mechanically ventilated patients
Conditions
Interventions
Pharmaceutical Form:
INN or Proposed INN: Amoxicillin Trihydrate
Other descriptive name: AMOXICILLIN TRIHYDRATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 875
Sponsors
Charité-Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 = 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
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of the trial is to study the effect of antibiotic therapies on pulmonary immunoglobulin A (IgA) in mechanically ventilated patients. Based on data from mouse models and a pilot study from our research group, we assume that antibiotic therapies reduce pulmonary IgA level.;Secondary Objective: Secondary objectives of the trial are the investigation of the effect of antibiotic therapies on other immune parameters in lung and serum as well as in saliva and on the respiratory and intestinal microbiota and the incidence of ventilator-associated infections and hospitalisation time.;Primary end point(s): pulmonary IgA as measured in broncheoalveolar lavage fluid (BALF);Timepoint(s) of evaluation of this end point: single measure on day 0-2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total bacterial load and diversity of respiratory and intestinal microbiota metagenomic sequencing of bacterial DNA of selected probes to analyse microbiota composition on species- or strainlevel IgA in saliva, tracheobronchial fluid, bronchial lavage fluid and serum IgG and IgM in BALF and serum immune cells in BALF and serum cytokines in BALF and Serum Expression Profile of alveolar macrophages relative frequency of ventilator-associated infections relative frequency of coloniazation of the respiratory tract with multi drug resistant bacteria relative frequency of SAE/AE ;Timepoint(s) of evaluation of this end point: Total bacterial load and diversity of pulmonary and intestinal microbiota - singe neasure day 0-2 IgA in saliva, tracheobronchial lavage and serum - single measure day 0-2 IgG and IgM in BAL and serum - single measure day 0-2 cytokines in BAL and serum - single measure day 0-2 immune cells in BAL and serum- single measure day 0-2 cytokines in BAL and serum - single measure day 0-2 relative frequency of ventilator-associated infections- day 30 and 90 relative frequency of coloniazation of the respiratory tract with multi drug resistant bacteria - day 30 and 90 total length of hospitalization - day 30 and 90 relative frequency of SAE/AE- day 1-3 | — |
Countries
Germany
Contacts
Public ContactAG Klinische Studien
Charité Universitätsmedizin Berlin
Outcome results
None listed