LOAD VS Levofloxacine Concomitant

Damascus Hospital

Status and phase: Enrolling; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Levofloxacin 500mg; Drug: Doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT04626193

G-10-20

Details and patient eligibility

About

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

Enrollment: 80 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: Single Blind

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80 participants in 2 patient groups

Doxycyclien

Experimental group

Description:

Measure eradication rate of Helicobacter pylori infection with Doxycycline,Levofloxacien,tinadizole

Treatment:

Drug: Doxycycline

Levofloxacine

Active Comparator group

Description:

Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole,amoxicilline

Treatment:

Drug: Levofloxacin 500mg