Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
Phase 4
Withdrawn
- Conditions
- Helicobacter Pylori Gastrointestinal Tract Infection
- Interventions
- Registration Number
- NCT03021590
- Lead Sponsor
- Damascus Hospital
- Brief Summary
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-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
- Children and teenagers aged less than 18 years.
- Previous eradication treatment for H. pylori.
- Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
- History of gastrectomy.
- Gastric malignancy, including adenocarcinoma and lymphoma,
- Previous allergic reaction to antibiotics (Amoxicillin, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
- Contraindication to treatment drugs.
- Pregnant or lactating women.
- Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.
- Patients who cannot give informed consent by himself or herself.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levofloxacin :Concomitant Therapy Levofloxacin 500Mg Oral Tablet Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth Clarithromycin :Concomitant Therapy Clarithromycin 500Mg Oral Tablet Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth
- Primary Outcome Measures
Name Time Method Helicobacter pylori Eradication rate 6 weeks after eradication therapy Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Damascus Hospital
🇸🇾Damascus, Syrian Arab Republic