Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.

NCT02726269 | Completed Phase 3

• 1 other identifier: ASO HO 01
• Study Type: interventional
• Target: 230
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this trial is to compare the non-inferiority efficacy and safety of two different treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily (PLA, test) vs. clarithromycin 500 mg + lansoprazole 30 mg + amoxicillin 1 g twice daily (CLA, reference), each during 10 days, over Helicobacter Pylori (HP) eradication. Both schemes will be tested in treatment-naive patients, with biopsy-based diagnosis for HP infection. One month after finishing each treatment, C13-urea breath testing will be required to verify HP eradication. Biopsies will also be taken to identify Clarithromycin-resistance mutations in HP strains by fluorescence in situ hybridization (FISH).

Conditions

Helicobacter Pylori Gastritis

Keywords

Helicobacter Pylory infections; Levofloxacin; Antibiotic resistance; Clarithromycin; Mutations; Fluorescence; Hybridization

Outcome Measures

Primary Outcomes (1)

• HP eradication rate calculated from negative 13C-urea breath tests.

  Four weeks after the end of the allocated treatment.

Secondary Outcomes (2)

• Determine the frequency of Clarithromycin-resistance mutations by fluorescence in situ hybridization (FISH).

  Within a month after taking gastric endoscopy biopsy to confirm the diagnosis of HP infection.

• Compare the proportion of Clarithromycin-resistance mutations determined by FISH with the HP eradication rate calculated.

  A week after both proportions are calculated.

Other Outcomes (2)

• Percentage and type of Adverse Events (AEs) and Serious Adverse Events (SAEs) in each group (PLA vs CLA).

  Up to a month after the end of both treatments.

• Proportion of treatments prematurely suspended due to AEs or SAEs in each group (PLA vs CLA).

  Within ten days after each treatment is randomly allocated.

Study Arms (2)

CLA (Clarithro+Lanso+Amoxi)

ACTIVE COMPARATOR

Clarithromycin 500 mg bid, Lansoprazole 30 mg bid and Amoxicillin 500 bid, tablets of oral administration, during 10 days.

Drug: CLA (Clarithro+Lanso+Amoxi)

PLA (Panto+Levoflox+Azithro)

EXPERIMENTAL

Pantoprazole 80 mg od, Levofloxacin 500 mg od and Azithromycin 500 mg od, tablets of oral administration, during 10 days.

Drug: PLA (Panto+Levoflox+Azithro)

Interventions

CLA (Clarithro+Lanso+Amoxi) DRUG

Tablets of oral administration administered to subjects randomized to this group twice daily for 10 days.

Also known as: Pylopac®, Medix, Mexico

CLA (Clarithro+Lanso+Amoxi)

PLA (Panto+Levoflox+Azithro) DRUG

Tablets of oral administration to subjects randomized to this group once daily for 10 days.

Also known as: Zoltum®, Truxa® (MTV SA, Argentina), Levofloxacino, AsoMex

PLA (Panto+Levoflox+Azithro)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult subjects who wish to participate after signing the informed consent.
• Aged between 18 and 65 years.
• HP infection diagnosed by endoscopic gastric biopsy.
• Subjects who fulfill the following HP eradication criteria according to Maastricht 3 Consensus Report:
• Non ulcer dyspepsia with gastric biopsy positive for HP infection,
• Uncomplicated duodenal ulcer (without active bleeding, perforation or stenosis) with gastric biopsy positive for HP infection,
• Uncomplicated benign gastric ulcer (without active bleeding, perforation or stenosis) with gastric biopsy positive for HP infection,
• Chronic intake of NSAIDs with gastric biopsy positive for HP infection without active gastrointestinal bleeding.

You may not qualify if:

• Pregnant or lactating women.
• Subjects who have previously received the PLA or CLA treatment.
• Subjects who are diagnosed by endoscopy with upper gastrointestinal bleeding secondary to active peptic ulcer (gastric or duodenal) with injuries classified in any of the following stages of the Forrest Classification: I-a (Spurting hemorrhage), I-b (Oozing hemorrhage), II-a (Visible vessel) or II-b (Adherent clot).
• Subjects who are diagnosed by endoscopy with upper gastrointestinal bleeding by erosive gastritis secondary to active NSAID with positive biopsy for HP infection and whose clinical conditions require hospitalization and / or blood transfusion.
• Subjects with psychiatric disorders including eating disorders.
• Subjects with chronic degenerative diseases including uncontrolled hepatic, renal or endocrine diseases (except diabetes controlled by oral hypoglycemic agents or controlled hypothyroidism), malabsorption or chronic diarrhea, history of seizures or epilepsy, gastric surgery or subjects with oncological diseases.
• Subjects with previous allergic reactions to any of the treatment components: Pantoprazole, Amoxicillin, Clarithromycin, Azithromycin or Levofloxacin.
• Subjects with a history of photosensitivity or tendinitis secondary to quinolones intake.
• Subjects who are taking any of the following medications:
• NSAIDS: Fenbufen
• ergot
• Oral anticoagulants
• Cyclosporine
• Digoxin

Sponsors & Collaborators

• Asofarma de México S.A de C.V.: lead
• Hospital Ángeles, Clínica Londres, Mexico City: collaborator
• Centro InmunoQ, Mexico City: collaborator
• Torre Mayo, Metepec, State of Mexico: collaborator
• Hospital Ángeles Metropolitano, Mexico City: collaborator
• Centro Médico ABC Observatorio, Mexico City: collaborator

Related Publications (4)

• Cuadrado-Lavin A, Salcines-Caviedes JR, Carrascosa MF, Dierssen-Sotos T, Cobo M, Campos MR, Ayestaran B, Fernandez-Pousa A, Gonzalez-Colominas E, Aresti-Zarate S, Hernandez M, Pascual EL. Levofloxacin versus clarithromycin in a 10 day triple therapy regimen for first-line Helicobacter pylori eradication: a single-blind randomized clinical trial. J Antimicrob Chemother. 2012 Sep;67(9):2254-9. doi: 10.1093/jac/dks209. Epub 2012 Jun 11.

  PMID: 22687889 BACKGROUND

• Chihu L, Ayala G, Mohar A, Hernandez A, Herrera-Goepfert R, Fierros G, Gonzalez-Marquez H, Silva J. Antimicrobial resistance and characterization of Helicobacter pylori strains isolated from Mexican adults with clinical outcome. J Chemother. 2005 Jun;17(3):270-6. doi: 10.1179/joc.2005.17.3.270.

  PMID: 16038520 BACKGROUND

• Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.

  PMID: 23268518 BACKGROUND

• Ladron-de-Guevara L, Bornstein-Quevedo L, Gonzalez-Huezo S, Castaneda-Romero B, Costa FG, di Silvio-Lopez M. Helicobacter pylori eradication in Mexico with a levofloxacin-based scheme versus standard triple therapy: Results from an open-label, randomized, noninferiority phase iiib trial. Rev Gastroenterol Mex (Engl Ed). 2019 Jul-Sep;84(3):274-283. doi: 10.1016/j.rgmx.2018.04.005. Epub 2018 Jul 27. English, Spanish.

  PMID: 30060902 DERIVED

MeSH Terms

Interventions

Ofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alma L Ladrón de Guevara, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 1, 2016
• Study Start: June 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share