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

Helicobacter Pylori Gastrointestinal Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03021590
• Other study ID #: G5-17
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: December 2018
• Source: Damascus Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Gastrointestinal Tract Infection

Intervention

Drug:
• Clarithromycin 500Mg Oral Tablet
Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all ,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth
• Levofloxacin 500Mg Oral Tablet
Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus Hospital	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus Hospital

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori Eradication rate	Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis	6 weeks after eradication therapy