LOAD VS Levofloxacine Concomitant

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparing the Efficacy of Two Weeks Therapy of Doxycycline,Levofloxacin,Tinidazole Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626193
• Other study ID #: G-10-20
• Status: Recruiting
• Phase: Phase 4
• Start date: October 31, 2020
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2020
• Source: Damascus Hospital
• Contact: Marouf MH Alhalabi, MD
• Phone: +963952781278
• Email: e.marouf[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:

• Positive rapid urease test (CLOtest).

• Histologic evidence of H. pylori by modified Giemsa staining.

• 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, Tinadizole,

• Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).

• Contraindication to treatment drugs.

• Pregnant or lactating women.

• Severe concurrent disease.

• Liver cirrhosis.

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Doxycycline
Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole 500 bid
• Levofloxacin 500mg
Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Locations

Country	Name	City	State
Syrian Arab Republic	General Assembly of 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	Eradication rate of Helicobacter pylori infection	Eradication rate of Helicobacter infected patients	8 week from begning of treatment