title: Catheter-tip colonization as a surrogate end point in clinical studies on catheter-related bloodstream infection: how strong is the evidence?
abstract: In clinical trials, the incidence of catheter-tip colonization (CTC) is frequently used as a surrogate end point for the incidence of catheter-related bloodstream infection (BSI). It is not clear whether the correlation between CTC and catheter-related BSI is good. We searched the MEDLINE database and conducted a literature search for the years 1990-2002 and retrieved 29 studies (with a total of 60 study groups) with incidence data on predefined CTC and catheter-related BSI definitions. A good linear correlation between CTC and catheter-related BSI was found (r=0.69; r2=0.48; P<.001). The data from the medical literature about catheter-related infection seem to support the use of CTC as a surrogate end point for catheter-related BSI. In evaluations of clinical interventions or new techniques for the prevention of catheter-related BSI, investigation of the prevention of CTC seems to be a logical first step.
authors.affiliation: Department of Internal Medicine and Infectious Diseases, Universitaire Ziekenhuizen Leuven, B-3000 Leuven, Belgium. bart.rijnders@uz.kuleuven.ac.be
authors.forename: Bart J A
authors.initials: BJ
authors.lastname: Rijnders
authors.forename: Eric
authors.initials: E
authors.lastname: Van Wijngaerden
authors.forename: Willy E
authors.initials: WE
authors.lastname: Peetermans
mesh_terms: D015415:Biomarkers / Q000097:blood; D001769:Blood / Q000382:microbiology*; D002404:Catheterization / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D006801:Humans; D008297:Male; D016459:Prosthesis-Related Infections / Q000097:blood* / Q000382:microbiology
chemical_list: D015415:Biomarkers