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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03021590
• Date of registration: 05/01/2017
• Prospective Registration: Yes
• Primary sponsor: Damascus Hospital
• Public title: Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
• Scientific title: Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
• Date of first enrolment: June 1, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03021590
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Syrian Arab Republic

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Helicobacter Pylori Gastrointestinal Tract Infection

Intervention(s)

Drug: Clarithromycin 500Mg Oral Tablet

Drug: Levofloxacin 500Mg Oral Tablet

Primary Outcome(s)

Helicobacter pylori Eradication rate [Time Frame: 6 weeks after eradication therapy]

Secondary ID(s)

G5-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors