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Susceptibility‐guided therapy for Helicobacter pylori ‐infected penicillin‐allergic patients: A prospective clinical trial of first‐line and rescue therapies
Author(s) -
Luo Laisheng,
Huang Yu,
Liang Xiao,
Ji Yingjie,
Yu Lou,
Lu Hong
Publication year - 2020
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1111/hel.12699
Subject(s) - metronidazole , medicine , levofloxacin , clarithromycin , helicobacter pylori , penicillin , tolerability , antibiotics , gastroenterology , adverse effect , microbiology and biotechnology , biology
Background Helicobacter pylori ( H pylori ) treatment remains a challenge for penicillin‐allergic patients. Aim To evaluate the efficacy and tolerability of susceptibility‐guided first‐line and rescue treatment in H pylori ‐infected penicillin‐allergic patients. Methods Consecutive H pylori ‐infected patients with penicillin allergy received a 14‐day triple or quadruple therapy based on susceptibility to clarithromycin, levofloxacin, and metronidazole. All received esomeprazole 20 mg twice a day. Metronidazole‐susceptible infections received metronidazole plus clarithromycin or levofloxacin triple therapy if susceptible. Clarithromycin‐ and levofloxacin‐resistant infections received metronidazole plus tetracycline triple therapy. Metronidazole‐resistant infections received a bismuth—high‐dose metronidazole plus clarithromycin or levofloxacin quadruple therapy. Triple‐resistant infections received classical bismuth quadruple therapy with high‐dose metronidazole. Antimicrobial susceptibility was assessed using the E test method. Results 112 patients were entered (34.8% men, average 47.1 years). Infections in 83.8% (31/37) of treatment‐naive subjects and 12.0% (9/75) ( P < .001) receiving rescue treatment were susceptible to at least one of the three tested antibiotics. Overall, susceptibility‐guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%‐97.7%) by intent‐to‐treat analysis and 99% (100/101, 95% CI 97.1%‐100%) by per‐protocol analysis. All regimens achieved eradication rates greater than 90% ( P = .327) in the PP populations. Adverse events were relatively frequent; however, compliance remained high. Conclusion Susceptibility‐guided therapy proved highly effective for penicillin‐allergic patients. When available and proven locally effective, the alternative was empiric classical bismuth quadruple therapy. This trial is registered with ClinicalTrials.gov as NCT03708848.