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

Damascus Hospital

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Gastrointestinal Tract Infection

Treatments: Drug: Clarithromycin; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02693574

G1

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Clarithromycin

Active Comparator group

Description:

Clarithromycin 500 mg Tablets and Esomeprazole 20 mg Capsule And Amoxicillin 1000 mg,Tablets by mouth every 12 hours for 14 days

Treatment:

Drug: Clarithromycin

Levofloxacin

Experimental group

Description:

Levofloxacin 500 mg coated tablets and Esomeprazole 20 mg Capsule and Amoxicillin 1000 mg Tablets by mouth every 12 hours for 14 days

Treatment:

Drug: Levofloxacin