Clinical trial NCT02935010: Tailored Versus Empiric Therapy for Helicobacter Pylori Treatment
Official title: Efficacy of Antibiotic Susceptibility-based Tailored Versus Empiric Therapy for Helicobacter Pylori First-line Treatment：a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Bismuth quadruple therapy
Tailored therapy
Empiric therapy
clarithromycin susceptibility
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: within 7 days after completion of therapy
measure: Compliance rate
timeFrame: within 7 days after completion of therapy
Other outcomes:
measure: Medical cost per patient of tailored or empiric therapy
timeFrame: two months after completion of therapy
measure: Ratio of medical cost to H. pylori eradication rate of each therapy
timeFrame: two months after completion of therapy
measure: Ratio of incremental medical cost to incremental H. pylori eradication rate of tailored compared with empiric therapy
timeFrame: two months after completion of therapy
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital, Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong Lu, M.D.
role: STUDY_CHAIR
affiliation: Ruijin Hospital
name: Yunwei Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Hong Gao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Tenth People's Hospital, Tongji University
name: Yan Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai General Hospital, Shanghai First People's Hospital, Shanghai Jiao Tong University
name: Gang Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: