Levofloxacin Concomitant Versus Levofloxacin Sequential

Damascus Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06065267

G-9-23

Details and patient eligibility

About

The goal of this trial is to determine the efficacy of levofloxacin based sequential treatment regimen or concomitant levofloxacin based regimens as empirical first-line therapy in the Syrian population

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 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:
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 2 patient groups

sequential

Experimental group

Description:

Measure eradication rate of Helicobacter pylori infection with Levofloxacien sequential based regimen

Treatment:

Drug: sequential

concomitant

Active Comparator group

Description:

Measure eradication rate of Helicobacter pylori infection with Livofloxacine concomitant based regimen

Treatment:

Drug: Levofloxacin 500Mg Oral Tablet