Digestive System Helicobacter pylori
Conditions
Interventions
Clarithromycin based triple therapy
Concomitant Non Bismuth Quadruple Therapy
Levofloxacin triple therapy
Sponsors
University of Global Health Equity
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria to be eligible for enrollment: • Adults aged =18 years • Confirmed Helicobacter pylori infection by stool antigen test • Presence of dyspeptic symptoms or related upper gastrointestinal symptoms warranting eradication therapy • Treatment naïve, or prior H. pylori treatment completed > 2 months before screening • Able and willing to provide written informed consent • Willing and able to comply with study procedures and follow-up visits
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded: • Previous treatment for H. pylori infection < 2 months • Known hypersensitivity or contraindication to any study medication • Current pregnancy or breastfeeding • Severe hepatic or renal impairment that may affect drug metabolism or safety • Concomitant medications with known contraindicated drug–drug interactions that preclude safe participation • Inability to swallow oral medicines or inability to complete essential study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H. pylori eradication success, defined as a negative stool antigen test (SAT) result at the test of cure visit (Week 4–6 post-treatment), performed at least four weeks after the last dose of antibiotics and at least two weeks after the last dose of proton pump inhibitor to avoid false-negative results. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability: The proportion of participants experiencing at least one adverse event, at least one treatment-related adverse event, and at least one serious adverse event during the treatment period and follow-up, classified using MedDRA terminology and graded by severity according to CTCAE version 5.0, compared across the four treatment arms.;Treatment adherence and completion: The proportion of participants classified as adherent, defined as taking 80% or more of prescribed doses over the 14-day treatment course as assessed by pill count, and the proportion completing the full treatment course without premature discontinuation, compared across the four treatment arms;Dyspeptic symptom improvement: The mean change in Glasgow Dyspepsia Severity Score (GDSS) from baseline (Day 0) to the test of cure visit (Week 4–6), compared across the four treatment arms. A minimum clinically important difference (MCID) of three or more points reduction in the GDSS score is pre-specified.;Health-related quality of life: The mean change in Nepean Dyspepsia Index short form (NDI-SF) total score from baseline (Day 0) to the test of cure visit (Week 4–6), compared across the four treatment arms.;Cost-effectiveness: The incremental cost per additional successful H. pylori eradication for each treatment arm relative to the least costly regimen, estimated from a healthcare system perspective considering direct medical costs only, including medication costs, adverse event management costs, and costs of additional healthcare contacts attributable to treatment failure. | — |
Countries
Rwanda
Contacts
Public ContactZainab Ingabire
Gastroenterologist King Faisal Hospital
Outcome results
None listed