EUCTR2018-000492-32-DE进行中（未招募）1 期
Effects of antibiotics on micobiota, pulmonary immune response and incidence of ventilator-associated infections - AMIII
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •patients informed consent
- •age = 18 years
- •negative result of pregnany test in women of childbearing potential (WOCBP)
- •no participation in other clinical trials 30 days prior and after
- •on the day of enrolment at least intermittendly mechanical ventilation via tracheostomy
- •on the day of enrolment, hospitalization at Charité University hospital for at least 24hrs
- •state of clinical stability or state of clinical improvement with very high likelihood of development of a state of clinical stability
- •=90 no antibiotic therapy
- •on the day of inclusion completed course of antibiotic therapy that fulfills all of the following criteria:
- •7-10 days of antibiotic therapy with antimicrobial activity against Gram-negative, Gram-positive and anaerobic bacteria
- •Treatment according to marketing authorisation
- •Treatment according to SmPC
- •Treatment with trade product holding a marketing authorisation in original package
- •Treatment ended = 5x elimination half-time of the trade product prior AND not more than 72hrs prior to inclusion
- •Treatment with at least one of the following active substances (alphabetic order, same order as in Modul 1)
- •Amoxicillin/Clavulansäure p.o.
- •Ampicillin/Sulbactam i.v.
- •Cefazolin i.v.
- •Cefepim i.v.
- •Ceftazidim i.v.
- •Ceftazidim/Avibactam i.v.
- •Ceftolozan/Tazobactam i.v.
- •Ceftriaxon i.v.
- •Ciprofloxacin p.o. oder i.v.
- •Clarithromycin p.o. oder i.v.
- •Clindamycin p.o. oder i.v.
- •Daptomycin i.v.
- •Ertapenem i.v.
- •Flucloxacillin i.v.
- •Gentamicin i.v.
- •Imipenem i.v.
- •Linezolid p.o. und i.v.
- •Meropenem i.v.
- •Metronidazol p.o. oder i.v.
- •Piperacillin/Tazobactam i.v.
- •- Tigecyclin i.v.
- •Tobramycin i.v.
- •Trimethoprim/ Sulfamethoxazol (Cotrimoxazol) p.o. und i.v.
- •Vancomycin i.v.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •pregnancy and breastfeeding
- •instable clinical Situation
- •use of IMP not according to SmPC
- •active pneumonia, that is not fully treated on day of inclusion
- •current acute exacerbation of Asthma bronchiale or COPD
- •confirmed diagnosis on day of enrolment of congenital or acquired immune deficiency
- •current immunosuppressive therapy and/or = 3 months prior to enrolment (in case of corticosteroids = 20mg prednisolone/d or equivalent)
- •current chemotherapy and/or = 3 months prior to enrolment
- •confirmed diagnosis or high clinical suspicion of hematological malignancy including myelodisplastic syndrome, chronic lymphocytic leukaemia or multiple myeloma
- •Crohn's disease or ulcerative colitis
- •confirmed diagnosis of Clostridium difficile Enteritis
- •confirmed diagnosis on day of enrolment of cystic fibrosis
- •confirmed diagnosis on day of enrolment of open lung tuberculosis
- •confirmed diagnosis on day of enrolment of advanced stage lung cancer (stage III/IV)
- •middle or high risk of bronchoskopy as judged by investigating physician
- •all contraindications against medication or adjuvants used for analdosedation during bronchoscopy, in detail
- •against midazolam:
- •hypersensitivity against midazolam
- •acute respiratory failure
- •against propofol:
- •hypersensitivity against propofol or one of the adjuvants, such as soy allergy
- •against lidocain:
- •hypersensitivity against lidocain
- •acute heart failure
- •severe uncontrolled cardiac arrythmia
- •missing consent for storage and transfer of data within the clinical study
- •participation in another clinical trial within 30 days prior or currently
- •previous participation in this study
- •hospitalisation ordered by court
研究者
相似试验
招募中
不适用
The effect of IV antibiotics on gut flora during an episode of fever in children with cancer.Systemic antibiotics, microbiota, pediatric patients with cancer, febrile neutropenia.NL-OMON21552niversity Medical Centre Groningen20
招募中
4 期
Influence of antibiotics on microbiota, immune response and incidence of ventilator-associated infectionsZ99.1Dependence on respiratorDRKS00017081Charité Universitätsmedizin Berlin40
已完成
不适用
Microbiome changes due to antibiotic prophylaxis in mothers at birthMicrobiome examination after cesarean section or vaginal delivery, respectivelyDRKS00027305Kliniken der Stadt Köln gGmbH37
尚未招募
不适用
Effect antibiotics on gutmicrobiota composition & insulin resistance.insulin resistance, obesityNL-OMON24894Academic Medical Center, Amsterdam20
尚未招募
不适用
Influences of antibiotics on biodiversity of intestinal microbiota in newbornsintestinal floraMicrobiota1001796610004018NL-OMON33555niversitair Medisch Centrum Groningen50