The efficacy of clarithromycin versus levofoxacin-based regimens for H.pylori treatment in naïve patients after the COVID-19 pandemic misuse of antibiotics

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In a recent study published in BMC Infectious Diseasesresearchers examined the eradication rates of Helicobacter pylori use of levofloxacin and clarithromycin-based regimens in patients with prior therapy with coronavirus disease 2019 (COVID-19).

Study: Helicobacter pylori eradication rates using clarithromycin and levofloxacin based regimens in patients with prior COVID-19 treatment: a randomized clinical trial. Image credit: Liya Graphics/Shutterstock

Background

Helicobacter pylori (H. pylori) affects half of the world’s population. It is considered the primary organism responsible for chronic gastritis, various gastric cancers and peptic ulcer disease. It has also been linked to extra-intestinal disorders, such as iron-deficiency anemia resistant to treatment, vitamin B12 insufficiency, and immune thrombocytopenic purpura. H. pylori eradication rates may be affected by antibiotic use during the COVID-19 pandemic.

About the study

In the current study, researchers assessed the efficacy of clarithromycin compared to levofloxacin-based therapies for H. pylori treatment in antibiotic-naïve individuals after the COVID-19 pandemic.

The study included a randomized control trial conducted from March 21, 2021 to September 30, 2021, in which patients were recruited from the outpatient clinics of Alexandria University hospitals and patients were referred by physicians working in outpatient and inpatient settings. Eligible participants were patients between 18 and 65 years of age who were recently diagnosed H. pylori infection and had previously been treated for COVID-19. The diagnosis was made according to a positive H. pylori stool antigen, rapid urease test, urea breath test or H. pylori detection during the histological analysis of gastric biopsies.

The test was conducted on subjects with either a peptic ulcer, a history of a peptic ulcer, a history or presence of stomach cancer, dyspepsia, chronic use of aspirin or pain medications, and a history of endoscopy to diagnose upper gastrointestinal (GI) symptoms to judge. The primary complaint of each patient was recorded. The first group was treated with amoxicillin, clarithromycin and esomeprazole, while the second group received esomeprazole, levofloxacin and amoxicillin.

All patients received extensive historical data, including demographic information and social history of alcohol or smoking use, as well as extensive clinical and laboratory investigations. Patient compliance was estimated by counting the remaining tablets at predetermined intervals. All patients were required to complete a drug side effect questionnaire. The severity of each symptom was rated between absent (0) and severe (3). After six to eight weeks of treatment, at least four weeks after discontinuing antimicrobials, and at least two weeks without PPI administration, the team evaluated H. pylori eradication.

Results

The study involved a total of 270 participants, including 135 individuals in each arm. Nearly 19 patients from the clarithromycin cohort and 18 patients from the levofloxacin cohort discontinued treatment within 2 to 4 days due to adverse outcomes or could no longer be followed prior to the evaluation of H. pylori extermination. Subsequently, 116 participants from the clarithromycin cohort and 117 participants from the levofloxacin group were evaluated.

The mean age of participants was 41.9 ± 13.0 years and included 58.8% male, 63.4% married, 88.0% residents of metropolitan areas, and 60.1% had no history of chronic conditions. The rest of the patients showed a treatment adherence of more than 80%. The team found no statistically significant difference between the levofloxacin and clarithromycin-based regimens in terms of baseline characteristics, primary complaint and diagnostic test used. Almost 25.5% of the patients studied smoked, while none of them reported drinking alcohol.

The whole H. pylori eradication response was 69.53%. The intention-to-treat (ITT) and per-protocol (PP) analyzes showed that patients treated with the levofloxacin-based regimen had treatment response rates of 64.44% and 74.36%. In comparison, those treated with the clarithromycin-based regimen had a response to treatment of 55.6% and 64.66%, respectively. However, these differences had no statistical significance. In addition, the team noted no statistically significant variation between the side effects reported by the two treatment groups.

Conclusion

The study findings showed that among participants with a history of previous COVID-19 treatment, both levofloxacin and clarithromycin-based regimens resulted in lower than acceptable eradication rates.

The researchers believe that this finding should be cause for concern regarding the increase in antibiotic resistance in these individuals and the population. This indicated that the growing resistance could have a negative impact H. pylori treatment costs and increase the risk of H. pylori-related diseases.

Explain the precise mechanism of antibiotic resistance H. pylori additional investigations are necessary in such patients. In light of the increasing prevalence of antibiotic resistance, this research can help policymakers determine the most cost-effective approach H. pylori therapy.

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