R. Daifuku et al., TIME TO RESOLUTION OF MORBIDITY - AN END-POINT FOR ASSESSING THE CLINICAL CURE OF COMMUNITY-ACQUIRED PNEUMONIA, Respiratory medicine, 90(10), 1996, pp. 587-592
Citations number
16
Categorie Soggetti
Cardiac & Cardiovascular System","Respiratory System
Clinical trials of new therapeutics for community-acquired pneumonia (
CAP) have typically used a subjective endpoint of clinical response. H
owever, as this endpoint is not quantitative, it is subject to observe
r bias and renders the conduct of multicenter trials difficult. For th
e purposes of conducting a clinical trial of filgrastim, as an adjunct
to antibiotics for the treatment of CAP, a set of clinical criteria w
ere 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 ente
red 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 th
an 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 physicians in de
termining the duration of parenteral antibiotic therapy. Hence, TRM is
relevant to the clinician and is a useful tool to ensure uniformity i
n the assessment of the response to a new therapeutic in a multicenter
clinical trial.