Influence of antibiotics on microbiota, immune response and incidence of ventilator-associated infections
- Conditions
- Z99.1Dependence on respirator
- Registration Number
- DRKS00017081
- Lead Sponsor
- Charité Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
patients informed consent;
age = 18 years;
negative result of pregnancy 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
AND EITHER
=90 no antibiotic therapy
OR
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 24-72h before 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.
• Tobramycin i.v.
• Trimethoprim/ Sulfamethoxazol (Cotrimoxazol) p.o. und i.v.
• Vancomycin i.v.
• 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 bronchoscopy 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
• shock
• 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary immunoglobuline A<br>Time point: Day 1 of participation in the trial<br>method: ELISA (Enzyme-linked Immunosorbent Assay) from broncheoalveolar lavage fluid
- Secondary Outcome Measures
Name Time Method Pulmonary and intestinal microbiota (total bacterial load and composition); immunoglobuline A in serum