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A Multicentre Clinical Study on the Injection of Ceftriaxone/Sulbactam

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A Multicentre Clinical Study on the Injection of Ceftriaxone/Sulbactam Xin et al. Annals of Clinical Microbiology and Antimicrobials 2013, 12:38 http://www.ann-clinmicrob.com/content/12/1/38 RESEARCH Open Access A multicentre clinical study on the injection of ceftriaxone/sulbactam compared with cefoperazone/sulbactam in the treatment of respiratory and urinary tract infections Xiaojuan Xin1†, Li Jian2†, Xiaoying Xia2†, Bei Jia1*, Wenxiang Huang1, Chongzhi Li1, Changzheng Wang3, Lixin Zhou4, Xiuzhen Sun5, Xinghuo Tang6, Yijiang Huang7, Yunkui Zhu8 and Weili Zhang9 Abstract Objective: This clinical study was designed to evaluate the efficacy and safety of this therapy in the treatment of respiratory and urinary infections caused by ceftriaxone-resistant bacteria in comparison with the effect of cefoperazone/sulbactam on cefoperazone-resistant bacteria. Methods: A total of 285 patients aged from 18 to 65 years old, with a respiratory or urinary tract bacterial infection, were enrolled into this multicentre, open-label, controlled clinical study, and bacteria that were either ceftriaxone-resistant or cefoperazone-resistant were isolated from the patients, whose condition had not improved after three days of treatment with ceftriaxone or cefoperazone. To be selected for the study, bacterial cultures obtained from the patients had to be positive before enrolment, and all of the isolates were required to be β-lactamase-positive. Of these patients, 253 completed the trial, and 263 were enrolled into the intention-to-treat (ITT) analysis. All of the 285 patients were included in the safety analysis. Results: The cure and effective rates were 39.55% and 85.07% in the ceftriaxone/sulbactam group and 36.43% and 79.84% in the cefoperazone/sulbactam group; the bacterial eradication rates were 83.58% and 83.72%; and the adverse-event rates were 7.48% and 7.80%, respectively. There were no significant differences between the two groups (p > 0.05). Conclusion: Ceftriaxone/sulbactam is as effective and well-tolerated as cefoperazone/sulbactam for the treatment of intermediate and severe bacterial infections caused by resistant strains. Keywords: Resistant bacterial infection, Ceftriaxone/sulbactam, Multicentre clinical study Introduction (Mohnarin), the majority of the isolates detected (except Ceftriaxone was used in clinical practice for approximately Streptocococcus spp., Proteus mirabilis and Salmonella 30 years and was the first third-generation cephalosporin spp.) were highly resistant to ceftriaxone with a resistance approved for the once-daily treatment of patients with frequency ranging from 35%-70% [1]. gram-positive or gram-negative bacterial infections. How- Sulbactam is a molecule that is administered in combin- ever, based on data obtained from the Chinese Ministry of ation with β-lactam antibiotics to overcome the effects of Health National Antibacterial Resistance Surveillance Net β-lactamase. It is an irreversible inhibitor of β-lactamase that binds to the enzyme and prevents it from interacting * Correspondence: [email protected] with the antibiotic. Sulbactam is able to inhibit the most † Equal contributors common forms of β-lactamase and has been commercially 1Key Laboratory of Infectious and Parasitic Diseases in Chongqing, Department of Infectious Diseases, the First Affiliated Hospital of Chongqing available in combination with either ampicillin or cefoper- Medical University, No. 1 Youyi Road, Yu Zhong District, Chongqing 400016, azone [2]. China Full list of author information is available at the end of the article © 2013 Xin et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Xin et al. Annals of Clinical Microbiology and Antimicrobials 2013, 12:38 Page 2 of 8 http://www.ann-clinmicrob.com/content/12/1/38 The addition of sulbactam to ceftriaxone treatment Patients suffering from urinary tract infections (UTIs) were not only augments the activity of ceftriaxone against eligible for inclusion if they experienced at least two of the β-lactamase-producing bacteria but also maintains its following symptoms: fever, urinary irritation symptoms cost-effectiveness (once or twice daily administration). (dysuria, frequency, and urgency), suprapubic pain, costo- A number of studies have been conducted on the pharma- vertebral tenderness or flank pain, or the presence of more cokinetics or in vitro susceptibility of this combination than five leucocytes per high-power field in a centrifuged [3-7]. However, few clinical trials have reported on the sediment. The judgement of severity of respiratory or effects of using this new agent for the treatment of respira- urinary tract conditions was based on symptoms, signs and tory and urinary infections caused by ceftriaxone-resistant laboratory examinations of the patients according to the bacteria. criteria from Practice of Internal Medicine [8]. Our study was undertaken to evaluate the clinical effi- cacy and safety of injection with a fixed ratio (4:1) of this Key exclusion criteria β-lactam/β-lactamase inhibitor combination, as well as a Patients were excluded from the study if they had a history comparison to cefoperazone/sulbactam (2:1) injection, in of previous allergy to β-lactam antibiotics, had participated the treatment of respiratory and urinary tract infections in a new drug trial in the previous three months, had a caused by resistant bacteria. This investigation was con- history of severe cardiac, renal or haematological impair- ducted at eight medical centres in China over 5 years. ment, or had increased hepatic enzyme levels >2 times the upper limit of the normal range. Patients with a terminal Patients and methods malignancy or psychiatric illness, as well as women who Study design were pregnant or nursing, were also excluded. This multicentre, open-label, single-blinded, controlled clinical trial was undertaken in eight Chinese teaching Drug administration hospitals from 2005 to 2009. All of the cases were of Patients were assigned to receive intravenous injections intermediate or severe infection caused by ceftriaxone- with either 2.5 g of ceftriaxone/sulbactam or 4.5 g of resistant or cefoperazone-resistant bacteria. The protocol cefoperazone/sulbactam twice daily for 7–14 days. was approved by the appropriate ethics committees in each hospital and conducted in compliance with the Assessment and monitoring Declaration of Helsinki. Clinical assessments, including the symptoms and signs, of all of the patients were performed throughout the medi- Key inclusion criteria cation period. Laboratory assessments, including routine The selected inpatients or outpatients ranged in age haematology, chemistry and urinalysis profiles, electrocar- from 18 to 65 years old. They exhibited evidence of a diogram, chest X-rays and cultures of expectorated respiratory or urinary tract bacterial infection that sputum or urine were performed at the time of enrolment required antimicrobial treatment for more than three and one day after the completion of the therapy. The days. Their condition had not improved after three days safety and tolerability were assessed by observation and by of treatment with ceftriaxone or cefoperazone. To be volunteered reports from the patients. Adverse events selected for the study, bacterial cultures obtained from were documented with the concomitant medications. the patients had to be positive before enrolment, and all Women of childbearing potential were required to exhibit of the isolates were required to be β-lactamase-positive. normal menstruation and a negative pregnancy test. The In patients selected for the treatment group, the isolates patients with a cured or markedly improved clinical were resistant to ceftriaxone but sensitive to ceftriaxone/ outcome were followed up 7 days after the treatment for sulbactam, whereas in patients selected for the control microbiological, efficacy and safety assessments. group, the isolates were resistant to cefoperazone but Specimens were isolated from the sputum or urine for sensitive to cefoperazone/sulbactam. An informed con- bacterial culture prior to the initial treatment, on the first sent statement, which was approved by the local ethical day of treatment and on the 7th day after the completion of review board, was signed before enrolment in the trial. the therapy. The Kirby-Bauer disc diffusion method and The diagnosis and judgment of the condition of bacterial the minimum inhibitory assay (broth dilution method) were infection were based on the symptoms, signs and related conducted to test the susceptibility of all of the isolates to laboratory examinations. The patients included in the study six antimicrobials, including ceftriaxone, ceftriaxone/sul- who suffered from respiratory tract infections (RTIs) were bactam, cefoperazone, cefoperazone/sulbactam, cefepime required to exhibit radiographic evidence and at least two and imipenem/cilastin. The judgment of microbial suscepti- of the following symptoms: fever (>37°C) or hypothermia, bility was determined according to the CLSI 2005–2009 cough with sputum, dyspnea, crackles, rales, pleuritic pain, guidelines, and the susceptibility rate was calculated based dullness of percussion, and leucocytosis or leucopenia. on standards [9]. The minimum inhibitory concentrations Xin et al. Annals of Clinical Microbiology and Antimicrobials 2013, 12:38 Page 3 of 8 http://www.ann-clinmicrob.com/content/12/1/38
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