VA Dual Sequential Therapy
ConditionHelicobacter Pylori Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University
About this trial
Sequential therapy for Hp was first introduced by Zullo et al. in 2000 and consists of two phases: the first phase involves proton pump inhibitors with one antibiotic, and the second phase involves proton pump inhibitors with two antibiotics. Based on this, the investigators propose a modified sequential therapy, where the first phase uses vonoprazan combined with amoxicillin, and the second phase increases the amoxicillin dosage, forming a high-dose amoxicillin regimen. This new treatment strategy combines the staged nature of sequential therapy with the advantages of high-dose dual therapy, gradually increasing the drug dosage to help patients adapt and reduce side effects (such as nausea, vomiting, and diarrhea), thereby improving patient tolerance.
The primary aim of this study is to compare the vonoprazan combined with high-dose amoxicillin sequential therapy with standard dual therapy (14-day regimen) in terms of Hp eradication rates, efficacy, side effect incidence, and patient compliance, to evaluate its improved effectiveness. Additionally, the study will explore the impact of a shortened treatment duration on the modified dual sequential therapy's efficacy for Hp infection.
Eligible participants in this study will be randomly assigned to one of the following three treatment groups based on a pre-generated randomization sequence:
Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VADT-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.
Experimental Group 1: Vonoprazan combined with amoxicillin dual sequential therapy for 14 days (VAST-14):
Days 1 to 7: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 8 to 14: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.
Experimental Group 2: Vonoprazan combined with amoxicillin dual sequential therapy for 10 days (VAST-10):
Days 1 to 5: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 6 to 10: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-70 years, gender unrestricted.
Chronic gastritis patients with Helicobacter pylori positivity: (1) Helicobacter pylori positive is defined as a positive result on a carbon-13 or carbon-14 breath test within one month prior to enrollment; (2) Chronic gastritis is defined as a diagnosis based on gastroscopy within six months prior to enrollment.
No previous Helicobacter pylori eradication therapy.
Agree to participate in the trial and sign the informed consent form
Disqualifiers
Allergy to any of the drugs used in this clinical trial.
Previously received H. pylori eradication treatment.
Receiving Potassium-competitive acid blocker (P-CAB), proton pump inhibitor (PPI), H2 receptor antagonist, antibiotics, bismuth, probiotic preparations 4 weeks before initiating study treatment.
Use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period.
Trial design
Design model
Parallel
Treatments tested in this trial
Vonoprazan and Amoxicillin for the first 7 days
Drug20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 7 days
Vonoprazan and Amoxicillin for the first 5 days
Drug20mg Vonoprazan twice times daily and 1g Amoxicillin twice times daily for 5 days
Vonoprazan and Amoxicillin for the second 7 days
Drug20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 7 days
Vonoprazan and Amoxicillin for the second 5 days
Drug20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 5 days
Vonoprazan and Amoxicillin for 14 days
Drug20mg Vonoprazan twice times daily and 1g Amoxicillin three times daily for 14 days
Treatment groups
600 Participants
are divided into 3 treatment groupsGroup A: 14-day Vonoprazan-Amoxicillin dual sequential therapyExperimental treatment 2 interventions
Group B: 10-day Vonoprazan-Amoxicillin dual sequential therapyExperimental treatment 2 interventions
Group C: 14-day Vonoprazan-Amoxicillin dual therapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
H. pylori eradication rate
Rate of H. pylori successfully eradicated; The confirmation of H. pylori status was evaluated by Urea breath test.
Time frame
4-6 weeks after treatment completionSecondary outcomes
1
Patient compliance
Good compliance was defined as achieving ≥80% of drugs in the regimes and bad compliance was defined as achieving \<80% of drugs.
Time frame
1 day after treatment completion2
Adverse events
Adverse drug reactions, including the incidence of both overall and serious adverse events, will be assessed using a standardized questionnaire.
Time frame
For the 10-day intervention: assessment on Day 5 and Day 10; For the 14-day intervention: assessment on Day 7 and Day 14.3
Cost-effectiveness ratio
The cost-effectiveness ratio is defined as the total cost per patient for one course of H. pylori eradication treatment divided by the H. pylori eradication rate.
Time frame
1 day after the procedureSponsors and contacts
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Source ClinicalTrials.gov