Fourteen-day amoxicillin- or tetracycline-containing bismuth quadruple therapy versus 14-day metronidazole based triple therapy as a first-line treatment for clarithromycin resistant Helicobacter pylori infection : A multicenter randomized controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Dong-A University Hospital
- Enrollment
- 198
Study Overview
Brief Summary
A total of 198 patients with clarithromycin-resistant Helicobacter pylori infection were randomly assigned in a 1:1:1 ratio to the PAM (n=66), PAM-B (n=66), and PBMT (n=66) groups. The overall eradication rate was 88.8%. In the intention-to-treat (ITT) analysis, eradication rates were 68.2% in the PAM group, 84.7% in the PAM-B group, and 81.8% in the PBMT group. The PAM-B group showed a significantly higher eradication rate than the PAM group (p=0.024), with no significant difference between the PAM-B and PBMT groups (p=0.640). In the per-protocol (PP) analysis, eradication rates were 75.4% (PAM), 96.5% (PAM-B, p=0.001 vs. PAM), and 94.6% (PBMT, p=0.004 vs. PAM), with no significant difference between PAM-B and PBMT (p=0.633). Regarding adverse events, nausea and vomiting were significantly less frequent in the PAM-B group (6.8%) than in the PBMT group (25.0%, p=0.007). Severe adverse events were rare, and all symptoms resolved after discontinuation of therapy.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18(Year) to 80(Year) (—)
- Sex
- All
Inclusion Criteria
- •? Adults aged 18 to 80 years of both sexes. ? Patients diagnosed with Helicobacter pylori infection via endoscopy, confirmed by at least one of the following methods: histology, rapid urease test, serology, or urea breath test. ? Patients with clarithromycin resistance confirmed by dual-priming oligonucleotide polymerase chain reaction (DPO-PCR). ? Patients who provided written informed consent after receiving a full explanation of the study objectives and procedures.
Exclusion Criteria
- •? Patients with a history of prior Helicobacter pylori eradication therapy. ? Patients with a history of gastric surgery (e.g., gastrectomy). ? Patients with severe hepatic or renal impairment. ? Patients with a history of antibiotic allergy. ? Patients who had taken antibiotics within 4 weeks prior to study enrollment. ? Pregnant or lactating women.
Arms & Interventions
Drug : This study was a prospective, randomized controlled trial comparing three oral eradication regimens in patients with clarithromycin-resistant Helicobacter pylori (H. pylori) infection. All medications were administered orally, and the treatment duration was 14 days for all three arms.
Intervention: Drug : This study was a prospective, randomized controlled trial comparing three oral eradication regimens in patients with clarithromycin-resistant Helicobacter pylori (H. pylori) infection. All medications were administered orally, and the treatment duration was 14 days for all three arms.