TABLE 6.
Randomized controlled trials assessing ceftazidime-avibactam efficacy outcomes
| Trial IDa; population (reference) | Comparatorb | Phase | Designc | No. randomized | Indicationd | Exclusion of immunocompromised patients | Outcomese
|
|
|---|---|---|---|---|---|---|---|---|
| No. (%; 95% CI) interventions vs control | Risk difference (95% CI) | |||||||
| Vazquez 2012; adults (313) | Imi | 2 | NS | 137 | cUTI | No | Clinical response TOC: 24/28 (85.7) vs 29/36 (80.6) | 5.2 (−16.3 to 26.6) |
| Microbiol response TOC: 19/27 (70.4) vs 25/35 (71.4) | −1.1 (−27.2 to 25.0) | |||||||
| Qin 2016; adults (85) | Mero | 3 | NI | 441 | cIAI | Neutropenia <1,000/mm3; renal transplant | Mortality: 2/215 (0.9) vs 1/217 (0.5) | |
| Clinical cure TOC: 166/177 (93.8) vs 173/184 (94.0) | −0.2 (−5.53 to 4.97) | |||||||
| Microbiol responses were presumed from clinical responses for all subjects | ||||||||
| Carmeli 2016; adults (21) | Mostly carbapenems | 3 | NS | 333 | cUTI, cIAI | Solid organ transplant | Mortality: 4/164 (2.4) vs 5/168 (3.0) | |
| Clinical cure TOC: 140/154 (91; 85.6–94.7) vs 135/148 (91; 85.9–95.0) | ||||||||
| Microbiol response TOC: 118/144 (82; 75.1–87.6) vs 88/137 (64; 56.0–71.9) | ||||||||
| Torres 2016; adults (87) | Mero | 3 | NI | 879 | NP | Lung or heart transplant; HIV (CD4 <200/mm3); chemotherapy; immunosuppressive therapy; neutropenia <500/mm3 | Mortality: 42/436 (9.6) vs 36/434 (8.3) | |
| Clinical cure TOC: 245/356 (68·8) vs 270/370 (73·0) | −4.2 (−10.76 to 2.46) | |||||||
| Microbiol response TOC: 95/171 (55.6) vs 118/184 (64.1) | −8.6 (−18.65 to 1.64) | |||||||
| Lucasti 2013; adults (314) | Mero | 2 | NS | 204 | cIAI | HIV (CD4 <200/mm3); chemotherapy; immunosuppressive therapy; neutropenia <1,500/mm3 | Mortality: 3/101 (3.0) vs 2/102 (2.0) | |
| Clinical cure TOC: 80/87 (92.0) vs 85/90 (94.4) | −2.5 (−19.5 to 10.1) | |||||||
| Microbiol response TOC: 62/68 (91.2) vs 71/76 (93.4) | ||||||||
| Mazuski 2016; adults (79) | Mero | 3 | NI | 1,066 | cIAI | HIV (CD4 <200/mm3); chemotherapy; immunosuppressive therapy; neutropenia <1,000/mm3 | Mortality: 13/529 (2.5) vs 8/529 (1.5) | |
| Clinical cure TOC: 337/413 (81.6) vs 349/410 (85.1) | −3.5 (−8.64 to 1.58) | |||||||
| Microbiol response presumed based on clinical outcome | ||||||||
| Wagenlehner 2016; adults (86) | Dori | 3 | NI | 1,033 | cUTI | Renal transplant; HIV (CD4 <200/mm3); chemotherapy; immunosuppressive therapy; neutropenia <500/mm3 | Mortality: 0/511 vs 0/509 | |
| Clinical cure TOC: 355/393 (90.3) vs 377/417 (90.4) | −0.1 (−4.23 to 4.03) | |||||||
| Microbiol response: 304/393 (77.4) vs 296/417 (71.0) | 6.4 (0.33 to 12.36) | |||||||
| Bradley 2019; children (95) | Mero | 2 | Noninferential | 83 | cIAI | No | Mortality: 0/61 vs 0/22 | |
| Clinical cure TOC: 56/61 (91.8) vs 21/22 (95.5) | ||||||||
| Microbiol response TOC: 45/50 (90.0) vs 18/19 (94.7) | ||||||||
| Bradley 2019; children (96) | Cefepime | 2 | Noninferential | 97 | cUTI | Renal transplant | Mortality: 0/68 vs 0/29 | |
| Clinical cure TOC: 48/54 (88.9) vs 19/23 (82.6) | ||||||||
| Microbiol response TOC: 43/54 (79.6) vs 14/23 (60.9) | ||||||||
a
ID, identifier.
b
Imi, imipenem; Mero, meropenem; Dori, doripenem.
c
NI, noninferiority; NS, not specified.
d
cUTI, complicated urinary tract infection; cIAI, complicated intra-abdominal infection; NP, nosocomial pneumonia.
e
CI, confidence interval; TOC, test of cure; microbiol, microbiological.