Evaluation of the efficacy of antibiotic therapy combined with corticosteroids in severe alcoholic hepatitis - AntibioCOR- HAA

Centre Hospitalier Régional et Universitaire de Lille0 个研究点目标入组 280 人开始时间: 2016年6月16日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- Patients aged 18-75
•- Recent onset of jaundice (<3 months)
•- Biopsy proven alcoholic hepatitis (transjugular liver biopsy)
•- Maddrey’s discriminant function above 32, defining severe alcoholic hepatitis
•- MELD score =21
•- Alcohol consumption of more than 40g/day (women) and 50g/day (men)
•- Written informed consent
•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 240
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Previous severe allergy or hypersensitivity to amoxicillin or clavulanic acid (anaphylactic shock, Quincke edema, severe urticaria)
•- Hypersensitivity to any component of the medication
•- History of liver injury to amoxicillin and/or clavulanic acid
•- Phenylketonuria, because of the presence of aspartame in the powder for the oral suspension
•- Type 1 hepatorenal syndrome before the initiation of treatment
•- Severe extrahepatic disease
•- Any malignant tumor < 2 years
•- Uncontrolled gastrointestinal bleeding
•- Ongoing viral or parasitic infection
•- Untreated bacterial infection.
•- Withdrawal from any antibiotic treatment less than 7 days. Patients who are currently being treated or were previously treated with antibiotics* for diagnosed infection or after a positive screening for infection may be included after wash-out period of 7 days (time from withdrawal of antibiotics to randomization).
•- Tuberculosis < 5 years
•- Positive blood PCR in patients with positive antibodies against HCV
•- Patient carrying HBV or HIV
•- Treatment with corticosteroids, immunosuppression therapy or budesonide within 6 months before the study
•-pregnant/nursing woman
•*use of beta-lactams is preferred, when considering a low accumulation in the body

发起方

Centre Hospitalier Régional et Universitaire de Lille