Comparison Efficacy of 14-day Triple Therapy: Clarithromycin vs. Levofloxacin on Eradication of H. Pylori

D

Damascus Hospital

Status and phase

Unknown
Phase 4

Conditions

Helicobacter Pylori Gastrointestinal Tract Infection

Treatments

Drug: Clarithromycin
Drug: Levofloxacin

Study type

Interventional

Funder types

Other

Identifiers

NCT02693574
G1

Details and patient eligibility

About

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

Enrollment

74 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1-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

  1. Children and teenagers aged less than 18 years.
  2. Previous eradication treatment for H. pylori.
  3. Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
  4. History of gastrectomy.
  5. Gastric malignancy, including adenocarcinoma and lymphoma,
  6. Previous allergic reaction to antibiotics (Amoxicillin, Clarithromycin, Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
  7. Contraindication to treatment drugs.
  8. Pregnant or lactating women.
  9. Severe concurrent disease.
  10. Liver cirrhosis.
  11. Chronic kidney disease.
  12. Patients who cannot give informed consent by himself or herself.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

74 participants in 2 patient groups

Clarithromycin
Active Comparator group
Description:
Clarithromycin 500 mg Tablets and Esomeprazole 20 mg Capsule And Amoxicillin 1000 mg,Tablets by mouth every 12 hours for 14 days
Treatment:
Drug: Clarithromycin
Levofloxacin
Experimental group
Description:
Levofloxacin 500 mg coated tablets and Esomeprazole 20 mg Capsule and Amoxicillin 1000 mg Tablets by mouth every 12 hours for 14 days
Treatment:
Drug: Levofloxacin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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