Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy

Sponsor

Sir Run Run Shaw Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02894268

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Doxycycline Drug: Furazolidone Drug: Esomeprazole Drug: Colloidal Bismuth Subcitrate Drug: Sensitivity antibiotics	Phase 4

Detailed Description

This study is a prospective, multiple centers, randomized trial. Patients who had failed in previous H. pylori eradication treatment that more than two times will be enrolled in Sir Run Run Shaw Hospital.

Pretreatment H. pylori status will be defined by a positive 13 C-urea breath test (13 C-UBT). Patients who had received bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before 13 C-UBT are excluded. Other exclusion criteria included upper gastrointestinal surgery, malignancy, and evidence of blood dyscrasia.

After the patient is enrolled the patient will sign the informed consent and receive gastroscopy. More than four biopsy will be given including two in antrum and two in gastric body. One pair of biopsy sample will be sent for the pathology and the other pair is used for H.pylori culture and antibiotics sensitivity. After we get the result of antibiotics sensitivity the patient will be divided randomly into two groups, Regimen A, Regimen B.

The Regimen A includes esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg . All drugs are taken twice a day for 14 days. The Regimen B includes two antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg. The esomeprazole and bismuth are taken half an hour before a meal and antibiotics after the meal.

All patients are asked to quit smoking and drinking and forbid eating foods rich in tyramine (e.g., chicken, cheese, pickles, lentils, beans) and seafood during and in 1 week after the treatment.

Patients will be followed up at the 1st day, 14th day, and 4 weeks after the treatment, respectively, and all side effects will be collected.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy

Actual Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Regimen A esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg	Drug: Doxycycline Doxycycline 100g po bid Other Names: Vibramycin Drug: Furazolidone Furazolidone 100mg po bid Other Names: Giarlan Drug: Esomeprazole Esomeprazole 20mg po bid Other Names: Nexium Drug: Colloidal Bismuth Subcitrate Bismuth 20mg po bid Other Names: PIDI
Active Comparator: Regimen B two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg	Drug: Esomeprazole Esomeprazole 20mg po bid Other Names: Nexium Drug: Colloidal Bismuth Subcitrate Bismuth 20mg po bid Other Names: PIDI Drug: Sensitivity antibiotics Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.

Arm

Intervention/Treatment

Experimental: Regimen A

esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg

Drug: Doxycycline

Doxycycline 100g po bid

Other Names:

Vibramycin

Drug: Furazolidone

Furazolidone 100mg po bid

Other Names:

Giarlan

Drug: Esomeprazole

Esomeprazole 20mg po bid

Other Names:

Nexium

Drug: Colloidal Bismuth Subcitrate

Bismuth 20mg po bid

Other Names:

PIDI

Active Comparator: Regimen B

two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg

Drug: Esomeprazole

Esomeprazole 20mg po bid

Other Names:

Nexium

Drug: Colloidal Bismuth Subcitrate

Bismuth 20mg po bid

Other Names:

PIDI

Drug: Sensitivity antibiotics

Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.

Outcome Measures

Primary Outcome Measures

H. pylori eradication rate [42 days after start of therapy]
Repeat 13-Urea breath test 42 days after H.pylori eradication

Secondary Outcome Measures

Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment [14 days and 42 days after H.pylori eradication]
Number of participants whose symptoms disappear or improve after eradication treatment.
Side effects [14 days after start of therapy]
Adverse Events That Are Related to Eradication Treatment
Adherence rate [14 days after start of therapy]
Number of patients who take at least 80% drugs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

A positive 13 C-urea breath test
Formal H.pylori treatment more than two times
Age >18 years

Exclusion Criteria:

Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
Allergic to the medications
Upper gastrointestinal surgery history
Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
Evidence of blood dyscrasia
Pregnant and lactating women
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