An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019)
The aim of the study was to evaluate the effectiveness of cefepime/sulbactam in patients with intra-abdominal infection, nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP) in actual clinical practice. Material and methods. The study was conducted in 14 Russian Clinics from October 20...
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2021-02-01
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| Online Access: | https://www.antibiotics-chemotherapy.ru/jour/article/view/776 |
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| author | S. V. Yakovlev M. P. Suvorova A. O. Bykov S. V. Zhuravel K. A. Popugaev L. Yu. Kulagina I. N. Ochakovskaya M. G. Fedorova O. V. Pribytkova A. A. Zateyshchikova O. G. Malkova T. N. Malorodova E. S. Nekaeva N. G. Ogonkin Yu. A. Strezh I. N. Sychev O. I. Tazieva S. G. Fominykh |
| author_facet | S. V. Yakovlev M. P. Suvorova A. O. Bykov S. V. Zhuravel K. A. Popugaev L. Yu. Kulagina I. N. Ochakovskaya M. G. Fedorova O. V. Pribytkova A. A. Zateyshchikova O. G. Malkova T. N. Malorodova E. S. Nekaeva N. G. Ogonkin Yu. A. Strezh I. N. Sychev O. I. Tazieva S. G. Fominykh |
| author_sort | S. V. Yakovlev |
| collection | DOAJ |
| description | The aim of the study was to evaluate the effectiveness of cefepime/sulbactam in patients with intra-abdominal infection, nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP) in actual clinical practice. Material and methods. The study was conducted in 14 Russian Clinics from October 2019 to March 2020. Study design: an open-label, prospective, non-comparative, multicenter, observational study. The study included patients who met the inclusion/exclusion criteria and signed a written informed consent. The studied antibiotic: cefepime/sulbactam (Maxictam®-AF). The primary parameter for effectiveness evaluation was the clinical effect after the conclusion of cefepime/sulbactam therapy — recovery/improvement or no effect. Results. The study included 140 patients (average age — 60.8 years) who received at least one dose of cefepime/sulbactam; 37 of them had intraabdominal infection, 72 — NP, and 31 — VAP. Most of the included patients were in the ICU department (82.1%) and their condition was severe: the average APACHE II score was 15.5 points, SOFA — 5.4 points, the Mannheim peritonitis index value in patients with intra-abdominal infection was from 14 to 35 points, with an average of 24.3 points. The majority of patients treated with cefepime/sulbactam (68.6%) had one or more risk factors for multi-resistant pathogens upon hospital or ICU admission. Cefepime/sulbactam was prescribed as the 1st or 2nd line of empirical therapy at a daily dose of 4 g (in 68.3%), 6 g (2.9%) or 8 g (28.8%); most patients were prescribed cefepime/sulbactam in monotherapy (72.3%). The average duration of therapy with cefepime/sulbactam was 9.6±3.5 days. The final assessment of treatment effectiveness was carried out in 132 patients: recovery or improvement was noted in 80.6% of patients with intra-abdominal infection, the effectiveness in NP and VAP was slightly higher — 95.6 and 89.3%. The effect was absent in 5.3% of patients, relapse or superinfection was noted in 3.0 and 1.5%. The majority of patients (81.3%) treated with cefepime/sulbactam were discharged from the hospital. No serious side effects were observed. In patients with a positive effect, age and values of APACHE II were significantly lower (59.58 years and 14.79 points) compared to those with no effect (67.95 years and 18.39 points). A multivariate analysis found that the probability of recovery of patients treated with cefepime/sulbactam did not depend on the diagnosis of infection, ICU admission, the presence of sepsis or septic shock. Conclusion. The multicenter study has established a high clinical efficacy of cefepime/sulbactam in real clinical practice in the treatment of patients with severe intraabdominal infection, nosocomial pneumonia or ventilator-associated pneumonia. |
| format | Article |
| id | doaj-art-a99b4fea45ec4f7ebd0101f21d7b02c1 |
| institution | Matheson Library |
| issn | 0235-2990 |
| language | Russian |
| publishDate | 2021-02-01 |
| publisher | LLC "Publishing House OKI" |
| record_format | Article |
| series | Антибиотики и Химиотерапия |
| spelling | doaj-art-a99b4fea45ec4f7ebd0101f21d7b02c12025-08-03T13:04:48ZrusLLC "Publishing House OKI"Антибиотики и Химиотерапия0235-29902021-02-016511-12495810.37489/0235-2990-2020-65-11-12-49-58759An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019)S. V. Yakovlev0M. P. Suvorova1A. O. Bykov2S. V. Zhuravel3K. A. Popugaev4L. Yu. Kulagina5I. N. Ochakovskaya6M. G. Fedorova7O. V. Pribytkova8A. A. Zateyshchikova9O. G. Malkova10T. N. Malorodova11E. S. Nekaeva12N. G. Ogonkin13Yu. A. Strezh14I. N. Sychev15O. I. Tazieva16S. G. Fominykh17I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian FederationI. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian FederationPirogov Russian National Research Medical UniversitySklifosovsky Research Institute for Emergency MedicineSklifosovsky Research Institute for Emergency MedicineRepublican Clinical Hospital of the Ministry of Health of Republic of TatarstanRegional Clinical Hospital No. 2Irkutsk City Clinical Hospital No. 1Chelyabinsk Regional Clinical Hospital No. 3City Clinical Hospital No. 51Sverdlovsk Regional Clinical Hospital No. 1City Hospital No. 2Privolzhsky Research Medical UniversityPacific State Medical UniversityTomsk Regional Clinical HospitalS. S.Yudin City Clinical HospitalS. N. Greenberg City Clinical HospitalOmsk State Medical UniversityThe aim of the study was to evaluate the effectiveness of cefepime/sulbactam in patients with intra-abdominal infection, nosocomial pneumonia (NP) or ventilator-associated pneumonia (VAP) in actual clinical practice. Material and methods. The study was conducted in 14 Russian Clinics from October 2019 to March 2020. Study design: an open-label, prospective, non-comparative, multicenter, observational study. The study included patients who met the inclusion/exclusion criteria and signed a written informed consent. The studied antibiotic: cefepime/sulbactam (Maxictam®-AF). The primary parameter for effectiveness evaluation was the clinical effect after the conclusion of cefepime/sulbactam therapy — recovery/improvement or no effect. Results. The study included 140 patients (average age — 60.8 years) who received at least one dose of cefepime/sulbactam; 37 of them had intraabdominal infection, 72 — NP, and 31 — VAP. Most of the included patients were in the ICU department (82.1%) and their condition was severe: the average APACHE II score was 15.5 points, SOFA — 5.4 points, the Mannheim peritonitis index value in patients with intra-abdominal infection was from 14 to 35 points, with an average of 24.3 points. The majority of patients treated with cefepime/sulbactam (68.6%) had one or more risk factors for multi-resistant pathogens upon hospital or ICU admission. Cefepime/sulbactam was prescribed as the 1st or 2nd line of empirical therapy at a daily dose of 4 g (in 68.3%), 6 g (2.9%) or 8 g (28.8%); most patients were prescribed cefepime/sulbactam in monotherapy (72.3%). The average duration of therapy with cefepime/sulbactam was 9.6±3.5 days. The final assessment of treatment effectiveness was carried out in 132 patients: recovery or improvement was noted in 80.6% of patients with intra-abdominal infection, the effectiveness in NP and VAP was slightly higher — 95.6 and 89.3%. The effect was absent in 5.3% of patients, relapse or superinfection was noted in 3.0 and 1.5%. The majority of patients (81.3%) treated with cefepime/sulbactam were discharged from the hospital. No serious side effects were observed. In patients with a positive effect, age and values of APACHE II were significantly lower (59.58 years and 14.79 points) compared to those with no effect (67.95 years and 18.39 points). A multivariate analysis found that the probability of recovery of patients treated with cefepime/sulbactam did not depend on the diagnosis of infection, ICU admission, the presence of sepsis or septic shock. Conclusion. The multicenter study has established a high clinical efficacy of cefepime/sulbactam in real clinical practice in the treatment of patients with severe intraabdominal infection, nosocomial pneumonia or ventilator-associated pneumonia.https://www.antibiotics-chemotherapy.ru/jour/article/view/776cefepime/sulbactamprospective clinical trialmulticenter studynosocomial pneumoniaventilator-associated pneumoniaintra-abdominal infectioncarbapenem-sparing therapycarbapenem-replacement therapy |
| spellingShingle | S. V. Yakovlev M. P. Suvorova A. O. Bykov S. V. Zhuravel K. A. Popugaev L. Yu. Kulagina I. N. Ochakovskaya M. G. Fedorova O. V. Pribytkova A. A. Zateyshchikova O. G. Malkova T. N. Malorodova E. S. Nekaeva N. G. Ogonkin Yu. A. Strezh I. N. Sychev O. I. Tazieva S. G. Fominykh An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019) Антибиотики и Химиотерапия cefepime/sulbactam prospective clinical trial multicenter study nosocomial pneumonia ventilator-associated pneumonia intra-abdominal infection carbapenem-sparing therapy carbapenem-replacement therapy |
| title | An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019) |
| title_full | An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019) |
| title_fullStr | An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019) |
| title_full_unstemmed | An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019) |
| title_short | An Open-Label, Multicenter, Observational Study of The Effectiveness of The Cefepime/Sulbactam Antibiotic (Maxictam<sup>®</sup>-AF) In Patients With Intra Abdominal Infection, Nosocomial Pneumonia or Ventilator-Associated Pneumonia (Study MAXI-2019) |
| title_sort | open label multicenter observational study of the effectiveness of the cefepime sulbactam antibiotic maxictam sup r sup af in patients with intra abdominal infection nosocomial pneumonia or ventilator associated pneumonia study maxi 2019 |
| topic | cefepime/sulbactam prospective clinical trial multicenter study nosocomial pneumonia ventilator-associated pneumonia intra-abdominal infection carbapenem-sparing therapy carbapenem-replacement therapy |
| url | https://www.antibiotics-chemotherapy.ru/jour/article/view/776 |
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