Levofloxacin Concomitant Versus Levofloxacin Sequential

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDamascus Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • sequential

    Drug

    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

  • Levofloxacin 500Mg Oral Tablet

    Drug

    Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: sequentialExperimental treatment 1 intervention
Group B: concomitantActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Eradication rate of Helicobacter pylori infection

Eradication rate of Helicobacter infected patients

Time frame
8 week from begning of treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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