Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Clinical and microbiological outcomes, by causative pathogen, in the ASPECT-NP randomized, controlled, Phase 3 trial comparing ceftolozane/tazobactam and meropenem for treatment of hospital-acquired/ventilator-associated bacterial pneumonia

I. Martin-Loeches, JF. Timsit, MH. Kollef, RG. Wunderink, N. Shime, M. Nováček, Ü. Kivistik, Á. Réa-Neto, CJ. Bruno, JA. Huntington, G. Lin, EH. Jensen, M. Motyl, B. Yu, D. Gates, JR. Butterton, EG. Rhee

. 2022 ; 77 (4) : 1166-1177. [pub] 20220331

Jazyk angličtina Země Velká Británie

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc22019087

Grantová podpora
U19 AI135964 NIAID NIH HHS - United States

OBJECTIVES: In the ASPECT-NP trial, ceftolozane/tazobactam was non-inferior to meropenem for treating nosocomial pneumonia; efficacy outcomes by causative pathogen were to be evaluated. METHODS: Mechanically ventilated participants with hospital-acquired/ventilator-associated bacterial pneumonia were randomized to 3 g ceftolozane/tazobactam (2 g ceftolozane/1 g tazobactam) q8h or 1 g meropenem q8h. Lower respiratory tract (LRT) cultures were obtained ≤36 h before first dose; pathogen identification and susceptibility were confirmed at a central laboratory. Prospective secondary per-pathogen endpoints included 28 day all-cause mortality (ACM), and clinical and microbiological response at test of cure (7-14 days after the end of therapy) in the microbiological ITT (mITT) population. RESULTS: The mITT population comprised 511 participants (264 ceftolozane/tazobactam, 247 meropenem). Baseline LRT pathogens included Klebsiella pneumoniae (34.6%), Pseudomonas aeruginosa (25.0%) and Escherichia coli (18.2%). Among baseline Enterobacterales isolates, 171/456 (37.5%) were ESBL positive. For Gram-negative baseline LRT pathogens, susceptibility rates were 87.0% for ceftolozane/tazobactam and 93.3% for meropenem. For Gram-negative pathogens, 28 day ACM [52/259 (20.1%) and 62/240 (25.8%)], clinical cure rates [157/259 (60.6%) and 137/240 (57.1%)] and microbiological eradication rates [189/259 (73.0%) and 163/240 (67.9%)] were comparable with ceftolozane/tazobactam and meropenem, respectively. Per-pathogen microbiological eradication for Enterobacterales [145/195 (74.4%) and 129/185 (69.7%); 95% CI: -4.37 to 13.58], ESBL-producing Enterobacterales [56/84 (66.7%) and 52/73 (71.2%); 95% CI: -18.56 to 9.93] and P. aeruginosa [47/63 (74.6%) and 41/65 (63.1%); 95% CI: -4.51 to 19.38], respectively, were also comparable. CONCLUSIONS: In mechanically ventilated participants with nosocomial pneumonia owing to Gram-negative pathogens, ceftolozane/tazobactam was comparable with meropenem for per-pathogen 28 day ACM and clinical and microbiological response.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22019087
003      
CZ-PrNML
005      
20220804135342.0
007      
ta
008      
220720s2022 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1093/jac/dkab494 $2 doi
035    __
$a (PubMed)35022730
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Martin-Loeches, Ignacio $u St James's Hospital, Trinity College Dublin, James Street, Dublin 8, Ireland $u Universitat de Barcelona, IDIBAPS, CIBERes, Barcelona, Spain
245    10
$a Clinical and microbiological outcomes, by causative pathogen, in the ASPECT-NP randomized, controlled, Phase 3 trial comparing ceftolozane/tazobactam and meropenem for treatment of hospital-acquired/ventilator-associated bacterial pneumonia / $c I. Martin-Loeches, JF. Timsit, MH. Kollef, RG. Wunderink, N. Shime, M. Nováček, Ü. Kivistik, Á. Réa-Neto, CJ. Bruno, JA. Huntington, G. Lin, EH. Jensen, M. Motyl, B. Yu, D. Gates, JR. Butterton, EG. Rhee
520    9_
$a OBJECTIVES: In the ASPECT-NP trial, ceftolozane/tazobactam was non-inferior to meropenem for treating nosocomial pneumonia; efficacy outcomes by causative pathogen were to be evaluated. METHODS: Mechanically ventilated participants with hospital-acquired/ventilator-associated bacterial pneumonia were randomized to 3 g ceftolozane/tazobactam (2 g ceftolozane/1 g tazobactam) q8h or 1 g meropenem q8h. Lower respiratory tract (LRT) cultures were obtained ≤36 h before first dose; pathogen identification and susceptibility were confirmed at a central laboratory. Prospective secondary per-pathogen endpoints included 28 day all-cause mortality (ACM), and clinical and microbiological response at test of cure (7-14 days after the end of therapy) in the microbiological ITT (mITT) population. RESULTS: The mITT population comprised 511 participants (264 ceftolozane/tazobactam, 247 meropenem). Baseline LRT pathogens included Klebsiella pneumoniae (34.6%), Pseudomonas aeruginosa (25.0%) and Escherichia coli (18.2%). Among baseline Enterobacterales isolates, 171/456 (37.5%) were ESBL positive. For Gram-negative baseline LRT pathogens, susceptibility rates were 87.0% for ceftolozane/tazobactam and 93.3% for meropenem. For Gram-negative pathogens, 28 day ACM [52/259 (20.1%) and 62/240 (25.8%)], clinical cure rates [157/259 (60.6%) and 137/240 (57.1%)] and microbiological eradication rates [189/259 (73.0%) and 163/240 (67.9%)] were comparable with ceftolozane/tazobactam and meropenem, respectively. Per-pathogen microbiological eradication for Enterobacterales [145/195 (74.4%) and 129/185 (69.7%); 95% CI: -4.37 to 13.58], ESBL-producing Enterobacterales [56/84 (66.7%) and 52/73 (71.2%); 95% CI: -18.56 to 9.93] and P. aeruginosa [47/63 (74.6%) and 41/65 (63.1%); 95% CI: -4.51 to 19.38], respectively, were also comparable. CONCLUSIONS: In mechanically ventilated participants with nosocomial pneumonia owing to Gram-negative pathogens, ceftolozane/tazobactam was comparable with meropenem for per-pathogen 28 day ACM and clinical and microbiological response.
650    12
$a antibakteriální látky $x terapeutické užití $7 D000900
650    _2
$a cefalosporiny $x terapeutické užití $7 D002511
650    _2
$a nemocnice $7 D006761
650    _2
$a lidé $7 D006801
650    _2
$a meropenem $x terapeutické užití $7 D000077731
650    _2
$a mikrobiální testy citlivosti $7 D008826
650    12
$a bakteriální pneumonie $x farmakoterapie $7 D018410
650    _2
$a prospektivní studie $7 D011446
650    _2
$a Pseudomonas aeruginosa $7 D011550
650    _2
$a tazobaktam $x terapeutické užití $7 D000078142
650    _2
$a mechanické ventilátory $7 D012122
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Timsit, Jean-François $u UMR 1137, IAME, Université Paris Diderot, F75018, Paris, France
700    1_
$a Kollef, Marin H $u Washington University School of Medicine, 4523 Clayton Ave, Campus Box 8052, St. Louis, MO 63110, USA
700    1_
$a Wunderink, Richard G $u Northwestern University Feinberg School of Medicine, 303 East Superior St, Simpson Querrey 5th Floor, Suite 5-301, Chicago, IL 60611, USA
700    1_
$a Shime, Nobuaki $u Hiroshima University, 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan
700    1_
$a Nováček, Martin $u General Hospital of Kolin, Zizkova 146, Kolin 3, 280 00, Czech Republic
700    1_
$a Kivistik, Ülo $u North Estonia Medical Centre Foundation, Sütiste tee 19, Tallinn, Harjumaa 13419, Estonia
700    1_
$a Réa-Neto, Álvaro $u Universidade Federal do Paraná, Rua XV de Novembro, 1299 - Centro, Curitiba - PR, 80060-000, Brazil
700    1_
$a Bruno, Christopher J $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Huntington, Jennifer A $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Lin, Gina $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Jensen, Erin H $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Motyl, Mary $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Yu, Brian $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Gates, Davis $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Butterton, Joan R $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
700    1_
$a Rhee, Elizabeth G $u Merck & Co., Inc., 2000 Galloping Hill Rd, Kenilworth, NJ 07033, USA
773    0_
$w MED00002514 $t The Journal of antimicrobial chemotherapy $x 1460-2091 $g Roč. 77, č. 4 (2022), s. 1166-1177
856    41
$u https://pubmed.ncbi.nlm.nih.gov/35022730 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220720 $b ABA008
991    __
$a 20220804135335 $b ABA008
999    __
$a ok $b bmc $g 1822623 $s 1170330
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2022 $b 77 $c 4 $d 1166-1177 $e 20220331 $i 1460-2091 $m Journal of antimicrobial chemotherapy $n J Antimicrob Chemother $x MED00002514
GRA    __
$a U19 AI135964 $p NIAID NIH HHS $2 United States
LZP    __
$a Pubmed-20220720

Najít záznam

Citační ukazatele

Možnosti archivace