EUCTR2016-001916-39-IT进行中（未招募）1 期
A phase IV, single-blind, randomized, controlled, single-center study evaluating the efficacy of amoxicillin+clavulanic acid Vs no treatment in preventing complications after tooth extraction and the efficacy of a probiotic in preventing antibiotic adverse effect - AB0001
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Female and male patients seeking Oral Dental Care at UO Odontostomatologia e Chirurgia del Cavo Orale” and needing dental extractions due to an ongoing infection.
- •- Adult patients (=18 year old)
- •- Subjects capable of giving informed consent
- •- Subjects who are women of childbearing potential must agree to utilize a highly effective contraceptive measure throughout the course of the study for the entire duration of the trial and the subsequent 60-day follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Patients requiring third molar extractions
- •- General contraindications to oral surgery
- •- Immunosuppressed or immunocompromised patients
- •- Patients under therapy with aminobisphosphonates i.v
- •- Head and neck irradiation
- •- Pregnancy and breastfeeding
- •- Uncontrolled diabetes
- •- Patients suffering from infectious mononucleosis
- •- Patients suffering from colitis
- •- Patients suffering from renal failure
- •- Patients having drug and alcohol dependence
- •- Psychiatric disorders that contraindicate oral surgery
- •- Allergy both to penicillin, or other beta-lactams, and probiotic
- •- Hypersensitivity to active ingredient and to all penicillins
- •- History of severe immediate hypersensitivity reactions (e.g. anaphylaxis) to other beta-lactam agents (e.g. cephalosporins, carbapenems, monobactams)
- •- Patients under therapy with methotrexate, probenecid, mycophenolate mofetil, allopurinol
- •- Patients with history of amox+clav-related jaundice/hepatic failure
- •- Patients with hyper-sensibility to stearate magnesium, sodium carboxymethylamid A, silica colloidal anhydrous, microcrystal cellulose, titanium dioxide (E171), hypromellose, Macrogol (4000-6000) and dimethicone;
- •- Patients under therapy with oral anticoagulants;
- •- Hypersensitivity to all excipients/substances in the probiotic
研究者
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