Comparison of Helicobacter pylori Eradication Rates Between 5-Day and 10-Day Levofloxacin-Based Triple Therapy Regimens
Design
A phase 3, randomized, controlled, parallel-group clinical trial conducted on 120 patients with Helicobacter pylori infection confirmed by biopsy. The Excel RAND function was used for randomization.
Settings and conduct
Study Setting: Ayatollah Rohani Hospital, Babol
Methodology: Patients with confirmed H. pylori infection (via gastric biopsy) were randomly assigned to treatment groups.
Participants/Inclusion and exclusion criteria
The inclusion criteria for this study consist of all individuals between 18 and 60 years of age with a histologically confirmed Helicobacter pylori infection who voluntarily consent to participate.
The exclusion criteria : a history of prior H. pylori eradication therapy; severe or chronic diseases; pregnant women; recent use (within the past month) of NSAIDs, antibiotics, or proton pump inhibitors; previous gastric surgery; severe renal impairment (creatinine >2 mg/dL); significant hepatic dysfunction; gastric cancer; and hypersensitivity to any of the study medications (levofloxacin, amoxicillin, or pantoprazole).
Intervention groups
The 5-day treatment group received amoxicillin 1 g twice daily, levofloxacin 500 mg (Tavanex®, Abidi Pharma) once daily and pantoprazole 40 mg (Abidi Pharma) twice daily for 5 days
The 10-day treatment group received amoxicillin 1 g twice daily, levofloxacin 500 mg (Tavanex®, Abidi Pharma) once daily and pantoprazole 40 mg (Abidi Pharma) twice daily for 10 days
Main outcome variables
H. pylori eradication rate, treatment-related adverse events, patient compliance rates.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250426065481N1
Registration date:2025-05-27, 1404/03/06
Registration timing:registered_while_recruiting
Last update:2025-05-27, 1404/03/06
Update count:0
Registration date
2025-05-27, 1404/03/06
Registrant information
Name
Amin Vahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4324 0633
Email address
dr.aminvahedi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-20, 1404/02/30
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of 5-day and 10-day levofloxacin based triple regimen to eradication of helicobacter pylori: An open-label randomized clinical trial
Public title
Comparison of 5-day and 10-day levofloxacin based triple regimen to eradication of helicobacter pylori: An open-label randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All individuals aged 18 to 60 with a histologically confirmed Helicobacter pylori infection
The patient's consent to participate in the study
Exclusion criteria:
Prior treatment for H. pylori eradication
Severe and chronic medical conditions
Pregnant women
History of NSAID, antibiotic, or PPI use within the last 30 days
Prior stomach surgery
Severe kidney dysfunction [serum creatinine >2 mg/dL]
Severe liver dysfunction
Known hypersensitivity to levofloxacin, amoxicillin, or pantoprazole
Gastric cancer
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Type: Simple randomization- Individual-level randomization
Randomization Tool: Participants are randomly assigned to groups using a computer-generated randomization code. Allocation is performed automatically without stratification or blocking. patients are assigned to either 5-day or 10-day treatment groups based on the pre-generated randomization code.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of health research institute- Babol university of medical sciences