Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

Damascus Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Helicobacter Pylori Gastrointestinal Tract Infection

Treatments: Drug: Levofloxacin 500Mg Oral Tablet; Drug: Clarithromycin 500Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03021590

G5-17

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Clarithromycin :Concomitant Therapy

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin 500Mg Oral Tablet

Levofloxacin :Concomitant Therapy

Active Comparator group

Description:

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

Treatment:

Drug: Levofloxacin 500Mg Oral Tablet