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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03021590

Enrollment

Registered

2017-01-16

Start date

2017-06-01

Completion date

2022-01-31

Last updated

2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Gastrointestinal Tract Infection

Keywords

Helicobacter pylori, Helicobacter Infections, Proton Pump Inhibitors, sequential therapy, Clarithromycin, Tinidazole

Brief summary

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

Interventions

DRUGClarithromycin 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

DRUGLevofloxacin 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026