Safety and Efficacy of Intravenous Tigecycline in Subjects with Secondary Bacteremia: Pooled Results from 8 Phase III Clinical Trials

Gardiner, David F.; Dukart, Gary; Cooper, Angel; Babinchak, Timothy

doi:10.1086/648720

Cited by 88 publications

(48 citation statements)

References 51 publications

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“…Four articles were excluded because they were part of other RCTs already included in this meta-analysis (e.g., data from European study sites that participated in a larger trial) (12,17,30,44). Another two articles were excluded because they were combinations of RCTs already included in this meta-analysis (18,42). Thus, eight RCTs were included in the meta-analysis (Fig.…”

Section: Resultsmentioning

confidence: 99%

Systematic Review and Meta-Analysis of the Effectiveness and Safety of Tigecycline for Treatment of Infectious Disease

Cai

Wang

Liang

et al. 2011

Antimicrob Agents Chemother

171

103

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The aim of this study was to compare the efficacy and safety of tigecycline, a newly developed glycylcycline antibiotic, with those of empirical antibiotic regimens which have been reported to possess good efficacy for complicated skin and skin structure infections (cSSSIs), complicated intra-abdominal infections (cIAIs), community-acquired pneumonia (CAP), and other infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE CI ‫؍‬ 0.69 to 1.07, P ‫؍‬ 0.19). The incidence of adverse events in the tigecycline group was significantly higher than that in the other therapy groups with a statistical margin (for the modified intent-to-treat [mITT] population, OR ‫؍‬ 1.33, 95% CI ‫؍‬ 1.17 to 1.52, P < 0.0001), especially in the digestive system (mITT population, OR ‫؍‬ 2.41, 95% CI ‫؍‬ 1.67 to 3.46, P < 0.00001). No difference regarding all-cause mortality and drug-related mortality between tigecycline and the other regimens was found, although numerically higher mortality was found in the tigecycline group. This meta-analysis provides evidence that tigecycline monotherapy may be used as effectively as the comparison therapy for cSSSI, cIAIs, CAP, and infections caused by MRSA/VRE. However, because of the high risk of mortality, AEs, and emergence of resistant isolates, prudence with the clinical use of tigecycline monotherapy in infections is required.The threat of antimicrobial resistance has been identified as one of the major challenges facing public health, and antimicrobial resistance has increased rates of morbidity and mortality and socioeconomic costs. The rapid rate of microbial evolution underscores the urgent need for development of new agents that overcome existing mechanisms of resistance displayed by multidrug-resistant bacteria.Tigecycline is a first-in-class expanded-broad-spectrum glycylcycline. It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit but with a five times higher affinity than that for the tetracyclines (4). In vitro studies demonstrate that it has good activity against many commonly encountered respiratory bacteria, including multiple resistant Gram-positive, Gram-negative, anaerobic, as well as multidrug-resistant (MDR) pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant Staphylococcus epidermidis (MRSE), vancomycin-resistant Enterococcus (VRE), penicillin-resistant Streptococcus pneumoniae (PRSP), and ␤-lactamase-producing Haemophilus influenzae, among others (5). Tigecycline overcomes the two key tetracycline resistance mechanisms (efflux pumps and ribosomal protection) and is unaffected by other bacterial mechanisms of resistance, such as extended-spectrum ␤-lactamases (32).Tigecycline was first approved for use for indications of complicated skin and skin structure infections (cSSSIs) and complicated intra-abdominal infections (cIAIs). Currently, it is approved for use for community-acquired pneumonia (CAP). It has also been found to be effective for the trea...

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Section: Resultsmentioning

confidence: 99%

Systematic Review and Meta-Analysis of the Effectiveness and Safety of Tigecycline for Treatment of Infectious Disease

Cai

Wang

Liang

et al. 2011

Antimicrob Agents Chemother

171

103

View full text Add to dashboard Cite

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“…While tigecycline often has a low MIC (Ͻ2 g/ml) for A. baumannii strains, the drug's serum concentrations are also low, and in clinical trials, outcomes in patients with ventilator-associated pneumonia and bacteremia have been clearly inferior to alternative agents (230)(231)(232). In particular, retrospective clinical data validate the susceptibility breakpoint of tigecycline at 2 g/ml.…”

Section: Current Treatment Optionsmentioning

confidence: 99%

Clinical and Pathophysiological Overview of Acinetobacter Infections: a Century of Challenges

et al. 2017

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SUMMARY Acinetobacter is a complex genus, and historically, there has been confusion about the existence of multiple species. The species commonly cause nosocomial infections, predominantly aspiration pneumonia and catheter-associated bacteremia, but can also cause soft tissue and urinary tract infections. Community-acquired infections by Acinetobacter spp. are increasingly reported. Transmission of Acinetobacter and subsequent disease is facilitated by the organism's environmental tenacity, resistance to desiccation, and evasion of host immunity. The virulence properties demonstrated by Acinetobacter spp. primarily stem from evasion of rapid clearance by the innate immune system, effectively enabling high bacterial density that triggers lipopolysaccharide (LPS)–Toll-like receptor 4 (TLR4)-mediated sepsis. Capsular polysaccharide is a critical virulence factor that enables immune evasion, while LPS triggers septic shock. However, the primary driver of clinical outcome is antibiotic resistance. Administration of initially effective therapy is key to improving survival, reducing 30-day mortality threefold. Regrettably, due to the high frequency of this organism having an extreme drug resistance (XDR) phenotype, early initiation of effective therapy is a major clinical challenge. Given its high rate of antibiotic resistance and abysmal outcomes (up to 70% mortality rate from infections caused by XDR strains in some case series), new preventative and therapeutic options for Acinetobacter spp. are desperately needed.

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“…33 Gardiner et al 33 reported that tigecycline was effective for patients with bacteremia associated with community-acquired bacterial pneumonia, complicated skin/skin-structure infections, and intraabdominal infections; however, only 6 patients in the tigecycline group had MRSA bacteremia. Adverse effects include severe nausea and vomiting, severe skin reactions, QT prolongation, pancreatitis, and hepatotoxic effects.…”

Section: Definitionmentioning

confidence: 99%

Treating Central Catheter–Associated Bacteremia Due to Methicillin-Resistant Staphylococcus aureus: Beyond Vancomycin

Holt

Thompson-Brazill

Sparks

et al. 2016

Critical Care Nurse

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Methicillin-resistant Staphylococcus aureus is a frequent cause of hospital-associated infections, including central catheter-associated bacteremia. Vancomycin has been the drug of choice for treating this type of bacteremia for decades in patients who have no contraindications to the antibiotic. However, resistance to vancomycin is an emerging problem. Newer antibiotics approved by the Food and Drug Administration have activity against methicillin-resistant S aureus. Some of the antibiotics also have activity against strains of S aureus that are intermediately susceptible or resistant to vancomycin. This article uses a case study to highlight the clinical signs of vancomycin failure and describes the indications for and appropriate use of alternative antimicrobials such as ceftaroline, daptomycin, linezolid, tigecycline, and telavancin. (Critical Care Nurse. 2016;36[4]:46-57) 1 S aureus is both a commensal skin organism and a pathogen. Colonization can lead to infection when a breach occurs in the skin or mucosal defense systems because of trauma or common procedures This article has been designated for CE contact hour(s). The evaluation tests your knowledge of the following objectives: 1. Discuss the signs of vancomycin failure in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) central catheter-associated bacteremia 2. Describe the indications for use of daptomycin and ceftaroline for treatment of MRSA central catheter-associated bacteremia 3. Verbalize at least 2 nursing interventions that help prevent MRSA central catheter-associated bacteremia

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Safety and Efficacy of Intravenous Tigecycline in Subjects with Secondary Bacteremia: Pooled Results from 8 Phase III Clinical Trials

Abstract: Tigecycline was generally safe and well tolerated in the treatment of secondary bacteremia associated with cSSSI, cIAI, and CAP; cure rates were similar to comparative standard therapies.

Cited by 88 publications

References 51 publications

Systematic Review and Meta-Analysis of the Effectiveness and Safety of Tigecycline for Treatment of Infectious Disease

Systematic Review and Meta-Analysis of the Effectiveness and Safety of Tigecycline for Treatment of Infectious Disease

Clinical and Pathophysiological Overview of Acinetobacter Infections: a Century of Challenges

Treating Central Catheter–Associated Bacteremia Due to Methicillin-Resistant Staphylococcus aureus: Beyond Vancomycin

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