Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

NCT04621487 | Completed DMC

• 1 other identifier: 004/08-19-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• eradication

  H.pylori status will be tested 1 month after therapy with a stool antigen test: positive or negative

  1 month after finishing therapy

Secondary Outcomes (2)

• compliance

  1 month after finishing therapy

• adverse event

  1 month after finishing therapy

Study Arms (2)

concomitant

ACTIVE COMPARATOR

Concomitant therapy consists of 14 days pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, metronidazole 500 mg all twice daily.

Drug: Amoxicillin; Drug: Metronidazole; Drug: Clarithromycin; Drug: Pantoprazole 40mg

tailored

ACTIVE COMPARATOR

Tailored therapy consists of 14 days antibiotic therapy according to H. Pylori strains antibiotic sensitivity test together with pantoprazole 40 mg twice daily.

Drug: according to antibiogram

Interventions

Metronidazole DRUG

14 days 500 mg bid

concomitant

Amoxicillin DRUG

14 days 1 gr bid

concomitant

Clarithromycin DRUG

14 days 500 mg bid

concomitant

Pantoprazole 40mg DRUG

40 mg bid 14 days

Also known as: Pantoprazole

concomitant

according to antibiogram DRUG

according to antibiogram

tailored

Eligibility Criteria

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

You may qualify if:

• helicobacter pylori infection

You may not qualify if:

• previous unsuccessful eradication treatment, stomach or other malignancy, taking of proton pump inhibitors, H2-antagonists, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in the previous month, significant comorbidities (renal insufficiency, psychiatric disease), denial to participate in the study, history of allergy to proton pump inhibitors or antibiotics, pregnancy and lactation.

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University hospital Split

Split, 21000, Croatia

Location

MeSH Terms

Interventions

Amoxicillin; Metronidazole; Clarithromycin; Pantoprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Erythromycin; Macrolides; Polyketides; Lactones; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles

Study Officials

• Nikola Perkovic, MD

  University Hospital of Split

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: November 9, 2020
• Study Start: January 15, 2019
• Primary Completion: January 15, 2020
• Study Completion: February 15, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)