Patients enrolled in randomised clinical trials are not representative of critically ill patients in clinical practice: Observational study focus on tigecycline

Zimmermann, Johannes B.; Horscht, Julia J.; Weigand, Markus; Brückner, Thomas; Martin, Eike; Hoppe-Tichy, Torsten; Swoboda, Stefanie

doi:10.1016/j.ijantimicag.2013.07.016

Cited by 16 publications

(9 citation statements)

References 28 publications

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“…Despite that patients infected with multiresistant bacteria are not excluded from pivotal trials, they usually do not represent a large proportion of the whole patient population. Observational studies are particularly useful for the evaluation of substances that are used in indications and situations outside the scope covered by pivotal trials, e.g., in patients with high-risk profiles, multiple comorbidities, highly resistant pathogens, extensively pre-treated infections [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical efficacy of tigecycline used as monotherapy or in combination regimens for complicated infections with documented involvement of multiresistant bacteria

Heizmann¹,

Löschmann

Eckmann³

et al. 2014

Infection

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IntroductionTigecycline is an established treatment option for infections with multiresistant bacteria (MRB). It retains activity against many strains with limited susceptibility to other antibiotics. Efficacy and safety of tigecycline as monotherapy or in combination regimens were investigated in a prospective noninterventional study involving 1,025 severely ill patients in clinical routine at 137 German hospitals.Materials and methodsData on the full population have been published; our present analysis focuses on infections caused by MRB. The study population included patients with complicated infections, high disease severity (APACHE II > 15: 65 %) and high MRB prevalence. Most patients had comorbidities, including cardiovascular disease, renal insufficiency, and/or diabetes mellitus. Treatment success was defined as cure/improvement without requirement of further antibiotic therapy.ResultsPathogens isolated from 215 evaluable patients with documented MRB infections included 132 methicillin-resistant Staphylococcus aureus (MRSA), 42 vancomycin-resistant Enterococci (VRE) and 67 Gram-negative extended beta-lactamase (ESBL) producers. Of the MRB subpopulation, 140 patients received tigecycline monotherapy, 75 were treated with combination regimens. High overall clinical success rates were recorded for MRB infections treated with tigecycline alone (94 %) or in combinations (88 %); in detail intraabdominal infections (monotherapy: 90 %; combinations: 93 %), skin/soft tissue infections (93; 100 %), community-acquired pneumonia (100; 100 %), hospital-acquired pneumonia (94,7; 72,7 %), diabetic foot infections (89; 33 %), blood stream infections (100; 100 %) and multiple-site infections (92; 71 %).ConclusionsTigecycline achieved high clinical success rates in patients with documented infections involving MRB strains despite high disease severity. These results add to the evidence indicating that tigecycline is a valuable therapeutic option for complicated infections in severely ill patients with a high likelihood of multidrug-resistant pathogen involvement.

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Section: Discussionmentioning

confidence: 99%

Clinical efficacy of tigecycline used as monotherapy or in combination regimens for complicated infections with documented involvement of multiresistant bacteria

Heizmann¹,

Löschmann

Eckmann³

et al. 2014

Infection

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“…We make an urgent plea: the design of these trials should take into account that schedule regimens of antibiotics based on data from healthy volunteers or non-critically ill patients are clearly insufficient to treat severe infections. In addition, randomly assigned patients should be representative of those who will need these drugs [15]. …”

mentioning

confidence: 99%

High dose of tigecycline for extremely resistant Gram-negative pneumonia: yes, we can

Garnacho‐Montero

Ferrándiz-Millón

2014

Critical Care

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Few antimicrobials are currently active to treat infections caused by extremely resistant Gram-negative bacilli (ERGNB), which represent a serious global public health concern. Tigecycline, which covers the majority of these ERGNB (with the exception of Pseudomonas aeruginosa), is not currently approved for hospital-acquired pneumonia, and several meta-analyses have suggested an increased risk of death in patients receiving this antibiotic. Other studies suggest that the use of high-dose tigecycline may represent an alternative in daily practice. De Pascale and colleagues report that the clinical cure rate in patients with ventilator-associated pneumonia is significantly higher with a high dose of tigecycline than with the conventional dose, although mortality was unaffected. This high dose is safe; no patients required discontinuation or dose reduction.

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“…In a retrospective observational study, Peyrani et al observed a higher clinical success rate in patients receiving linezolid for the treatment of ventilator-associated pneumonia due to MRSA than in patients receiving vancomycin; resource utilization, on the other hand, was not different in the two groups of patients [ 14 ]. The necessity of such “real-life” studies has recently been pointed out by Zimmermann et al, who showed – using the example of tigecyclin – that individuals potentially eligible for participation in randomized controlled trials represent only a minority of the target population for antibiotics [ 15 ]. Critically ill patients, in particular, were found to be underrepresented.…”

Section: Introductionmentioning

confidence: 99%

Treatment of MRSA pneumonia: Clinical and economic comparison of linezolid vs. vancomycin – a retrospective analysis of medical charts and re-imbursement data of real-life patient populations

Wilke¹,

Becker²,

Kloss

et al. 2017

GMS Infectious Diseases; 5:Doc02

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Patients enrolled in randomised clinical trials are not representative of critically ill patients in clinical practice: Observational study focus on tigecycline

Cited by 16 publications

References 28 publications

Clinical efficacy of tigecycline used as monotherapy or in combination regimens for complicated infections with documented involvement of multiresistant bacteria

Clinical efficacy of tigecycline used as monotherapy or in combination regimens for complicated infections with documented involvement of multiresistant bacteria

High dose of tigecycline for extremely resistant Gram-negative pneumonia: yes, we can

Treatment of MRSA pneumonia: Clinical and economic comparison of linezolid vs. vancomycin – a retrospective analysis of medical charts and re-imbursement data of real-life patient populations

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