Treatment of hospitalized patients with complicated skin and skin structure infections: double-blind, randomized, multicenter study of piperacillin-tazobactam versus ticarcillin-clavulanate. The Piperacillin/Tazobactam Skin and Skin Structure Study Group

Tan, James S.; Wishnow, Rodney M.; Talan, David A.; Duncanson, Frederick P.; Norden, Carl W.

doi:10.1128/aac.37.8.1580

Cited by 81 publications

(36 citation statements)

References 6 publications

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“…This approach is in contrast to the more common approach which allows for a cure, improved, or failed outcome as assessment options. A multicenter study with ticarcillin-clavulanate versus piperacillin-tazobactam in patients with complicated skin and skin structure infections (half of which were graded severe) demonstrated a 61% cure rate in both treatment groups (similar to the present study), while another 16 and 15% were considered improved, respectively (35). Stricter criteria for patient evaluability and handling of nonstudy antibacterial therapy may also have resulted in fewer patients being classified as evaluable cures, since patients who received nonprotocol antibacterials were considered treatment failures rather than nonevaluable.…”

Section: Discussionsupporting

confidence: 59%

“…These rates are somewhat lower than the pathogen eradication rates previously reported in a comparison of piperacillin-tazobactam (76%) and ticarcillin-clavulanate (82.8%) (35). The lower rates may reflect the greater number of baseline isolates of P. aeruginosa and enterococci in the present study and the strict criteria used to assess pathogen response, in that persistence (rather than unevaluability) was assessed if the patient received nonantibiotics or was otherwise felt to be clinically failing protocol.…”

Section: Discussioncontrasting

confidence: 51%

“…; and anaerobes such as Bacteroides fragilis are frequently isolated (8,12,13,18,32 Frequently used antimicrobial agents have included expandedspectrum cephalosporins (e.g., cefoxitin, cefotetan, cefmetazole), imipenem-cilastatin, ␤-lactam-␤-lactamase inhibitor combinations (e.g., piperacillin-tazobactam, ticarcillin-clavulanate), and fluoroquinolones (13,14,15,18,20,35). However, emerging resistance, particularly among S. aureus, P. aeruginosa, and enterococci, is making the choice of treatment increasingly more difficult (23).…”

mentioning

confidence: 99%

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Clinafloxacin versus Piperacillin-Tazobactam in Treatment of Patients with Severe Skin and Soft Tissue Infections

Siami

Christou

Eiseman³

et al. 2001

Antimicrob Agents Chemother

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Patients (n ‫؍‬ 409) with severe skin and soft tissue infections (SSTIs) were randomized to receive clinafloxacin or piperacillin-tazobactam (plus optional vancomycin for methicillin-resistant cocci), administered intravenously, with the option to switch to oral medication. Most patients had cellulitis, wound infections, or diabetic foot infections. Staphylococcus aureus, Enterococcus faecalis, and Pseudomonas aeruginosa were the most common baseline pathogens. Fewer baseline pathogens were resistant to clinafloxacin (1.8%) than to piperacillin-tazobactam (6.2%) (P ‫؍‬ 0.001). The clinafloxacin and piperacillin-tazobactam groups did not differ significantly in clinical cure rates (68.8 and 65.2%, respectively) or microbiologic eradication rates (61.5 and 57.2%). Clinafloxacin yielded higher eradication rates for all three of the most common pathogenic species, although no differences were statistically significant. Within the power of this study, the overall frequency of adverse events was similar (P ‫؍‬ 0.577) in the two treatment groups. Drug-associated adverse events (P ‫؍‬ 0.050) and treatment discontinuations (P ‫؍‬ 0.052) were marginally more frequent in the clinafloxacin group, primarily due to phototoxicity in outpatients receiving clinafloxacin. Although most cases of phototoxicity were mild to moderate, four cases were reported as severe. In summary, clinafloxacin monotherapy was equivalent in effectiveness to therapy with piperacillin-tazobactam plus optional vancomycin in the treatment of hospitalized patients with severe SSTIs.Skin and soft tissue infections (SSTIs), such as spontaneous lymphangitis or cellulitis, and especially complicated infections, such as wound and surgical infections or diabetic foot ulcers, often require hospitalization and intravenous (i.v.) antibacterial treatment. These infections are caused by a mixture of aerobic and anaerobic organisms and are responsible for increased morbidity, prolonged hospital stay, and increased health care costs (3,13,19).Staphylococcus aureus and streptococci; gram-negative bacteria such as Pseudomonas aeruginosa, Enterobacteriaceae, and Enterococcus spp.; and anaerobes such as Bacteroides fragilis are frequently isolated (8,12,13,18,32 Frequently used antimicrobial agents have included expandedspectrum cephalosporins (e.g., cefoxitin, cefotetan, cefmetazole), imipenem-cilastatin, ␤-lactam-␤-lactamase inhibitor combinations (e.g., piperacillin-tazobactam, ticarcillin-clavulanate), and fluoroquinolones (13,14,15,18,20,35). However, emerging resistance, particularly among S. aureus, P. aeruginosa, and enterococci, is making the choice of treatment increasingly more difficult (23).Clinafloxacin is an extended-spectrum fluoroquinolone antibacterial that is bactericidal against S. aureus, including methicillin-resistant strains, and most strains of ciprofloxacinresistant S. aureus (7,33). Like other fluoroquinolones, clinafloxacin has activity against Pseudomonas spp. and the Enterobacteriaceae; the MICs of clinafloxacin at which 90% of isolates are ...

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Section: Discussionsupporting

confidence: 59%

Section: Discussioncontrasting

confidence: 51%

mentioning

confidence: 99%

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Clinafloxacin versus Piperacillin-Tazobactam in Treatment of Patients with Severe Skin and Soft Tissue Infections

Siami

Christou

Eiseman³

et al. 2001

Antimicrob Agents Chemother

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“…Piperacillin in combination with tazobactam has been shown to be effective in the treatment of a variety of infections in a variety of settings, including intra-abdominal sepsis infections associated with febrile neutropenia, skin and soft tissue infections, and nosocomial pneumonia (7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18). It is likely that this drug will be used widely for the treatment of polymicrobial infections caused by piperacillin-susceptible organisms and organisms producing one of the of beta-lactamase susceptible to tazobactam.…”

Section: Discussionmentioning

confidence: 99%

Study of the Comparative Activity of Piperacillin/Tazobactam with Currently Available Antibiotics against 8206 Aerobic Isolates

Forward

Low²,

Laverdière³

et al. 1996

Canadian Journal of Infectious Diseases and Medical Microbiolog

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OBJECTIVES:To compare the activity of piperacillin-tazobactam with piperacillin and other parenterally administered antibiotics against aerobic Gram-negative bacilli and Gram-positive cocci isolated from across Canada, and to determine the prevalence of resistance mediated by extended-spectrum cephalosporinases. METHODS: Sixty-one laboratories participated. Disk diffusion testing was performed in accordance with methods outlined by the National Committee for Clinical Laboratory Standards. Susceptibilities were performed on 8206 strains. Escherichia coli and Klebsiella pneumoniae with reduced susceptibilities to third-generation cephalosporins were screened for extended-spectrum beta-lactamases (ESBLs). RESULTS: Piperacillin-tazobactam was active against 92% of the strains, piperacillin against 81% and ticarcillinclavulanic acid against 88%. Few differences were observed in the relative susceptibility of strains from teaching or community hospitals, from different anatomic sites or from different regions of the country. Aerobic Gram-negative bacilli tested tended to be more susceptible to all the agents than was recently reported in a similar American study. Only 43% of Enterococcus faecium were susceptible to ampicillin and 42% to piperacillin piperacillin with and without tazobactam. Only two enterococcal strains were resistant to vancomycin, and 19 had intermediate zone sizes. Of the 10 strains of E coli and eight strains of K pneumoniae with reduced susceptibility to extended spectrum cephalosporins, only one demonstrated typical ESBL activity. CONCLUSIONS: Canadian aerobic Gram-positive cocci and Gram-negative bacilli remain highly susceptible to many currently available antibiotics. The findings confirm a broad spectrum of activity of piperacillin-tazobactam and indicate that the pattern of susceptibility is quite uniform from different body sites, in both teaching and community hospitals, and across the country.

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“…The beta-lactam antibiotics are among the most widely prescribed classes of drugs for infants and children. For decades these drugs have been used successfully for the treatment of most bacterial infections arising in childhood, particularly for those infections involving skin and soft tissues, the genitourinary tract, the upper and lower respiratory tracts, and the central nervous system (30,31). Unfortunately, over the last decade, the number of infections caused by penicillinand cephalosporin-resistant bacteria has increased dramatically, reducing the clinical utilities of these safe and previously very effective antibiotics (22,29).…”

mentioning

confidence: 99%

Single-dose pharmacokinetics of piperacillin and tazobactam in infants and children

Reed

Goldfarb

Yamashita

et al. 1994

Antimicrob Agents Chemother

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The pharmacokinetics of piperacillin and tazobactam were assessed after single-dose administration to 47 infants and children. Study subjects ranging in age from 2 months to 12 years were randomized to receive one of two different doses of a piperacillin-tazobactam combination (8:1): a low dose (n = 23) of 50 and 6.25 mg of piperacillin and tazobactam per kg of body weight, respectively, or a high dose (n = 24) of 100 and 12.5 mg, respectively. The pharmacokinetic behavior of tazobactam was very similar to that observed for piperacillin, supporting the use of these two agents in a fixed-dose combination. No differences in the pharmacokinetics of piperacillin or tazobactam were observed between the two doses administered. The elimination parameters half-life and total body clearance decreased and increased, respectively, with increasing age, whereas volume parameters (volume of distribution and steady-state volume of distribution) remained relatively constant for both compounds. The primary metabolite of tazobactam, metabolite Ml, was measurable in the plasma of 18 of the 47 study subjects; 17 of these 18 subjects received the high doses. More than 70%o of the administered piperacillin and tazobactam doses were excreted unchanged in the urine over a 6-h collection period. These data combined with the known in vitro susceptibilities of a broad range of pediatric bacterial pathogens indicate that a dose of 100 mg of piperacillin and 12.5 of mg tazobactam per kg of body weight administered as a fixed-dose combination every 6 to 8 h would be appropriate to initiate clinical efficacy studies in infants and children for the treatment of systemic infections arising outside of the central nervous system. The beta-lactam antibiotics are among the most widely prescribed classes of drugs for infants and children. For decades these drugs have been used successfully for the treatment of most bacterial infections arising in childhood, particularly for those infections involving skin and soft tissues, the genitourinary tract, the upper and lower respiratory tracts, and the central nervous system (30,31). Unfortunately, over the last decade, the number of infections caused by penicillinand cephalosporin-resistant bacteria has increased dramatically, reducing the clinical utilities of these safe and previously very effective antibiotics (22,29). By 1975 nearly 85% of all isolates of Staphylococcus aureus were resistant to penicillin (22), and a similar trend has been observed for Haemophilus influenzae and Moraxella catarrhalis, in which nearly 40% of all H. influenzae type B strains and more than 80% of M. catarrhalis isolates are resistant to ampicillin (6, 29). Moreover, variable and changing susceptibility patterns to a wide range of penicillin and cephalosporin antibiotics are observed for other gram-negative pathogens (6,22,29).Bacterial resistance to beta-lactam antibiotics is most often mediated via one of three primary mechanisms; alterations in drug binding to their cellular targets, the penicillin-binding proteins; alt...

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Treatment of hospitalized patients with complicated skin and skin structure infections: double-blind, randomized, multicenter study of piperacillin-tazobactam versus ticarcillin-clavulanate. The Piperacillin/Tazobactam Skin and Skin Structure Study Group

Cited by 81 publications

References 6 publications

Clinafloxacin versus Piperacillin-Tazobactam in Treatment of Patients with Severe Skin and Soft Tissue Infections

Clinafloxacin versus Piperacillin-Tazobactam in Treatment of Patients with Severe Skin and Soft Tissue Infections

Study of the Comparative Activity of Piperacillin/Tazobactam with Currently Available Antibiotics against 8206 Aerobic Isolates

Single-dose pharmacokinetics of piperacillin and tazobactam in infants and children

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