Clinical trial NCT06959368: Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
Official title: A Randomised Controlled Trial Comparing Vonoprazan Triple Therapy (Vonoprazan, Amoxicillin, Clarithromycin), and Standard Triple Therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter Pylori Eradication in Indian Population. VECTOR Trial - Vonoprazan Evaluation Compared to Standard Triple Therapy in Helicobacter Pylori eRadication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori (H Pylori) infection is associated with functional dyspepsia, peptic ulcer disease, atrophy and gastric cancer. The bacterium has been classified as grade I carcinogen by the WHO in 1994(1). Based on the clinical and microbiological data it is now well known to be the strongest risk factor for developing intestinal type and diffuse type of adenocarcinoma(2-4). While testing and treating asymptomatic persons is a grey area, it is now recommended to rule out H. pylori in un-investigated dyspepsia patients (5-7), and if detected, it must be treated. However, worldwide and especially in the Asian countries, we face a widespread problem of antibiotic resistance(8,9). Regimens are typically selected based on the varying regional clarithromycin resistance(6,9). There is a need for an efficient and reliable empirical therapy that can be universal, has maximal eradication rates irrespective of resistance patterns, has good compliance and minimal adverse events without the emergence of superbugs. We also need a reliable rescue therapy for H. pylori eradication failure.


Eligibility criteria: Inclusion Criteria:

* Adult (18 years - 80 years)
* Patient visiting clinic with dyspepsia, GERD, or non-bleeding peptic ulcer
* 13C-urea breath test (UBT) positive/ Rapid urease test positive (RUT) on endoscopic biopsy
* Off PPIs for 2 weeks

Exclusion Criteria:

* Penicillin allergy
* Recent use of antibiotics in the past 1 month
* Previous H. pylori therapy
* Intestinal metaplasia, gastric cancer, bleeding peptic ulcer
* Patient who is unable to understand study protocol or not consenting
* Pregnancy, lactation
* Patient on anticoagulation, NSAIDs
* Patient using drugs with interactions with vonoprazan, amoxicillin, clarithromycin or PPIs
* Cirrhosis, Chronic kidney disease, chronic lung disease

Primary outcomes:
measure: A randomised controlled trial comparing Vonoprazan triple therapy (Vonoprazan, Amoxicillin, Clarithromycin), and standard triple therapy (Esomeprazole, Amoxicillin, Clarithromycin) for Helicobacter pylori eradication in Indian population. VECTOR trial
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of adverse events and eradication rates in antibiotic-resistant strains.
timeFrame: 1 year
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: AIG hospitals
state: Telangana
Study officials:
References: