Levofloxacin Concomitant Versus Levofloxacin Sequential
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: sequential, Levofloxacin 500Mg Oral Tablet.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Syria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population: a Prospective Single-center Randomized Controlled Trial
Overview
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
Interventions
- Drug sequential
amoxicillin 1000 mg bid ,esomprazole 20 bid for one week then levofloxacine 500 mg q.d, metraonidazoel 500 500 bid, and esomprazole 20 bid for one week - Drug Levofloxacin 500Mg Oral Tablet
Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
Primary outcome measures
- Eradication rate of Helicobacter pylori infection [Time frame: 8 week from begning of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Syria · 1 center
- General Assembly of Damascus Hospital — Damascus
Publications
- Alhalabi M, Almokdad R. Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial. Trials. 2024 Jan 15;25(1):55. doi: 10.1186/s13063-024-07906-3. PMID 38225650
Identifiers
NCT: NCT06065267 · G-9-23