Helicobacter Pylori Gastrointestinal Tract Infection
Conditions
Keywords
Helicobacter pylori, Helicobacter Infections, Proton Pump Inhibitors
Brief summary
Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the Eradication of Helicobacter Pylori in Syrian population
Interventions
DRUGClarithromycin
DRUGLevofloxacin
Sponsors
UNIPHARMA. Universal Pharmaceutical Industries
Ibn Alhaytham Pharma. Industries Co
Damascus Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1-Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.
Exclusion criteria
1. Children and teenagers aged less than 18 years. 2. Previous eradication treatment for H. pylori. 3. Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics. 4. History of gastrectomy. 5. Gastric malignancy, including adenocarcinoma and lymphoma, 6. Previous allergic reaction to antibiotics (Amoxicillin, Clarithromycin, Levofloxacin) and prompt pump inhibitors (Es-omeprazole). 7. Contraindication to treatment drugs. 8. Pregnant or lactating women. 9. Severe concurrent disease. 10. Liver cirrhosis. 11. Chronic kidney disease. 12. Patients who cannot give informed consent by himself or herself.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis | 6 weeks after eradication therapy |
Countries
Syria
Outcome results
None listed