Phase 4
N=330
Comparison Between Quadruple Regimens for Helicobacter Pylori Infection in Egypt
Helicobacter Pylori Infection
Bottom Line
View on ClinicalTrials.gov: NCT04039412 ↗Enrolled (actual)
330
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Percentage of Helicobacter Pylori Infection Cure — 102; 101; 91 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hybrid regimen (Drug); Reverse hybrid regimen (Drug); Levofloxacin quadruple regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ayman Magd Eldin Mohammad Sadek
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Helicobacter Pylori Infection Cure |
102; 101; 91 | — |
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
49; 58; 44 | — |
| SECONDARY Rate of Helicobacter Pylori Treatment Completion |
109; 107; 108 | — |
Summary
The overall prevalence of H. Pylori in the developing countries is 50.8%, with the highest one presented in Africa (79.1%). Hybrid therapy is supposed to be more effective as a first-line regimen for Helicobacter pylori infection in Egypt than the Reverse hybrid and non-bismuth Levofloxacin quadruple therapies. We are aiming here to compare the Hybrid, Reverse hybrid, and Levofloxacin quadruple therapies as first-line therapy, trying to reach the safest, cost-effective, and compliance-inducing regimen in Egypt. We will conduct a randomized controlled (interventional) study at Zagazig University Hospital, internal medicine department clinic, on 330 patients. 110 patients will be allocated to each regimen.
Eligibility Criteria
Inclusion Criteria
- Positive Helicobacter pylori antigen in the stool
- Treatment-naive
Exclusion Criteria
- Previous treatment for Helicobacter pylori
- Drug hypersensitivity
Data sourced from ClinicalTrials.gov (NCT04039412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.