PMID: 8959115Nov 1, 1996Paper

Time to resolution of morbidity: an endpoint for assessing the clinical cure of community-acquired pneumonia

Respiratory Medicine
R DaifukuS Nelson

Abstract

Clinical trials of new therapeutics for community-acquired pneumonia (CAP) have typically used a subjective endpoint of clinical response. However, as this endpoint is not quantitative, it is subject to observer bias and renders the conduct of multicenter trials difficult. For the purposes of conducting a clinical trial of filgrastim, as an adjunct to antibiotics for the treatment of CAP, a set of clinical criteria were developed prospectively to determine the time when a clinical cure was achieved, based on respiratory rate, temperature, oxygenation and roentgenographic findings, which was termed the time to resolution of morbidity (TRM). The TRM was evaluated on the first 100 patients entered in this clinical trial. As no clear reference standard exists, the predictive value for the duration of parenteral antibiotics (AB) and the length of hospital stay (LOS) was compared with that provided by a widely used classification system for severity of disease, APACHE II. The TRM was found to correlate significantly better with AB or LOS than APACHE II (P < 0.001). Furthermore, TRM offers the benefit over the endpoints of LOS and AB of being specifically designed to measure the patient's response to therapy, and, in fact, may aid phy...Continue Reading

References

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Citations

Apr 15, 2005·Pharmacological Research : the Official Journal of the Italian Pharmacological Society·Brian LauritzenOve Svendsen
Jul 14, 2006·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·N DanemanUNKNOWN Toronto Invasive Bacterial Diseases Network
Feb 6, 2007·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Lionel A MandellUNKNOWN American Thoracic Society
Jan 1, 2005·Surgical Infections·Reza Askari, Robert G Sawyer
Mar 17, 2011·Critical Care : the Official Journal of the Critical Care Forum·Silvia Fernández-SerranoFrederic Manresa
Oct 23, 2001·Respiratory Research·J K Kolls, S Nelson
Oct 16, 2007·Chest·Rosario Menendez, Antoni Torres
Oct 21, 1998·Infectious Disease Clinics of North America·S Nelson, W R Summer
Feb 24, 2001·Emergency Medicine Clinics of North America·R Roberts
Oct 5, 2001·The American Journal of Medicine·A Castro-GuardiolaF García-Bragado
Nov 5, 2002·Respiratory Medicine·R K AilaniB DiGiovine

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