Please select the arm or intervention descriptions that belong 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: Arm Label: Standard blood culture and AST; Type: ACTIVE_COMPARATOR; Interventions: Device: Standard Culture and AST | Arm Label: Rapid organism identification and AST; Type: ACTIVE_COMPARATOR; Interventions: Device: Accelerate PhenoTest™ BC Kit | Intervention Type: DEVICE; Name: Accelerate PhenoTest™ BC Kit; Assigned to Arm(s): Rapid organism identification and AST | Intervention Type: DEVICE; Name: Standard Culture and AST; Assigned to Arm(s): Standard blood culture and AST
B: Arm Label: Pathogen detection by Multiplex PCR; Type: ACTIVE_COMPARATOR; Interventions: Other: Antibiotic regimen | Arm Label: Pathogen detection by blood culture; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Antibiotic regimen; Assigned to Arm(s): Pathogen detection by Multiplex PCR
C: Arm Label: betaLACTA® result given to physician; Type: EXPERIMENTAL; Interventions: Device: betaLACTA® rapid diagnostic test | Arm Label: betaLACTA® result NOT given to physician; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: betaLACTA® rapid diagnostic test; Assigned to Arm(s): betaLACTA® result given to physician
D: Arm Label: Control; Type: EXPERIMENTAL; Interventions: Other: Bacterial culture, Other: Susceptibility testing | Arm Label: FilmArray test; Type: EXPERIMENTAL; Interventions: Device: FilmArray testing, Other: Bacterial culture, Other: Susceptibility testing | Arm Label: FilmArray plus antimicrobial stewardship; Type: EXPERIMENTAL; Interventions: Device: FilmArray testing, Behavioral: Antimicrobial Stewardship, Other: Bacterial culture, Other: Susceptibility testing | Intervention Type: DEVICE; Name: FilmArray testing; Assigned to Arm(s): FilmArray plus antimicrobial stewardship, FilmArray test | Intervention Type: BEHAVIORAL; Name: Antimicrobial Stewardship; Assigned to Arm(s): FilmArray plus antimicrobial stewardship | Intervention Type: OTHER; Name: Bacterial culture; Assigned to Arm(s): Control, FilmArray plus antimicrobial stewardship, FilmArray test | Intervention Type: OTHER; Name: Susceptibility testing; Assigned to Arm(s): Control, FilmArray plus antimicrobial stewardship, FilmArray test

Answer: C