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  • Paul, MicalRambam Hlth Care Campus, Inst Infect Dis, IL-3109601 Haifa, Israel;Technion Israel Inst Technol, Fac Med, Haifa, Israel (författare)

Colistin alone versus colistin plus meropenem for treatment of severe infections caused by carbapenem-resistant Gram-negative bacteria : an open-label, randomised controlled trial

  • Artikel/kapitelEngelska2018

Förlag, utgivningsår, omfång ...

  • ELSEVIER SCI LTD,2018
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-353117
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-353117URI
  • https://doi.org/10.1016/S1473-3099(18)30099-9DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Background: Colistin-carbapenem combinations are synergistic in vitro against carbapenem-resistant Gram-negative bacteria. We aimed to test whether combination therapy improves clinical outcomes for adults with infections caused by carbapenem-resistant or carbapenemase-producing Gram-negative bacteria.Methods: A randomised controlled superiority trial was done in six hospitals in Israel, Greece, and Italy. We included adults with bacteraemia, ventilator-associated pneumonia, hospital-acquired pneumonia, or urosepsis caused by carbapenem-non-susceptible Gram-negative bacteria. Patients were randomly assigned (1:1) centrally, by computer-generated permuted blocks stratified by centre, to intravenous colistin (9-million unit loading dose, followed by 45 million units twice per day) or colistin with meropenem (2-g prolonged infusion three times per day). The trial was open-label, with blinded outcome assessment. Treatment success was defined as survival, haemodynamic stability, improved or stable Sequential Organ Failure Assessment score, stable or improved ratio of partial pressure of arterial oxygen to fraction of expired oxygen for patients with pneumonia, and microbiological cure for patients with bacteraemia. The primary outcome was clinical failure, defined as not meeting all success criteria by intention-to-treat analysis, at 14 days after randomisation. This trial is registered at ClinicalTrials.gov, number NCT01732250, and is closed to accrual.Findings: Between Oct 1, 2013, and Dec 31, 2016, we randomly assigned 406 patients to the two treatment groups. Most patients had pneumonia or bacteraemia (355/406, 87%), and most infections were caused by Acinetobacter baumannii (312/406, 77%). No significant difference between colistin monotherapy (156/198, 79%) and combination therapy (152/208, 73%) was observed for clinical failure at 14 days after randomisation (risk difference -5.7%, 95% CI -13.9 to 2.4; risk ratio [RR] 0.93, 95% CI 0.83-1.03). Results were similar among patients with A baumannii infections (RR 0.97, 95% CI 0.87-1.09). Combination therapy increased the incidence of diarrhoea (56 [27%] vs 32 [16%] patients) and decreased the incidence of mild renal failure (37 [30%] of 124 vs 25 [20%] of 125 patients at risk of or with kidney injury).Interpretation: Combination therapy was not superior to monotherapy. The addition of meropenem to colistin did not improve clinical failure in severe A baumannii infections. The trial was unpowered to specifically address other bacteria.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Daikos, George L.Laikon Gen Hosp, Dept Med 1, Athens, Greece;Univ Athens, Athens, Greece (författare)
  • Durante-Mangoni, EmanueleUniv Campania L Vanvitelli, Internal Med, Naples, Italy;AORN Colli Monaldi Hosp, Naples, Italy (författare)
  • Yahav, DafnaBeilinson Med Ctr, Infect Dis Unit, Petah Tiqwa, Israel;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel (författare)
  • Carmeli, YehudaTel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel;Tel Aviv Sourasky Med Ctr, Div Epidemiol & Prevent Med, Tel Aviv, Israel (författare)
  • Benattar, Yael DishonRambam Hlth Care Campus, Inst Infect Dis, IL-3109601 Haifa, Israel;Univ Haifa, Cheryl Spencer Dept Nursing, Haifa, Israel (författare)
  • Skiada, AnnaLaikon Gen Hosp, Dept Med 1, Athens, Greece;Univ Athens, Athens, Greece (författare)
  • Andini, RobertoUniv Campania L Vanvitelli, Internal Med, Naples, Italy;AORN Colli Monaldi Hosp, Naples, Italy (författare)
  • Eliakim-Raz, NoaBeilinson Med Ctr, Infect Dis Unit, Petah Tiqwa, Israel;Beilinson Med Ctr, Dept Med E, Rabin Med Ctr, Petah Tiqwa, Israel;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel (författare)
  • Nutman, AmirTel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel;Tel Aviv Sourasky Med Ctr, Div Epidemiol & Prevent Med, Tel Aviv, Israel (författare)
  • Zusman, OrenBeilinson Med Ctr, Dept Med E, Rabin Med Ctr, Petah Tiqwa, Israel;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel (författare)
  • Antoniadou, AnastasiaUniv Athens, Athens, Greece;Attikon Univ, Gen Hosp, Dept Med 4, Athens, Greece (författare)
  • Pafundi, Pia ClaraUniv Campania L Vanvitelli, Internal Med, Naples, Italy;AORN Colli Monaldi Hosp, Naples, Italy (författare)
  • Adler, AmosTel Aviv Sourasky Med Ctr, Microbiol Lab, Tel Aviv, Israel (författare)
  • Dickstein, YaakovRambam Hlth Care Campus, Inst Infect Dis, IL-3109601 Haifa, Israel (författare)
  • Pavleas, IoannisLaikon Gen Hosp, Intens Care Unit, Athens, Greece (författare)
  • Zampino, RosaUniv Campania L Vanvitelli, Internal Med, Naples, Italy;AORN Colli Monaldi Hosp, Naples, Italy (författare)
  • Daitch, VeredBeilinson Med Ctr, Dept Med E, Rabin Med Ctr, Petah Tiqwa, Israel;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel (författare)
  • Bitterman, RoniRambam Hlth Care Campus, Inst Infect Dis, IL-3109601 Haifa, Israel (författare)
  • Zayyad, HibaRambam Hlth Care Campus, Inst Infect Dis, IL-3109601 Haifa, Israel (författare)
  • Koppel, FidiRambam Hlth Care Campus, Inst Infect Dis, IL-3109601 Haifa, Israel (författare)
  • Levi, InbarTel Aviv Sourasky Med Ctr, Div Epidemiol & Prevent Med, Tel Aviv, Israel (författare)
  • Babich, TanyaBeilinson Med Ctr, Dept Med E, Rabin Med Ctr, Petah Tiqwa, Israel;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel (författare)
  • Friberg, Lena EUppsala universitet,Institutionen för farmaceutisk biovetenskap(Swepub:uu)lenasimo (författare)
  • Mouton, Johan W.Erasmus MC, Dept Med Microbiol & Infect Dis, Rotterdam, Netherlands (författare)
  • Theuretzbacher, UrsulaCtr Antiinfect Agents, Vienna, Austria (författare)
  • Leibovici, LeonardBeilinson Med Ctr, Dept Med E, Rabin Med Ctr, Petah Tiqwa, Israel;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel (författare)
  • Rambam Hlth Care Campus, Inst Infect Dis, IL-3109601 Haifa, Israel;Technion Israel Inst Technol, Fac Med, Haifa, IsraelLaikon Gen Hosp, Dept Med 1, Athens, Greece;Univ Athens, Athens, Greece (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet - Infectious diseases: ELSEVIER SCI LTD18:4, s. 391-4001473-30991474-4457

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