Please select the eligibility criteria that correspond to the clinical trial below.
Title: BetaLACTA® Test-guided Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections Diagnosed in Intensive Care Unit - BLUE¬-CarbA Study
Brief Summary: The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems, particularly in the most fragile patients such as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of carbapenem resistance mechanisms. Moreover, several preliminary results suggest that carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of carbapenem exposure is widely desired both by national and international antibiotic plans. Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce inappropriate exposure to carbapenems could be a relevant solution. Due to its good diagnostic performance, the betaLACTA® test could meet these objectives.

Experimental plan :

Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic medical device (close to a phase III study), comparing two parallel groups:

* Experimental group: early carbapenems de-escalation since the second dose, guided by results of the betaLACTA® test performed directly on the bacterial pellet from the microbiological sample positive on direct examination.
* Control group: carbapenems de-escalation guided by definitive results of the antibiotic susceptibility test obtained 48 to 72h after microbiological sampling (reference strategy).


Options:
A: Inclusion Criteria:

* Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.

Exclusion Criteria:

* Identification of GNB outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
* Positive blood culture for GNB at the same institution within prior 7 days (if known at the time of randomization).
* Deceased at the time of randomization.
* GNB plus gram-positive organism, gram-negative cocci, and/or yeast detected on Gram stain
* Previous enrollment in this study
* No Minnesota research authorization (Rochester site only)
B: Inclusion Criteria:

* Patient 18 or more years old
* Patient staying more than 48 hours in hospital
* Patient with clinical suspicion of infection and presenting at leat two of the following criteria:temperature \> 38oC or \< 36oC, heart rate \> 90 beats/minute, respiratory rate \> 20 breaths/minute or PaCO2 \< 32 mmHg or leukocytosis \>12 000/μl or leukopenia \<4000/μl or normal white blood cell count with \>10% immature forms
* Patient or responsible able to provide informed consent

Exclusion Criteria:

* Patient submitted to cardiovascular surgery in the last fifteen days
* Patient or responsible are not able to provide informed consent
C: Inclusion Criteria:

* ICU patients ≥18 years.
* With a suspected pneumonia (according to CPIS definition), primary blood-stream infection (according to CDC definition), and/or urinary tract infection (according to IDSA Guidelines).
* And presence of ≥2 GNB/field on direct examination of a respiratory sample (quantitative bronchial aspirate with an available volume ≥ 1mL), urinary sample or blood culture.
* Leading to an empirical carbapenem prescription, not administered for more than 6 hours when considering the inclusion of the patient.
* Written informed consent signed by the patient / the trustworthy person / the next-of-kin / close relative, or inclusion in case of emergency and written informed consent will been signed by the patient as soon as possible.
* Patients affiliated to French social security.

Exclusion Criteria:

* Pregnancy.
* Allergy to beta-lactams.
* Patients already treated with ongoing carbapenems for another documented infection, blocking carbapenem de-escalation.
* Patients included in another interventional study.
* Patients in whom a procedure of withdrawing life-sustaining treatment was decided before inclusion.
* Moribund patients.
* Patients with aplasia.
* Patients under tutorship/curatorship or patient deprived of freedom
D: Inclusion criteria:

* Positive blood culture during the study period.
* No positive blood cultures in prior 7 days
* Minnesota state research authorization provided

Exclusion criteria:

* No Minnesota state research authorization
* Deceased or transitioned to comfort care within 24 hours of enrollment
* Positive blood culture in prior 7 days
* Previously enrolled in this study
* Negative Gram stain

Answer: C