RESTORE-IMI 1: a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infections
The β-lactamase inhibitor relebactam can restore imipenem activity against imipenem-nonsusceptible gram-negative pathogens. We evaluated imipenem/relebactam for treating imipenem-nonsusceptible infections.Randomized, controlled, double-blind, phase 3 trial. Hospitalized patients with hospital-acquir...
Gespeichert in:
| Hauptverfasser: | , , , , , , , , , , , , , , , , , |
|---|---|
| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2020
|
| In: |
Clinical infectious diseases
Year: 2019, Jahrgang: 70, Heft: 9, Pages: 1799-1808 |
| ISSN: | 1537-6591 |
| DOI: | 10.1093/cid/ciz530 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/cid/ciz530 Verlag, lizenzpflichtig, Volltext: https://academic.oup.com/cid/article/70/9/1799/5546004 
|
| Verfasserangaben: | Johann Motsch, Cláudia Murta de Oliveira, Viktor Stus, Iftihar Köksal, Olexiy Lyulko, Helen W. Boucher, Keith S. Kaye, Thomas M. File Jr, Michelle L. Brown, Ireen Khan, Jiejun Du, Hee-Koung Joeng, Robert W. Tipping, Angela Aggrey, Katherine Young, Nicholas A. Kartsonis, Joan R. Butterton, and Amanda Paschke |
MARC
| LEADER | 00000caa a2200000 c 4500 | ||
|---|---|---|---|
| 001 | 1752935276 | ||
| 003 | DE-627 | ||
| 005 | 20230427070842.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 210331r20202019xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/cid/ciz530 |2 doi | |
| 035 | |a (DE-627)1752935276 | ||
| 035 | |a (DE-599)KXP1752935276 | ||
| 035 | |a (OCoLC)1341402008 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 084 | |a 33 |2 sdnb | ||
| 100 | 1 | |a Motsch, Johann |d 1952- |e VerfasserIn |0 (DE-588)1059446626 |0 (DE-627)798468319 |0 (DE-576)415532876 |4 aut | |
| 245 | 1 | 0 | |a RESTORE-IMI 1 |b a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infections |c Johann Motsch, Cláudia Murta de Oliveira, Viktor Stus, Iftihar Köksal, Olexiy Lyulko, Helen W. Boucher, Keith S. Kaye, Thomas M. File Jr, Michelle L. Brown, Ireen Khan, Jiejun Du, Hee-Koung Joeng, Robert W. Tipping, Angela Aggrey, Katherine Young, Nicholas A. Kartsonis, Joan R. Butterton, and Amanda Paschke |
| 246 | 3 | 3 | |a RESTORE-IMI one |
| 264 | 1 | |c 2020 | |
| 300 | |a 10 | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Published online August 10, 2019 | ||
| 500 | |a Gesehen am 31.03.2021 | ||
| 520 | |a The β-lactamase inhibitor relebactam can restore imipenem activity against imipenem-nonsusceptible gram-negative pathogens. We evaluated imipenem/relebactam for treating imipenem-nonsusceptible infections.Randomized, controlled, double-blind, phase 3 trial. Hospitalized patients with hospital-acquired/ventilator-associated pneumonia, complicated intraabdominal infection, or complicated urinary tract infection caused by imipenem-nonsusceptible (but colistin- and imipenem/relebactam-susceptible) pathogens were randomized 2:1 to 5-21 days imipenem/relebactam or colistin+imipenem. Primary endpoint: favorable overall response (defined by relevant endpoints for each infection type) in the modified microbiologic intent-to-treat (mMITT) population (qualifying baseline pathogen and ≥1 dose study treatment). Secondary endpoints: clinical response, all-cause mortality, and treatment-emergent nephrotoxicity. Safety analyses included patients with ≥1 dose study treatment.Thirty-one patients received imipenem/relebactam and 16 colistin+imipenem. Among mITT patients (n = 21 imipenem/relebactam, n = 10 colistin+imipenem), 29% had Acute Physiology and Chronic Health Evaluation II scores >15, 23% had creatinine clearance <60 mL/min, and 35% were aged ≥65 years. Qualifying baseline pathogens: Pseudomonas aeruginosa (77%), Klebsiella spp. (16%), other Enterobacteriaceae (6%). Favorable overall response was observed in 71% imipenem/relebactam and 70% colistin+imipenem patients (90% confidence interval [CI] for difference, -27.5, 21.4), day 28 favorable clinical response in 71% and 40% (90% CI, 1.3, 51.5), and 28-day mortality in 10% and 30% (90% CI, -46.4, 6.7), respectively. Serious adverse events (AEs) occurred in 10% of imipenem/relebactam and 31% of colistin+imipenem patients, drug-related AEs in 16% and 31% (no drug-related deaths), and treatment-emergent nephrotoxicity in 10% and 56% (P = .002), respectively.Imipenem/relebactam is an efficacious and well-tolerated treatment option for carbapenem-nonsusceptible infections.NCT02452047. | ||
| 534 | |c 2019 | ||
| 700 | 1 | |a Murta de Oliveira, Cláudia |e VerfasserIn |4 aut | |
| 700 | 1 | |a Stus, Viktor |e VerfasserIn |4 aut | |
| 700 | 1 | |a Köksal, Iftihar |e VerfasserIn |4 aut | |
| 700 | 1 | |a Lyulko, Olexiy |e VerfasserIn |4 aut | |
| 700 | 1 | |a Boucher, Helen W |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kaye, Keith S |e VerfasserIn |4 aut | |
| 700 | 1 | |a File, Thomas M, Jr |e VerfasserIn |4 aut | |
| 700 | 1 | |a Brown, Michelle L |e VerfasserIn |4 aut | |
| 700 | 1 | |a Khan, Ireen |e VerfasserIn |4 aut | |
| 700 | 1 | |a Du, Jiejun |e VerfasserIn |4 aut | |
| 700 | 1 | |a Joeng, Hee-Koung |e VerfasserIn |4 aut | |
| 700 | 1 | |a Tipping, Robert W |e VerfasserIn |4 aut | |
| 700 | 1 | |a Aggrey, Angela |e VerfasserIn |4 aut | |
| 700 | 1 | |a Young, Katherine |e VerfasserIn |4 aut | |
| 700 | 1 | |a Kartsonis, Nicholas A |e VerfasserIn |4 aut | |
| 700 | 1 | |a Butterton, Joan R |e VerfasserIn |4 aut | |
| 700 | 1 | |a Paschke, Amanda |e VerfasserIn |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical infectious diseases |d Oxford : Oxford Journals, 1992 |g 70(2020), 9 vom: Mai, Seite 1799-1808 |h Online-Ressource |w (DE-627)320418308 |w (DE-600)2002229-3 |w (DE-576)090881834 |x 1537-6591 |7 nnas |a RESTORE-IMI 1 a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infections |
| 773 | 1 | 8 | |g volume:70 |g year:2020 |g number:9 |g month:05 |g pages:1799-1808 |g extent:10 |a RESTORE-IMI 1 a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infections |
| 856 | 4 | 0 | |u https://doi.org/10.1093/cid/ciz530 |x Verlag |x Resolving-System |z lizenzpflichtig |3 Volltext |
| 856 | 4 | 0 | |u https://academic.oup.com/cid/article/70/9/1799/5546004 |x Verlag |z lizenzpflichtig |3 Volltext |
| 951 | |a AR | ||
| 992 | |a 20210331 | ||
| 993 | |a Article | ||
| 994 | |a 2020 | ||
| 998 | |g 1059446626 |a Motsch, Johann |m 1059446626:Motsch, Johann |d 910000 |d 910300 |d 50000 |e 910000PM1059446626 |e 910300PM1059446626 |e 50000PM1059446626 |k 0/910000/ |k 1/910000/910300/ |k 0/50000/ |p 1 |x j | ||
| 999 | |a KXP-PPN1752935276 |e 3899250036 | ||
| BIB | |a Y | ||
| SER | |a journal | ||
| JSO | |a {"type":{"media":"Online-Ressource","bibl":"article-journal"},"id":{"doi":["10.1093/cid/ciz530"],"eki":["1752935276"]},"note":["Published online August 10, 2019","Gesehen am 31.03.2021"],"name":{"displayForm":["Johann Motsch, Cláudia Murta de Oliveira, Viktor Stus, Iftihar Köksal, Olexiy Lyulko, Helen W. Boucher, Keith S. Kaye, Thomas M. File Jr, Michelle L. Brown, Ireen Khan, Jiejun Du, Hee-Koung Joeng, Robert W. Tipping, Angela Aggrey, Katherine Young, Nicholas A. Kartsonis, Joan R. Butterton, and Amanda Paschke"]},"titleAlt":[{"title":"RESTORE-IMI one"}],"person":[{"roleDisplay":"VerfasserIn","family":"Motsch","given":"Johann","role":"aut","display":"Motsch, Johann"},{"roleDisplay":"VerfasserIn","given":"Cláudia","family":"Murta de Oliveira","role":"aut","display":"Murta de Oliveira, Cláudia"},{"roleDisplay":"VerfasserIn","family":"Stus","given":"Viktor","role":"aut","display":"Stus, Viktor"},{"role":"aut","display":"Köksal, Iftihar","roleDisplay":"VerfasserIn","given":"Iftihar","family":"Köksal"},{"family":"Lyulko","given":"Olexiy","roleDisplay":"VerfasserIn","display":"Lyulko, Olexiy","role":"aut"},{"display":"Boucher, Helen W","role":"aut","family":"Boucher","given":"Helen W","roleDisplay":"VerfasserIn"},{"roleDisplay":"VerfasserIn","given":"Keith S","family":"Kaye","role":"aut","display":"Kaye, Keith S"},{"display":"File, Thomas M, Jr","role":"aut","family":"File, Thomas M, Jr","given":"","roleDisplay":"VerfasserIn"},{"family":"Brown","given":"Michelle L","roleDisplay":"VerfasserIn","display":"Brown, Michelle L","role":"aut"},{"role":"aut","display":"Khan, Ireen","roleDisplay":"VerfasserIn","family":"Khan","given":"Ireen"},{"roleDisplay":"VerfasserIn","given":"Jiejun","family":"Du","role":"aut","display":"Du, Jiejun"},{"role":"aut","display":"Joeng, Hee-Koung","roleDisplay":"VerfasserIn","given":"Hee-Koung","family":"Joeng"},{"display":"Tipping, Robert W","role":"aut","given":"Robert W","family":"Tipping","roleDisplay":"VerfasserIn"},{"display":"Aggrey, Angela","role":"aut","given":"Angela","family":"Aggrey","roleDisplay":"VerfasserIn"},{"role":"aut","display":"Young, Katherine","roleDisplay":"VerfasserIn","given":"Katherine","family":"Young"},{"roleDisplay":"VerfasserIn","family":"Kartsonis","given":"Nicholas A","role":"aut","display":"Kartsonis, Nicholas A"},{"given":"Joan R","family":"Butterton","roleDisplay":"VerfasserIn","display":"Butterton, Joan R","role":"aut"},{"role":"aut","display":"Paschke, Amanda","roleDisplay":"VerfasserIn","given":"Amanda","family":"Paschke"}],"physDesc":[{"extent":"10 S."}],"recId":"1752935276","relHost":[{"physDesc":[{"extent":"Online-Ressource"}],"recId":"320418308","origin":[{"publisher":"Oxford Journals ; Univ. of Chicago Press, Journals Division","publisherPlace":"Oxford ; Chicago, Ill.","dateIssuedDisp":"1992-","dateIssuedKey":"1992"}],"language":["eng"],"disp":"RESTORE-IMI 1 a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infectionsClinical infectious diseases","title":[{"subtitle":"electronic edition","title":"Clinical infectious diseases","title_sort":"Clinical infectious diseases"}],"pubHistory":["14.1992 -"],"part":{"volume":"70","year":"2020","text":"70(2020), 9 vom: Mai, Seite 1799-1808","pages":"1799-1808","issue":"9","extent":"10"},"id":{"eki":["320418308"],"issn":["1537-6591"],"zdb":["2002229-3"]},"type":{"bibl":"periodical","media":"Online-Ressource"},"note":["Gesehen am 31.07.2023"]}],"language":["eng"],"origin":[{"dateIssuedKey":"2020","dateIssuedDisp":"2020"}],"title":[{"title":"RESTORE-IMI 1","title_sort":"RESTORE-IMI 1","subtitle":"a multicenter, randomized, double-blind trial comparing efficacy and safety of imipenem/relebactam vs colistin plus imipenem in patients with imipenem-nonsusceptible bacterial infections"}]} | ||
| SRT | |a MOTSCHJOHARESTOREIMI2020 | ||