Multicentre open-label randomised controlled trial to compare colistin alone with colistin plus meropenem for the treatment of severe infections caused by carbapenem-resistant Gram-negative infections (AIDA): a study protocol

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Multicentre open-label randomised controlled trial to compare colistin alone with colistin plus meropenem for the treatment of severe infections caused by carbapenem-resistant Gram-negative infections (AIDA) : a study protocol

Dickstein, Yaakov (författare): Rambam Hlth Care Campus, Div Infect Dis, Haifa, Israel.

Leibovici, Leonard (författare): Beilinson Med Ctr, Rabin Med Ctr, Dept Med E, Petah Tiqwa, Israel.;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel.

Yahav, Dafna (författare): Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel.;Beilinson Med Ctr, Rabin Med Ctr, Infect Dis Unit, Petah Tiqwa, Israel.

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Eliakim-Raz, Noa (författare): Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel.;Beilinson Med Ctr, Rabin Med Ctr, Infect Dis Unit, Petah Tiqwa, Israel.

Daikos, George L. (författare): Univ Athens, Dept Med 1, Athens, Greece.

Skiada, Anna (författare): Univ Athens, Dept Med 1, Athens, Greece.

Antoniadou, Anastasia (författare): Univ Athens, Dept Med 4, Athens, Greece.

Carmeli, Yehuda (författare): Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Div Epidemiol & Prevent Med, IL-69978 Tel Aviv, Israel.

Nutman, Amir (författare): Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel.;Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Div Epidemiol & Prevent Med, IL-69978 Tel Aviv, Israel.

Levi, Inbar (författare): Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Div Epidemiol & Prevent Med, IL-69978 Tel Aviv, Israel.

Adler, Amos (författare): Tel Aviv Univ, Tel Aviv Sourasky Med Ctr, Microbiol Lab, IL-69978 Tel Aviv, Israel.

Durante-Mangoni, Emanuele (författare): Univ Naples 2, Monaldi Hosp AORN Colli, Internal Med, Naples, Italy.

Andini, Roberto (författare): Univ Naples 2, Monaldi Hosp AORN Colli, Internal Med, Naples, Italy.

Cavezza, Giusi (författare): Univ Naples 2, Monaldi Hosp AORN Colli, Internal Med, Naples, Italy.

Mouton, Johan W. (författare): Erasmus MC, Dept Med Microbiol & Infect Dis, Rotterdam, Netherlands.;Radboudumc, Dept Med Microbiol, Nijmegen, Netherlands.

Wijma, Rixt A. (författare): Erasmus MC, Dept Med Microbiol & Infect Dis, Rotterdam, Netherlands.

Theuretzbacher, Ursula (författare): Ctr Antiinfect Agents, Vienna, Austria.

Friberg, Lena E. (författare): Uppsala universitet,Institutionen för farmaceutisk biovetenskap

Kristoffersson, Anders N. (författare): Uppsala universitet,Institutionen för farmaceutisk biovetenskap

Zusman, Oren (författare): Beilinson Med Ctr, Rabin Med Ctr, Dept Med E, Petah Tiqwa, Israel.;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel.

Koppel, Fidi (författare): Rambam Hlth Care Campus, Div Infect Dis, Haifa, Israel.

Benattar, Yael Dishon (författare): Rambam Hlth Care Campus, Div Infect Dis, Haifa, Israel.

Altunin, Sergey (författare): Technion Israel Inst Technol, Fac Med, Haifa, Israel.

Paul, Mical (författare): Rambam Hlth Care Campus, Div Infect Dis, Haifa, Israel.;Technion Israel Inst Technol, Fac Med, Haifa, Israel.

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Rambam Hlth Care Campus, Div Infect Dis, Haifa, Israel Beilinson Med Ctr, Rabin Med Ctr, Dept Med E, Petah Tiqwa, Israel.;Tel Aviv Univ, Sackler Fac Med, Ramat Aviv, Israel. (creator_code:org_t)

2016-04-20
2016
Engelska.
Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 6:4

Relaterad länk:: https://doi.org/10.1...; visa fler...; https://uu.diva-port... (primary) (Raw object); https://bmjopen.bmj....; https://urn.kb.se/re...; https://doi.org/10.1...; visa färre...

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Introduction: The emergence of antibiotic-resistant bacteria has driven renewed interest in older antibacterials, including colistin. Previous studies have shown that colistin is less effective and more toxic than modern antibiotics. In vitro synergy studies and clinical observational studies suggest a benefit of combining colistin with a carbapenem. A randomised controlled study is necessary for clarification. Methods and analysis: This is a multicentre, investigator-initiated, open-label, randomised controlled superiority 1:1 study comparing colistin monotherapy with colistin-meropenem combination therapy for infections caused by carbapenem-resistant Gram-negative bacteria. The study is being conducted in 6 centres in 3 countries (Italy, Greece and Israel). We include patients with hospital-associated and ventilator-associated pneumonia, bloodstream infections and urosepsis. The primary outcome is treatment success at day 14, defined as survival, haemodynamic stability, stable or improved respiratory status for patients with pneumonia, microbiological cure for patients with bacteraemia and stability or improvement of the Sequential Organ Failure Assessment (SOFA) score. Secondary outcomes include 14-day and 28-day mortality as well as other clinical end points and safety outcomes. A sample size of 360 patients was calculated on the basis of an absolute improvement in clinical success of 15% with combination therapy. Outcomes will be assessed by intention to treat. Serum colistin samples are obtained from all patients to obtain population pharmacokinetic models. Microbiological sampling includes weekly surveillance samples with analysis of resistance mechanisms and synergy. An observational trial is evaluating patients who met eligibility requirements but were not randomised in order to assess generalisability of findings. Ethics and dissemination: The study was approved by ethics committees at each centre and informed consent will be obtained for all patients. The trial is being performed under the auspices of an independent data and safety monitoring committee and is included in a broad dissemination strategy regarding revival of old antibiotics.

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Multicentre open-label randomised controlled trial to compare colistin alone with colistin plus meropenem for the treatment of severe infections caused by carbapenem-resistant Gram-negative infections (AIDA) : a study protocol

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