Clinical trial NCT05863858: Eradication of H. Pylori Infection With Moxifloxacin
Official title: High Eradication Rate of Helicobacter Pylori Infection With Moxifloxacin-Based Triple Therapy in Comparison With Levofloxacin-Based Sequential Therapy: Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Helicobacter Pylori Infection, Susceptibility to
Keywords: Triple therapy with moxifloxacin
Helicobacter pylori
Levofloxacin sequential therapy
Stool Antigen test
Lead sponsor: University of Karachi
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized into two regimens:

1. Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or
2. Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Helicobacter pylori status one month after treatment.
timeFrame: One month after finishing with therapy.
Secondary outcomes:
measure: Compliance of patients in both therapy groups in treatment of Helicobacter pylori infection.
timeFrame: One month after finishing with therapy.
measure: Adverse effects of therapy in both groups in treatment of Helicobacter pylori infection.
timeFrame: One month after finishing with therapy.
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Jamal Noor Hospital, Karachi
state: Sindh
Study officials:
affiliation: Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi
name: Iyad N Muhammad, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rakici H, Ayaz T, Akdogan RA, Bedir R. Comparison of levofloxacin- and moxifloxacin-based triple therapies with standard treatment in eradication of Helicobacter pylori as first-line therapy. Digestion. 2014;90(4):261-4. doi: 10.1159/000369788. Epub 2014 Dec 24.
citation: Mori H, Suzuki H. Update on quinolone-containing rescue therapies for Helicobacter pylori infection. World J Gastroenterol. 2020 Apr 21;26(15):1733-1744. doi: 10.3748/wjg.v26.i15.1733.
citation: Hsu PI, Tsay FW, Kao JY, Peng NJ, Chen YH, Tang SY, Kuo CH, Kao SS, Wang HM, Wu IT, Shie CB, Chuah SK, Wu DC; Taiwan Acid-related Disease, Microbiota (TARD-M) Consortium. Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection. Helicobacter. 2021 Oct;26(5):e12840. doi: 10.1111/hel.12840. Epub 2021 Aug 12.
citation: Hwang JJ, Lee DH, Yoon H, Shin CM, Park YS, Kim N. Efficacy of moxifloxacin-based sequential and hybrid therapy for first-line Helicobacter pylori eradication. World J Gastroenterol. 2015 Sep 21;21(35):10234-41. doi: 10.3748/wjg.v21.i35.10234.