Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02935010

Collaborator

(none)

382

Enrollment

Locations

Arms

13.8

Actual Duration (Months)

76.4

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of antibiotic sensitivity-based tailored therapy compared with empiric bismuth quadruple therapy in the naive patients with Helicobacter pylori infection.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Esomeprazole Drug: Bismuth Potassium Citrate Drug: Amoxicillin Drug: Clarithromycin Drug: Metronidazole Drug: Levofloxacin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

382 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial

Actual Study Start Date :

Feb 5, 2017

Actual Primary Completion Date :

Mar 31, 2018

Actual Study Completion Date :

Mar 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tailored therapy After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.	Drug: Esomeprazole proton pump inhibitor Drug: Bismuth Potassium Citrate Gastric mucosal protective drug with anti-H. pylori effect Drug: Amoxicillin antibiotic for H. pylori eradication Drug: Clarithromycin antibiotic for H. pylori eradication Drug: Metronidazole antibiotic for H. pylori eradication Drug: Levofloxacin antibiotic for H. pylori eradication
Active Comparator: Empiric therapy give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days	Drug: Esomeprazole proton pump inhibitor Drug: Bismuth Potassium Citrate Gastric mucosal protective drug with anti-H. pylori effect Drug: Amoxicillin antibiotic for H. pylori eradication Drug: Metronidazole antibiotic for H. pylori eradication

Arm

Intervention/Treatment

Experimental: Tailored therapy

After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid and two sensitive ones of amoxicillin,clarithromycin, metronidazole,and levofloxacin. All regimens will be given for 14 days.

Drug: Esomeprazole

proton pump inhibitor

Drug: Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

antibiotic for H. pylori eradication

Drug: Clarithromycin

antibiotic for H. pylori eradication

Drug: Metronidazole

antibiotic for H. pylori eradication

Drug: Levofloxacin

antibiotic for H. pylori eradication

Active Comparator: Empiric therapy

give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid, amoxicillin 1000mg tid and metronidazole 400mg tid for 14 days

Drug: Esomeprazole

proton pump inhibitor

Drug: Bismuth Potassium Citrate

Gastric mucosal protective drug with anti-H. pylori effect

Drug: Amoxicillin

antibiotic for H. pylori eradication

Drug: Metronidazole

antibiotic for H. pylori eradication

Outcome Measures

Primary Outcome Measures

Helicobacter pylori eradication rate [Six weeks after completion of therapy]
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).

Secondary Outcome Measures

Rate of adverse effects [within 7 days after completion of therapy]
During the 14-day treatment period, the subjects kept a diary to score any possible side effects or discomforts. The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities). The side effect score recorded was based on the most severe event.
Compliance rate [within 7 days after completion of therapy]
Compliance was deﬁned as poor when they had taken less than 80% of the total medication.

Other Outcome Measures

Medical cost per patient of tailored or empiric therapy [two months after completion of therapy]
Ratio of medical cost to H. pylori eradication rate of each therapy [two months after completion of therapy]
Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric therapy [two months after completion of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with non-ulcer functional dyspepsia or scarred peptic ulcer disease
Ability and willingness to participate in the study and to sign and give informed consent
confirmed H. pylori infection

Exclusion Criteria:

Previous H. pylori eradication therapy
Less than 18 years old
With history of H. pylori infection treatment
With previous gastric surgery
Major systemic diseases
Pregnancy or lactation
Allergy to any of the study drugs
Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200001
2	Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200001
3	Shanghai Tenth People's Hospital, Tongji University	Shanghai	Shanghai	China	200001
4	Zhongshan Hospital,Fudan University	Shanghai	Shanghai	China	200001
5	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai	China	200127

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

Study Chair: Hong Lu, M.D., Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Principal Investigator: Yunwei Sun, M.D., Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Principal Investigator: Hong Gao, M.D., Fudan University
Principal Investigator: Yan Zhao, M.D., Shanghai Tenth People's Hospital, Tongji University
Principal Investigator: Gang Xu, M.D., Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University