Pilot Feasibility and Non-inferiority Study of a Strategy for the Detection and Treatment of Helicobacter Pylori Infections in Primary Care Guided by a Non-invasive Technique for the Detection of Helicobacter Pylori Infection and Clarithromycin Resistance by PCR Real Time in the Stool
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 245
- 试验地点
- 26
- 主要终点
- Cure rate assessed by the result of a urea breath test carried out 6 weeks after the end of treatment (proof of Hp eradication)
研究概览
简要总结
In France, every year 1 million people are explored for Helicobacter pylori infection and 200,000 receive eradication treatment. Faced with the high prevalence of Hp resistance to antibiotics, the Haute Autorité de Santé (HAS) has recommended since 2017 a treatment strategy guided by the results of bacteriological tests (culture and antibiogram and / or PCR) carried out from gastric biopsies. Guided therapy is more effective, cheaper, and better tolerated than empiric therapy (it includes fewer antibiotics). But the guided treatment is not used despite the recommendations because of the invasive nature of the endoscopy, the difficulty of culture and the non-reimbursement of the PCR. A new non-invasive test by real-time PCR performed on the stools of patients makes it possible to detect the Hp infection and its sensitivity to clarithromycin and therefore to guide the treatment with excellent performance as we have been able to demonstrate during a study including 1200 patients (Pichon et al J Clin Microbiol 2020). These characteristics allow this test to be used in primary care but has to be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person over 18 years old
- •Patient affiliated or beneficiary of a social security scheme.
- •Informed consent signed by the patient after clear and fair information about the study
- •Patient registered on the list of patients who signed a doctor's statement with the investigating doctor.
- •Patient with an indication for research and treatment of an Hp infection according to National Health Authority (HAS) recommendations:
- •Suffering from (at least one) : Chronic dyspepsia; Iron deficiency anemia without a found cause or resistant to iron supplementation; Vitamin B12 deficiency without a found cause; familial gastric cancer DCDS; Immunological thrombocytopenic purpura in adulthood; history of peptic ulcers or precancerous lesions that have not been eradicated; Long-term consumption of NSAIDs; Long-term PPI consumption.
- •Patient who received Hp eradication treatment without eradication control. or
- •Patient with risk factors for gastric cancer: person related to a patient who has had stomach cancer (parents, brothers / sisters, children).
- •Patient with a syndrome of predisposition to digestive cancers (Hereditary non-polyposis colorectal carcinoma cancer HNPCC / Lynch syndrome).
- •Patient who has had a partial gastrectomy or endoscopic treatment of gastric cancerous lesions.
- •Patient with pre-neoplastic gastric lesions (severe atrophy and / or intestinal metaplasia, dysplasia).
- •Patient who has already undergone an endoscopy with detection of Hp but without antibiotic sensitivity test (biopsy not addressed in bacteriology) and for whom we want to undergo a guided treatment.
排除标准
- •Patient benefiting from enhanced protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection and finally patients in emergency situations.
- •Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy).
- •Exclusion criteria related to non-compliance with ambivalence:
- •Allergy to amoxicillin (suspected or documented).
- •Contraindication to eso-gastro-duodenal fibroscopy and biopsies.
- •Use of antibiotic within 15 days before enrolment.
- •Patient with an indication to perform an endoscopy of the upper digestive system in Emergency according to the criteria of "the European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE II)": upper gastrointestinal hemorrhage; acute deglobulization without digestive hemorrhage externalized; ingestion of caustics; acute dysphagia or ingestion of foreign bodies.
- •Participating another interventional trial
研究组 & 干预措施
new strategy experimental
Patients receive a prescription for an Hp serology and a stool self-collection kit. Only the results of the PCR test in the stool will be considered for this arm. The analysis of the stool sample using multiplex PCR will determine the presence of a Hp infection. If positive, patients are treated for eradication.
干预措施: PCR test in the stool (Diagnostic Test)
National Health Authority (HAS) strategy control
Patients receive a prescription for Hp serology and a stool self-sampling kit. Only the results of the serology will be considered for this arm. The anatomopathological and/or bacteriological analyses will determine the presence of a Hp infection. If positive, patients are treated for eradication.
干预措施: PCR test in the stool (Diagnostic Test)
National Health Authority (HAS) strategy control
Patients receive a prescription for Hp serology and a stool self-sampling kit. Only the results of the serology will be considered for this arm. The anatomopathological and/or bacteriological analyses will determine the presence of a Hp infection. If positive, patients are treated for eradication.
干预措施: Hp serology and gastroscopy (Diagnostic Test)
new strategy experimental
Patients receive a prescription for an Hp serology and a stool self-collection kit. Only the results of the PCR test in the stool will be considered for this arm. The analysis of the stool sample using multiplex PCR will determine the presence of a Hp infection. If positive, patients are treated for eradication.
干预措施: Hp serology and gastroscopy (Diagnostic Test)
结局指标
主要结局
Cure rate assessed by the result of a urea breath test carried out 6 weeks after the end of treatment (proof of Hp eradication)
时间窗: up to 4 months
Proportion of patients with a negative urea breath test (proof of Hp eradication)
时间窗: up to 4 months after inclusion
Urea breath test is carried out 6 weeks after the end of treatment
次要结局
未报告次要终点