Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness: A Pilot RCT

We will consider the main trial to be feasible and worthy of embarking on a larger mortality-powered RCT if 90% of antibiotic treatment courses are within 7± 2 days in the shorter duration treatment arm or 14 ± 2 days in the longer duration treatment arm.

We will consider the main trial to be feasible if we achieve recruitment rates of at least 1 patient per 4 weeks, on average, per participating site.

Defined as the recurrence of bacteremia due to original infecting organism (same Genus and species) after documentation of negative blood cultures or clinical improvement and within 30 days after completing course of adequate antimicrobial therapy.

Effect of medication on body that produces the allergic reaction to a medication like:

• Hives
• Itching of the skin or eyes
• Skin rash
• Swelling of the lips, tongue, or face
• Wheezing

To be considered anaphylaxis, the patient must have had >=1 of the following 3 criteria that a medical team member attributed to an Antimicrobial

• Acute onset of skin or mucosal tissue changes (hives, itching/flush, lip/tongue/uvula swelling) over minutes/hours, accompanied by

• respiratory compromise (dyspnea, wheeze, stridor, hypoxemia), AND/OR
• reduced blood pressure or symptoms/signs of end organ dysfunction from shock
• Rapid onset of two or more of the following

• involvement of the skin-mucosa (hives, itch//flush, swollen lips/tongue/uvula)
• respiratory compromise
• reduced BP or associated symptoms/signs
• persistent gastrointestinal symptoms/signs (crampy abdominal pain, vomiting)
• Reduced blood pressure after exposure to a known allergen for that patient

To be considered Antimicrobial-associated renal injury, a medical team member must have attributed the renal injury to the Antimicrobial, and the severity of the renal injury must meet one of these (RIFLE criteria):

• Risk: GFR decrease >25%, serum creatinine increased 1.5 times or urine production of <0.5 ml/kg/hr for 6 hours
• Injury: GFR decrease >50%, doubling of creatinine or urine production <0.5 ml/kg/hr for 12 hours
• Failure: GFR decrease >75%, tripling of creatinine or creatinine >355 μmol/l (with a rise of >44) (>4 mg/dl) OR urine output below 0.3 ml/kg/hr for 24 hours
• Loss: persistent AKI or complete loss of kidney function for more than 4 weeks
• End-stage renal disease: need for renal replacement therapy (RRT) for more than 3 months

To be considered Antimicrobial-associated hepatitis, a medical team member must have attributed the hepatitis to the Antimicrobial, and the severity of the hepatitis must meet this FDA criteria for hepatic adverse events:

o ALT> 3x the upper limit of normal

Defined as a positive PCR or ELISA test for Clostridium difficile toxin in the context of diarrhea within hospital of bacteremia diagnosis.

Defined as the number of consecutive days receiving invasive (via an endotracheal tube or tracheostomy), or non-invasive (via a facemask, nasal mask, or helmet) ventilation. Durations will be calculated for all patients then separately for patients who died within hospital and those who did not die.

Defined as the number of consecutive days receiving intravenous vasoactive medications (e.g. epinephrine, norepinephrine, vasopressin, dopamine, phenylephrine, dobutamine, milrinone). Durations will be calculated for all patients then separately for patients who died within hospital and those who did not die.