Studied in a multinational, double-blind trial vs imipenem-cilastatin in cUTI1

Assessments1,2

Clinical trial assessment timeline Fetroja vs imipenem/cilastatin primary efficacy endpoint TOC 7 days post therapy ± 2 days Clinical trial assessment timeline Fetroja vs imipenem/cilastatin primary efficacy endpoint TOC 7 days post therapy ± 2 days
  • Patients with cUTI ± pyelonephritis (N=448)1
  • Study was designed to capture a complicated patient population with comorbidities, who are at greater risk of multidrug-resistant Gram-negative infections2
    • Allowed immunosuppressed patients including renal transplant1
    • Limited patients with acute uncomplicated pyelonephritis to 30% maximum2
    • Step-down to oral therapy not permitted1
  • Randomized 2:1 to receive Fetroja (n=300) or imipenem/cilastatin (n=148) for 7-14 days
    • Dosages used were Fetroja 2 grams every 8 hours (infused over 1 hour*), imipenem/cilastatin 1 gram/1 gram every 8 hours (infused over 1 hour)1,2
    • High dosage of imipenem/cilastatin used to allow for inclusion of patients with P aeruginosa infection2
    • Carbapenem-resistant pathogens excluded as ethical necessity due to carbapenem comparator2
* Recommended dosing of Fetroja is 2 grams every 8 hours by intravenous (IV) infusion over 3 hours in patients with creatinine clearance (CLcr) ≥60 to <120 mL/min.1

Fetroja demonstrated significantly higher efficacy vs high-dose imipenem/cilastatin at TOC1,2

Primary endpointa: Composite clinical responseb and microbiological eradicationc at TOC

Fetroja 72.6 % (n=183/252); Imipenem/cilastatin 54.6% (n=65/119); Treatment difference 18.6% (95% CI, 8.2, 28.9) P=0.0004

CI=confidence interval; TOC=test of cure, 7±2 days after last dose of study drug.


Fetroja demonstrated significantly higher response rates vs high-dose imipenem/cilastatin in cUTI1

Secondary endpointsa

Secondary endpointsa: TOC1

Microbiologic eradicationc at TOC

Fetroja 73.0% (n=184/252); Imipenem/cilastatin 56.3% (n=67/119); Treatment difference 17.3% (95% CI, 6.9, 27.6)

Clinical responseb at TOC

Fetroja 89.7% (n=226/252); Imipenem/cilastatin 87.4% (n=104/119); Treatment difference 2.4% (95% CI, -4.7, 9.4)

Secondary endpointsa: Follow-up3

  • Composite of microbiological eradication and clinical response at follow-up: Fetroja 54.4% (n=137/252) vs imipenem/cilastatin 39.5% (n=47/119)
  • Treatment difference was 15.31% (95% CI, 4.69, 25.92)

Microbiologic eradicationc at follow-up

Fetroja 57.1% (n=144/252); Imipenem/cilastatin 43.7% (n=52/119); Treatment difference 13.92% (95% CI, 3.21, 24.63)

Clinical responseb at follow-up

Fetroja 81.3% (n=205/252); Imipenem/cilastatin 72.3% (n=86/119); Treatment difference 9.02% (95% CI, -0.37, 18.41)

Subgroup analyses

Subgroup analysis of composite endpoint by baseline pathogens1†
Baseline Pathogen Subgroup Fetroja % (n/N) Imipenem/cilastatin % (n/N)
E coli 74.3%
(113/152)
57.0%
(45/79)
K pneumoniae 75.0%
(36/48)
48.0%
(12/25)
P mirabilis 76.5%
(13/17)
0.0%
(0/2)
P aeruginosa 44.4%
(8/18)
60.0%
(3/5)
E cloacae complex 61.5%
(8/13)
100.0%
(3/3)
Patients may have been infected with more than one pathogen in the baseline urine culture.

Efficacy in subgroups was consistent with results in the overall population2

Subgroup analysis of composite endpoint at TOC in micro-ITT populationa
Treatment differences across subgroups by analysis population, age, sex, clinical diagnosis
4 patients had NDM-producing organisms in the Fetroja group; all 4 achieved clinical cure, with 3 also having eradication at TOC4

Among ESBL-producing pathogens at baseline, Fetroja achieved response in 62.9% (N=70) of patients vs 47.2% (N=36) for imipenem/cilastatin (16.66% treatment difference, 95% CI -3.08, 36.40) in composite endpoint at TOC2