TABLE 12.
Randomized trials assessing meropenem-vaborbactam
| Trial ID (reference) | Comparatora | Phase | Designb | No. of patients randomized | Indicationc | Exclusion of immunocompromised patients | Outcomesd
|
|
|---|---|---|---|---|---|---|---|---|
| No. (%) | Risk difference (95% CIs) | |||||||
| Wunderink 2018 (193) | BAT | 3 | Noninferential | 77 | CRE infections: cUTI, cIAI, BSI, or NP | Immunocompromised allowed | Mortality: 1/32 (3.1) vs 5/15 (33.3) | −29.0 (−54.3 to −3.7) |
| Clinical cure TOC: 19/32 (59.4) vs 4/15 (26.7) | 32.7 (4.6 to 60.8) | |||||||
| Microbiol cure TOC: 17/32 (53.1) vs 5/15 (33.3) | 19.8 (−9.7 to 49.3) | |||||||
| Kaye 2018 (189) | PIP-TAZ | 3 | NI | 550 | cUTI | Organ transplant; HIV (CD4 <200/mm3); chemotherapy; immunosuppressive therapy; neutropenia <1,000/mm3 | Mortality: 2/272 (0.7) vs 2/273 (0.7) | |
| Clinical cure TOC: 174/192 (90.6) vs 157/182 (86.3) | 4.4 (−2.2 to 11.1) | |||||||
| Microbiol response TOC: 132/192 (68.8) vs 113/182 (62.1) | 6.7 (−3.0 to 16.2) | |||||||
a
BAT, best available therapy, including monotherapy or any combination of carbapenem, aminoglycoside, polymyxin B, colistin, tigecycline, or ceftazidime-avibactam; PIP-TAZ, piperacillin-tazobactam.
b
NI, noninferiority.
c
CRE, carbapenem resistant Enterobacterales; cUTI, complicated urinary tract infection; cIAI, complicated intra-abdominal infection; NP, nosocomial pneumonia; BSI, bloodstream infection.
d
TOC, test of cure; microbiol, microbiological.