Eradication of H. Pylori Infection With Moxifloxacin (RCT)

Iyad Naeem Muhammad, PhD

Status and phase: Completed; Phase 3

Conditions: Helicobacter Pylori Infection, Susceptibility to; Helicobacter Pylori Infection

Treatments: Drug: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID; Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID

Study type: Interventional

Funder types: Other

Identifiers

NCT05863858

RCT-HP-01

Details and patient eligibility

About

The main objective of the study is to compare the effectiveness of moxifloxacin triple therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and patient compliance.

Full description

Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly assigned to the eradication treatments. At four weeks after completion of eradication therapy, H. pylori tests were performed with a Stool antigen test.

Enrollment: 162 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Successful isolation of H. pylori from the patient, and
2. patients of at least 18 years of age.

Exclusion criteria

1. age under 18 years
2. presence of clinically significant associated conditions (insulin-dependent diabetes mellitus, gastrointestinal bleeding, neoplastic diseases, coagulation disorders, and neurologic, metabolic, hematological or endocrine hepatic, cardiorespiratory, or renal diseases),
3. previous gastric surgery,
4. allergy to any of the drugs used in the study, and (5) pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Levofloxacin-based sequential Therapy

Active Comparator group

Description:

1. Tablets Levofloxacin 500mg BID for the first five days 2. Tablet Amoxicillin 1 gm BID for first five days 3. Capsules Omeprazole 20 mg BID for first five days followed by 1. Tablet Levofloxacin 500 mg BID for five days 2. Tablet Tinidazole 500mg BID for five days 3. Capsule Omeprazole 20 mg BID for five days Infection eradication will be observed and confirmed by stool antigen test correlated with the signs and symptoms

Treatment:

Drug: Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID

Moxifloxacin-based Triple Therapy

Active Comparator group

Description:

1. Tablet Moxifloxacin 400 mg OD for ten days 2. Tablet Amoxicillin 1 gm BID for ten days 3. Capsule Omeprazole 20 mg BID for ten days Infection eradication will be observed and confirmed with a stool antigen test along with patient compliance and tolerability observance.

Treatment:

Drug: Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID