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

Helicobacter Pylori Gastrointestinal Tract Infection Clinical Trial

Official title:

Comparison Efficacy of 14-day Triple Therapy Between Clarithromycin and Levofloxacin on the Eradication of Helicobacter Pylori in Syrian Population

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02693574
• Other study ID #: G1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 11, 2016
• Last updated: March 18, 2017
• Start date: December 1, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: January 2017
• Source: Damascus Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: May 31, 2017
• Est. primary completion date: January 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Pylori Gastrointestinal Tract Infection

Intervention

Drug:
• Clarithromycin

• Levofloxacin

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus Hospital	Damascus

Sponsors (3)

Lead Sponsor	Collaborator
Damascus Hospital	Ibn Alhaytham Pharma. Industries Co, UNIPHARMA. Universal Pharmaceutical Industries

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

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