Health Condition 1: B998- Other infectious disease
Conditions
Interventions
Intervention1: Vonoprazan
Amoxicillin
Metronidazole.: 20 mg, BD, orally, 14 days
500 mg, TID, orally, 14 days
400 mg, BD, orally, from day 8-14.
Control Intervention1: Vonoprazan
Amoxicillin.: 20 mg, BD, orally, 14 days
500 mg, TID, orally, 14 days.
Sponsors
Dr Kishor H
Eligibility
Inclusion criteria
Inclusion criteria: Age above 18 years. 1.Treatment-na ve H. pylori infection confirmed by: Endoscopy or Stool antigen test positive. 2.Willing and able to attend day 14 and Week 6 visit.
Exclusion criteria
Exclusion criteria: 1.Patient received prior H. pylori eradication therapy. 2.Patient with known allergies to Penicillins, Metronidazole, or Vonoprazan. 3.Pregnant and Lactating women. 4.Any Active upper GI bleeding, perforated Ulcer, or histologically confirmed gastric malignancy (Past records). 5.Patients on Immunosuppressive therapy. 6.Patients of any prior gastric surgery. 7.Patients with known or suspected gastric malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of H. pylori eradication at week 6 post treatment, by a stool antigen test.Timepoint: week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the incidence and severity of adverse events (AEs) during treatment, graded by CTCAE v5.0.Timepoint: day 7, day 14, week 6;Determination of change in GI symptom from baseline using the Gastrointestinal symptom rating scale (GSRS) at Day 14 and week 6.Timepoint: day 7, day 14, week 6;Determination patient adherence measured by using pill count method.Timepoint: day 7, day 14, week 6;Assessing Health-related quality of life (EQ-5D-5L) at baseline and Week 6.Timepoint: day 7, day 14, week 6;Cost-per-eradication analysis including drug costs and adverse event management costs.Timepoint: day 7, day 14, week 6 | — |
Countries
India
Contacts
Public ContactDr Manjari Sharma
PESU Institute Of Pharmacy
Outcome results
None listed