Efficacy and safety of intravenous sulbactam/ampicillin 3 g 4 times daily in Japanese adults with moderate to severe community-acquired pneumonia: A multicenter, open-label, uncontrolled study

Objectives: A retrospective examination was conducted to identify risk factors for in-hospital mortality of elderly patients (65 years or older) treated with the beta-lactam/beta-lactamase inhibitor combination antibiotic, ampicillin/sulbactam (ABPC/SBT).Methods: Clinical data from 96 patients who were hospitalized with infectious diseases and treated with ABPC/SBT (9 g/day or 12 g/day) were analyzed. Risk factors examined included demographic and clinical laboratory parameters. Parameter values prior to treatment and changes after treatment were compared between survivors and non-survivors.Results: The study patients had an average age of 81.9±8.4 years (±SD) and body mass index (BMI) of 19.9±4.2 kg/m2. They were characterized by anemia (low hemoglobin and hematocrit levels), inflammation (high leukocyte count, neutrophil count, C-reactive protein level, and body temperature), and hepatic and renal dysfunction (high aspartate aminotransferase, alanine aminotransferase and blood urea nitrogen levels). The BMI of non-survivors, 16.2±2.9 kg/m2, was lower than that of survivors, 20.4±4.1 kg/m2. In addition, the hematological parameters deteriorated more remarkably, inflammation markers were not altered (or the decrease was marginal), and hepatic function was not improved, in non-survivors.Conclusions: A lower BMI value is a risk factor for in-hospital mortality of elderly patients treated with ABPC/SBT.

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“…Our data suggested that 12 g/day of ABPC/SBT was as well tolerated as 9 g/day. This result is similar to findings from earlier study 10 .…”

Section: Discussionsupporting

confidence: 93%

“…The approved maximal daily dose of ABPC/SBT is 12 g (3 g every 6hr) in many countries. However, in Japan, it was recently shown that 12 g/day is well tolerated and provides excellent clinical and bacteriological responses 10 ; this dose was approved in 2012.…”

Section: Introductionmentioning

confidence: 99%

Lower Body Mass Index is a Risk Factor for In-Hospital Mortality of Elderly Japanese Patients Treated with Ampicillin/sulbactam

Miura¹,

Kuwahara²,

Tomozawa³

et al. 2016

Int. J. Med. Sci.

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“…At the time of launching our study, the ABPC/SBT dose was determined according to available drug information in Japan describing that no more than 3 g every 12 h should be administered [30]. Although this dose is lower than the most current standard dose of 3 g every 6 h [31], comparable clinical effectiveness was seen between the ABPC/SBT and CTRX groups, suggesting that a dose of 3 g ABPC/SBT every 12 h might be sufficient in CAP treatment. Recently, shortages in antibiotics have been increasingly discussed [32,33].…”

Section: Discussionmentioning

confidence: 99%

“…To evaluate the effects of treatment, clinical findings, chest radiography findings, and laboratory test results were collected before, during, and at end of treatment (EOT; days [7][8][9][10][11][12][13][14]. The late response to treatment was evaluated at end of study (EOS; days [28][29][30][31][32][33][34][35].…”

Section: Clinical and Bacteriological Evaluationsmentioning

confidence: 99%

Comparison of ceftriaxone plus macrolide and ampicillin/sulbactam plus macrolide in treatment for patients with community-acquired pneumonia without risk factors for aspiration: an open-label, quasi-randomized, controlled trial

et al. 2020

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Background: Ceftriaxone (CTRX) and ampicillin/sulbactam (ABPC/SBT) are recommended by various guidelines as the first-line antibiotics for community-acquired pneumonia (CAP). However, which of these antibiotics is more effective for treating non-aspiration CAP remains unclear. Methods: This study was a prospective, single-center, open-label, quasi-randomized controlled trial. Patients with adult CAP without risk for aspiration were allocated to either a CTRX or ABPC/SBT group based on the date of hospital admission. Macrolide was added to patients in each group. The primary outcome was the clinical response in the validated per-protocol (VPP) population at end of treatment (EOT). The secondary outcomes were clinical response during treatment and at end of study (EOS) in the VPP population, and mortality rate at day 30 in the modified intention-to-treat (MITT) population.

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“…The efficacy of 3 g/day sulbactam-ampicillin for 4 days against intermediate to severe community-acquired pneumonia has been reported (17). Highdose tigecycline and colistin are effective against pneumonia caused by carbapenemresistant Klebsiella pneumoniae in liver transplant patients (18).…”

mentioning

confidence: 99%

Efficacy of High-Dose Meropenem (Six Grams per Day) in Treatment of Experimental Murine Pneumonia Induced by Meropenem-Resistant Pseudomonas aeruginosa

Oshima

Nakamura

Iwanaga

et al. 2017

Antimicrob Agents Chemother

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High-dose meropenem (MEPM; 6 g/day) has been approved as a treatment for purulent meningitis; however, little is known regarding its in vivo efficacy in refractory lower respiratory tract infections. The purpose of this study was to evaluate the efficacy of MEPM at 6 g/day in a murine model of severe pneumonia caused by MEPM-resistant Pseudomonas aeruginosa. Experimental pneumonia induced by MEPM-resistant P. aeruginosa was treated with normal-dose MEPM (150 mg/kg of body weight, simulating a 3-g/day regimen in humans) or high-dose MEPM (500 mg/kg, simulating a 6-g/day regimen in humans). Mice treated with high-dose MEPM showed significantly restored survival relative to that of untreated mice and tended to show a survival rate higher than that of mice treated with normal-dose MEPM. The viable bacterial counts (of two clinical isolates) in the lungs decreased significantly in mice treated with high-dose MEPM from those for untreated mice (P Ͻ 0.001) or mice treated with normal-dose MEPM (P, Ͻ0.01 and Ͻ0.05). The number of inflammatory cells in the bronchoalveolar lavage fluid (BALF) was also significantly lower in mice treated with high-dose MEPM than in untreated mice. The free MEPM concentration in the epithelial lining fluid (ELF) exceeded 16 g/ml for 85 min in mice treated with high-dose MEPM, but not for mice treated with normal-dose MEPM. Our results demonstrate that high-dose MEPM (6 g/day) might provide better protection against pneumonia caused by MEPM-resistant strains of P. aeruginosa than the dose normally administered (less than 3 g/day).KEYWORDS high dose, meropenem, pharmacokinetics/pharmacodynamics, meropenem-resistant Pseudomonas aeruginosa P seudomonas aeruginosa is one of the major causes of hospital-acquired pneumonia (HAP) and opportunistic infections (1). HAP and bacteremia caused by P. aeruginosa can be fatal. A mortality rate of 47% has been reported for P. aeruginosa pneumonia patients. Mortality as a result of P. aeruginosa pneumonia is associated with a delay in initiating effective antimicrobial therapy and with multidrug-resistant P. aeruginosa (MDRP) (2, 3).Meropenem (MEPM) is an antimicrobial drug that is potent against P. aeruginosa; however, the incidence of MDRP has increased recently (4), and P. aeruginosa is the most common multidrug-resistant bacterial cause of hospital-acquired pneumonia

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Efficacy and safety of intravenous sulbactam/ampicillin 3 g 4 times daily in Japanese adults with moderate to severe community-acquired pneumonia: A multicenter, open-label, uncontrolled study

Cited by 7 publications

References 6 publications

Lower Body Mass Index is a Risk Factor for In-Hospital Mortality of Elderly Japanese Patients Treated with Ampicillin/sulbactam

Lower Body Mass Index is a Risk Factor for In-Hospital Mortality of Elderly Japanese Patients Treated with Ampicillin/sulbactam

Comparison of ceftriaxone plus macrolide and ampicillin/sulbactam plus macrolide in treatment for patients with community-acquired pneumonia without risk factors for aspiration: an open-label, quasi-randomized, controlled trial

Efficacy of High-Dose Meropenem (Six Grams per Day) in Treatment of Experimental Murine Pneumonia Induced by Meropenem-Resistant Pseudomonas aeruginosa

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