TABLE 8.
Randomized controlled trials assessing TOL-TAZ efficacy outcomes
| Trial ID (reference) | Comparatora | Phase | Designb | No. randomized | Indicationc | Exclusion of immunocompromised patients | Outcomesd
|
|
|---|---|---|---|---|---|---|---|---|
| No. (%) interventions vs control | Risk difference (95% CIs) | |||||||
| Kollef 2019 (140) | Mero | 3 | NI | 726 | NP | Organ transplant; HIV (CD4 <200/mm3); Immunosuppressive therapy; neutropenia | Mortality: 87/362 (24.0) vs 92/364 (25.3) | 1.1 (−5.1 to 7.4) |
| Clinical cure TOC: 197/362 (54.4) vs 194/364 (53.3) | 1.1 (−6.2 to 8.3) | |||||||
| Microbiol response TOC: 193/264 (73.1) vs 168/247 (68.0) | 4.5 (−3.4 to 12.5) | |||||||
| Lucasti 2014 (141) | Mero | 2 | Noninferential | 122 | cIAI | Immunocompromising illness; neutropenia <1,000/mm3 | Mortality: 3/61 vs 0/25 | |
| Clinical cure TOC: 51/61 (83.6) vs 24/25 (96.0) | −12.4 (−34.9 to 11.1) | |||||||
| Microbiol response TOC: 48/53 (90.6) vs 23/24 (95.8) | ||||||||
| Solomkin 2015 (142) | Mero | 3 | NI | 993 | cIAI | No | Mortality: 11/482 (2.3) vs 8/497 (1.6) | |
| Clinical cure TOC: 323/389 (83.0) vs 364/417 (87.3) | ||||||||
| Wagenlehner 2015 (143) | Levo | 3 | NI | 1,083 | cUTI | Organ transplant; AIDS; chemotherapy; immunosuppressive therapy; neutropenia <500/mm3 | Mortality: 1/543 vs 0/540 | |
| Clinical cure TOC: 366/398 (92.0) vs 356/402 (88.6) | 3.4 (−0.7 to 7.6) | |||||||
| Microbiol response TOC: 320/398 (80.4) vs 290/402 (72.1) | 8.3 (2.4 to 14.1) | |||||||
a
Mero, meropenem; Levo, levofloxacin.
b
NI, noninferiority.
c
cUTI, complicated urinary tract infection; cIAI, complicated intra-abdominal infection; NP, nosocomial pneumonia.
d
CI, confidence intervals; TOC, test of cure; microbiol, microbiological.