resistance to clarithromycin were 100% (95% CI, 88 to 100%) and 98.4% (95% CI, 94 to 99%), respectively.

show abstract

“…This study had several limitations. Rates of antibiotic resistance within this region were not determined 23,52 . Given limited endoscopic and diagnostic resources within the Namutumba district, the prevalence of underlying gastric pre-neoplastic lesions was not assessed in H. pylori-positive residents.…”

Section: Discussionmentioning

confidence: 99%

Population-Based Screening and Eradication of Helicobacter pylori in a Resource-Limited Population of Sub-Saharan Africa

Lee

Ssekalo²,

Kazungu³

et al. 2020

Preprint

View full text Add to dashboard Cite

Background: Helicobacter pylori (H. pylori) infection is a common cause of chronic dyspepsia worldwide. Its prevalence in the developing world remains understudied, however. Given that H. pylori is the most significant risk factor for developing gastric cancer, an accurate assessment of the effectiveness of population-based screening and eradication of H. pylori is warranted. The objectives of this study were to determine the prevalence of H. pylori, to identify risk factors associated with H. pylori colonization, and to assess the efficacy of triple therapy on H. pylori eradication within a region of sub-Saharan Africa.Methods: We administered a dyspepsia questionnaire to 376 randomly selected adult residents of the Namutumba District in Uganda. Participants submitted a stool sample for H. pylori fecal antigen testing. H. pylori-positive participants were given standard triple therapy. The efficacy of triple therapy on H. pylori eradication was established by fecal H. pylori antigen testing and improvement in dyspepsia scores after treatment. Dyspeptic, H. pylori-negative participants were administered daily omeprazole for one month. Logistic regression analyses were used to identify factors associated with H. pylori positivity, chronic dyspepsia, and H. pylori eradication failure.Results: The prevalence of H. pylori within the study population was 48%. A higher level of education was significantly associated with H. pylori positivity. 87% of study participants reported at least one symptom of dyspepsia, with 43% reporting moderate or severe dyspepsia. Dyspepsia severity was independent of H. pylori status. Standard triple therapy resulted in ~90% eradication. Missing four or more doses of the triple therapy regimen was significantly associated with H. pylori eradication failure.Conclusions: Chronic dyspepsia is a common complaint in this sub-Saharan population but is not by itself a defining feature of H. pylori positivity. Clinical suspicion for H. pylori within this population should nonetheless remain high, given the high prevalence of positivity among all those with dyspepsia, including many with relatively mild dyspeptic symptoms. Population-based screening and adherence to standard triple therapy are effective at eradicating H. pylori within this region. Trial Registration: This study was registered in ClinicalTrials.gov (TRN: NCT04525664, registered 24 August 2020 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04525664). This study adheres to CONSORT guidelines.

show abstract

Helicobacter pylori from Peptic Ulcer Patients in Uganda Is Highly Resistant to Clarithromycin and Fluoroquinolones: Results of the GenoType HelicoDR Test Directly Applied on Stool

Cited by 13 publications

References 36 publications

Seven-day genotypic resistance-guided triple Helicobacter pylori eradication therapy can be highly effective

Seven-day genotypic resistance-guided triple Helicobacter pylori eradication therapy can be highly effective

Diagnostic Accuracy of a Noninvasive Test for Detection of Helicobacter pylori and Resistance to Clarithromycin in Stool by the Amplidiag H. pylori+ClariR Real-Time PCR Assay

Population-Based Screening and Eradication of Helicobacter pylori in a Resource-Limited Population of Sub-Saharan Africa

Contact Info

Product

Resources

About