Evidence map›Paper›PMID 38225650›Full record

ArticleTrials2024

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.

Marouf Alhalabi, Rasha Almokdad

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06065267 (Efficacy of Two-week Therapy With Levofloxacin-based Concomitant Regimen Versus Levofloxacin-based Sequential Regimen for Helicobacter Pylori Infection in Syrian Population), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 99% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06065267 phase4not yet recruitingnot on this map

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

TypeinterventionalSponsorDamascus HospitalRan2024 to 2027Enrolled150ConditionsHelicobacter Pylori InfectionArmssequential, Levofloxacin 500Mg Oral Tablet
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Marouf AlhalabiGastroenterology Department, Damascus Hospital, Almujtahed Street, Damascus, Syria. e.marouf@hotmail.com.ORCID http://orcid.org/0000-0001-5027-2096
Rasha AlmokdadGastroenterology Department, Damascus Hospital, Almujtahed Street, Damascus, Syria.ORCID http://orcid.org/0000-0003-1637-7796
Damascus Hospital · SY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreating Helicobacter pylori is becoming increasingly difficult with the development of bacterial resistance to many established treatment regimens. As a result, researchers are constantly looking for novel and effective treatments. This trial aims to establish the efficacy of levofloxacin-based sequential treatment regimen and concomitant levofloxacin-based regimen as empirical first-line therapy in the Syrian population.

methodThis is an open-label, prospective, single-center, parallel, active-controlled, superiority, randomized clinical trial. The recruitment will target Helicobacter pylori-positive males and females between the ages of 18 and 65 to evaluate the efficacy of empirical first-line therapy in the Syrian population. We are planning to recruit up to 300 patients which is twice the required sample size. One hundred fifty individuals will be randomly assigned to undergo either a sequential levofloxacin-based treatment regimen or a concomitant levofloxacin-based regimen. High-dose dual therapy (proton-pump inhibitor and amoxicillin) will be the rescue therapy in the event of first-line failure. The first-line eradication rate in both groups is the primary outcome, and one of the secondary outcomes is the overall eradication rate of high-dose dual therapy in the event of first-line treatment protocol failure. Intention-to-treat analysis and per-protocol analysis will be used to evaluate the eradication rates of Helicobacter pylori for first-line treatment protocols. DISCUSSION: For the first time in the Syrian population, this randomized controlled trial will provide objective and accurate evidence about the efficacy of a sequential levofloxacin-based treatment regimen.

trial registrationClinicalTrials.gov NCT06065267 . Registered on October 3, 2023. Prospective registered. Enrollment of the first participant has not started yet.

Indexed as

Helicobacter InfectionsHelicobacter pyloriAdolescentAdultAgedAnti-Bacterial AgentsDrug Therapy, CombinationEquivalence Trials as TopicFemaleHumansLevofloxacinMaleMetronidazoleMiddle AgedProspective StudiesProton Pump InhibitorsAnti-Bacterial AgentsLevofloxacinMetronidazoleProton Pump InhibitorsAmoxicillinConcomitantEsomeprazoleHelicobacter PyloriLevofloxacinMetronidazoleProton bump inhibitorSequentialSyriaTinidazole

Identifiers

PMID38225650
PMCPMC10789050
OpenAlexW4390880913

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.