METHODS: We undertook a multicenter, double-blind, superiority, randomized controlled trial involving 7 Australian, New Zealand, and Malaysian hospitals. Children aged 3 months to ≤5 years hospitalized with radiographic-confirmed CAP who received 1-3 days of intravenous antibiotics, then 3 days of oral amoxicillin-clavulanate, were randomized to either extended-course (8-day oral amoxicillin-clavulanate) or standard-course (8-day oral placebo) arms. Children were reviewed at 12 and 24 months. The primary outcome was children with the composite endpoint of chronic respiratory symptoms/signs (chronic cough at 12 and 24 months; ≥1 subsequent hospitalized acute lower respiratory infection by 24 months; or persistent and/or new chest radiographic signs at 12-months) at 24-months postdischarge, analyzed by intention-to-treat, where children with incomplete follow-up were assumed to have chronic respiratory symptoms/signs ("worst-case" scenario).
RESULTS: A total of 324 children were randomized [extended-course (n = 163), standard-course (n = 161)]. For our primary outcome, chronic respiratory symptoms/signs occurred in 97/163 (60%) and 94/161 (58%) children in the extended-courses and standard-courses, respectively [relative risk (RR) = 1.02, 95% confidence interval (CI): 0.85-1.22]. Among children where all sub-composite outcomes were known, chronic respiratory symptoms/signs between groups, RR = 1.10, 95% CI: 0.69-1.76 [extended-course = 27/93 (29%) and standard-course = 24/91 (26%)]. Additional sensitivity analyses also revealed no between-group differences.
CONCLUSION: Among children from high-risk populations hospitalized with CAP, 13-14 days of antibiotics (versus 5-6 days), did not improve long-term respiratory outcomes.
OBJECTIVE: To describe the time trends of use, effectiveness and safety of BQT in Europe using the European Registry on Helicobacter pylori Management (Hp-EuReg).
DESIGN: Patients registered in the Hp-EuReg from 2013 to 2021 who had received BQT were included. The regimens prescribed, the number of eradication attempts, effectiveness, adherence and safety were analysed. The effectiveness was assessed by modified intention to treat (mITT). Time-trend and multivariate analyses were performed to determine variables that predicted treatment success.
RESULTS: Of the 49 690 patients included in the Hp-EuReg, 15 582 (31%) had received BQT. BQT use increased from 8.6% of all treatments in 2013 to 39% in 2021. Single-capsule BQT-containing bismuth, metronidazole and tetracycline-plus a PPI (single-capsule BQT, ScBQT) was the most frequent treatment mode (43%). Schemes that obtained an effectiveness above 90% were the 10-day ScBQT and 14-day BQT using tetracycline plus metronidazole, or amoxicillin plus either clarithromycin or metronidazole. Only ScBQT achieved above 90% cure rates in all the geographical areas studied. Using the ScBQT scheme, adherence, the use of standard or high-dose PPIs, 14-day prescriptions and the use of BQT as first-line treatment were significantly associated with higher mITT effectiveness.
CONCLUSION: The use of BQT increased notably in Europe over the study period. A 10-day ScBQT was the scheme that most consistently achieved optimal effectiveness.
TRIAL REGISTRATION NUMBER: NCT02328131.
METHODS: The Upper Gastrointestinal (GI) Focus Group of the Asian Pacific Association of Gastroenterology-Emerging Leaders Committee developed an international survey, which was distributed to 98 clinicians in the Asia-Pacific region, compromising an online questionnaire focusing on the management of H. pylori infection.
RESULTS: Participants responded from Japan (15, 15.3%), Hong Kong (15, 15.3%), Thailand (33, 33.7%), Vietnam (23, 23.5%), Malaysia (4, 4.1%), Singapore (3, 3.1%), and others (5, 5.1%). The most common first-line eradication regimen was clarithromycin (CAM) triple therapy, including proton pump inhibitor (PPI), amoxicillin (AMPC), and CAM (64.3%) for 14 days (70.4%). The most common second-line eradication regimen was levofloxacin (LVX) triple therapy, including PPI, AMPC, and LVX (22.4%) for 14 days (67.3%). Eradication therapy was deemed necessary for all asymptomatic adults and minors (aged ≤ 17 years) currently infected with H. pylori by 81.6% and 64.3% of respondents, respectively, with 82.7% considering upper GI endoscopy for GC screening useful in the secondary prevention of GC.
CONCLUSION: There appears to be a growing consensus among clinicians, acknowledging the necessity of eradication therapy. We anticipate that this study will establish a new benchmark in preventive medicine aimed at eradicating GC in the Asia-Pacific region.
METHODS: This was an analysis of an international, prospective, non-interventional registry on the management of Helicobacter pylori infection by European gastroenterologists (European Registry on Helicobacter pylori Management [Hp-EuReg]). Patients receiving empirical bismuth-containing quadruple therapies in any treatment line and registered from 2013 to 2024 were included. Effectiveness was assessed using a modified intention-to-treat (mITT) analysis.
RESULTS: A total of 10,767 first-line records were analyzed. The clarithromycin-amoxicillin-bismuth (CAB) scheme was >90% effective with standard doses of amoxicillin and clarithromycin (2000 mg/d and 1000 mg/d), regardless of bismuth dose. The bismuth-metronidazole-tetracycline (BMTc) regimen achieved >90% effectiveness with tetracycline ≥1500 mg/d, metronidazole 1500 mg/d, and bismuth ≥480 mg/d. The amoxicillin-metronidazole-bismuth (AMB) regimen reported ≈90% mITT with amoxicillin 2000 mg/d, metronidazole ≥1000 mg/d, and bismuth 480 mg/d. The clarithromycin-metronidazole-bismuth (CMB) showed ≥90% mITT with metronidazole ≥800 mg/d, without improvement from increasing bismuth dose. In the amoxicillin-levofloxacin-bismuth (ALB) regimen, mITT was >90%, with no benefit from increasing levofloxacin >500 mg/d. A total of 2952 second- to sixth-line treatments were analyzed, all showing mITT <90% (ALB, 83%; BMTc, 79%; CAB, 88%; MDB, 63%; AMB, 88%), with no significant differences with different bismuth doses.
CONCLUSIONS: Increasing antibiotic or bismuth doses above the standard did not improve effectiveness of H pylori treatment. Adherence, treatment length, and proton pump inhibitor co-therapy may be more impactful than escalation of antibiotics/bismuth doses.
CLINICALTRIALS: gov, Number: NCT02328131.