Concomitant Versus Hybrid Regimen for H. Pylori Eradication

NCT03592069 | Completed Phase 4

• 1 other identifier: AlexandraH
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief Summary

10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.

Conditions

H.Pylori Infection; H.Pylori Gastrointestinal Disease; H. Pylori Associated Phlegmonous Gastritis

Keywords

H. Pylori Infection; Gastritis; H.Pylori treatment; Treatment Resistance

Outcome Measures

Primary Outcomes (1)

• To compare eradication rates between a 10 day concomitant and a 14 day hybrid regimens in intention to treat and per protocol analyses

  2 YEARS

Secondary Outcomes (1)

• Adverse events during treatment

  2 YEARS

Study Arms (2)

10 day concomitant

ACTIVE COMPARATOR

After the confirmation of H. pylori infection, eligible patients randomly assigned to either concomitant or hybrid treatment group will receive: \- Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid.

Drug: 10 day concomitant regimen

14 day hybrid

ACTIVE COMPARATOR

After the confirmation of H. pylori infection, eligible patients randomly assigned to either concomitant or hybrid treatment group will receive: Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.

Drug: 14 day hybrid regimen

Interventions

10 day concomitant regimen DRUG

10 Day Concomitant Hp therapy Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid

Also known as: Amoxicillin 1gr bid from day 1 to day 10, Clarithromycin 500mg bid from day 1 to day 10, Metronidazole 500mg bid from day 1 to day 10, Esomeprazole 40mg bid from day 1 to day 10

10 day concomitant

14 day hybrid regimen DRUG

14 Day Hybrid Hp therapy Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.

Also known as: Amoxicillin 1gr bid from day 1 to day to day 14, Clarithromycin 500mg bid from day 8 to day 14, Metronidazole 500mg bid from day 8 to day 14, Esomeprazole 40mg bidfrom day 1 to day to day 14

14 day hybrid

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of 18 years or older referring for upper GI endoscopy
• infected with H. pylori (verified with 2 out of 3 tests - rapid urease test, histology, culture)
• without previous H. pylori eradication treatment (naïve)

You may not qualify if:

• age below 18 years
• presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, cardiovascular or pulmonary disease)
• previous gastric surgery
• gastric malignancies
• Zollinger-Elisson syndrome
• known allergy or other contraindications to the study medications
• previous H. pylori treatment
• use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month
• use of PPI in the preceding two weeks
• not willing to participate in the study
• pregnant or lactating women

Sponsors & Collaborators

• Alexandra Hospital, Athens, Greece: lead
• Hellenic Society of Gastroenterology: collaborator

Study Sites (1)

Alexandra General Hospital

Athens, 11528, Greece

Location

Related Publications (3)

• Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.

  PMID: 26187502 BACKGROUND

• Megraud F, Coenen S, Versporten A, Kist M, Lopez-Brea M, Hirschl AM, Andersen LP, Goossens H, Glupczynski Y; Study Group participants. Helicobacter pylori resistance to antibiotics in Europe and its relationship to antibiotic consumption. Gut. 2013 Jan;62(1):34-42. doi: 10.1136/gutjnl-2012-302254. Epub 2012 May 12.

  PMID: 22580412 BACKGROUND

• Georgopoulos SD, Xirouchakis E, Martinez-Gonzales B, Zampeli E, Grivas E, Spiliadi C, Sotiropoulou M, Petraki K, Zografos K, Laoudi F, Sgouras D, Mentis A, Kasapidis P, Michopoulos S. Randomized clinical trial comparing ten day concomitant and sequential therapies for Helicobacter pylori eradication in a high clarithromycin resistance area. Eur J Intern Med. 2016 Jul;32:84-90. doi: 10.1016/j.ejim.2016.04.011. Epub 2016 Apr 28.

  PMID: 27134145 BACKGROUND

MeSH Terms

Conditions

Gastritis

Interventions

Clarithromycin; Metronidazole; Esomeprazole

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of GI Department, PhD, MD

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 19, 2018
• Study Start: February 21, 2018
• Primary Completion: October 21, 2020
• Study Completion: January 31, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Locations

GR (1)