Improved treatment of multidrug-resistant bacterial infections : utility of clinical studies

In a time of increasing antibacterial resistance and limited availability of new antibiotics, clinical studies are much needed to assess treatment options against multidrug-resistant organisms (MDROs). In this review, we describe the clinical challenge caused by MDROs and present recent evidence on how clinical studies may generate quality data to improve antibiotic treatment of MDRO infections. To this aim, we critically assess the current status, gaps and challenges associated with observational and interventional studies performed to assess MDRO treatment options. We address why observational studies are useful, which treatment options for MDRO have been explored by observational studies and how to improve quality and usefulness of observational studies. Furthermore, the utility of clinical pharmacokinetic/pharmacodynamic studies for improving MDRO treatment is described. Finally, we discuss interventional study designs, end points and margins, as well as ethical, logistic and statistical challenges, and current regulatory changes proposed to foster the development of new antibiotics.

Medienart:

E-Artikel

Erscheinungsjahr:

2014

Erschienen:

2014

Enthalten in:

Zur Gesamtaufnahme - volume:9

Enthalten in:

Future microbiology - 9(2014), 6 vom: 28., Seite 757-71

Sprache:

Englisch

Beteiligte Personen:

Bettiol, Esther [VerfasserIn]
Rottier, Wouter C [VerfasserIn]
Del Toro, Maria Dolores [VerfasserIn]
Harbarth, Stephan [VerfasserIn]
Bonten, Marc J [VerfasserIn]
Rodríguez-Baño, Jesús [VerfasserIn]
COMBACTE consortium [VerfasserIn]

Links:

Volltext

Themen:

Anti-Bacterial Agents
Antibacterial resistance
Antibacterial treatment
Clinical trials
Epidemiology
Interventional
Journal Article
Multidrug-resistant organisms
Observational
Pharmacokinetic/pharmacodynamic
Regulatory guidance
Research Support, Non-U.S. Gov't
Review
Study design

Anmerkungen:

Date Completed 30.03.2015

Date Revised 22.07.2014

published: Print

Citation Status MEDLINE

doi:

10.2217/fmb.14.35

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM240275500