Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori

Phase 4

• Conditions: Helicobacter Pylori Gastrointestinal Tract Infection
• Interventions: Drug: Clarithromycin; Drug: Levofloxacin

• Registration Number: NCT02693574
• Lead Sponsor: Damascus Hospital

Brief Summary

Comparison Efficacy of 14-day Triple Therapy between Clarithromycin and levofloxacin on the Eradication of Helicobacter Pylori in Syrian population

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-23
• Study First Posted: 2016-02-26
• Status Verified: 2017-01
• Primary Completion: 2017-01-28
• Last Update Submitted: 2017-03-18
• Last Update Posted: 2017-03-21
• Study Completion: 2017-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clarithromycin	Clarithromycin	Clarithromycin 500 mg Tablets and Esomeprazole 20 mg Capsule And Amoxicillin 1000 mg,Tablets by mouth every 12 hours for 14 days
Levofloxacin	Levofloxacin	Levofloxacin 500 mg coated tablets and Esomeprazole 20 mg Capsule and Amoxicillin 1000 mg Tablets by mouth every 12 hours for 14 days

Primary Outcome Measures

Name	Time	Method
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis	6 weeks after eradication therapy

Trial Locations

Locations (1)

Damascus Hospital; 🇸🇾 Damascus, Syrian Arab Republic