Antibiotic Susceptibility Testing Using the Standard vs. the Biofilm Method
Funding for this trial has been provided in full or in part by Cystic Fibrosis Foundation Therapeutics, Inc.
Multiple systemic antibiotics
Number of Participants Being Recruited:
Single / Multi-Center:
STUDY BACKGROUND INFORMATION:
This study compared the effectiveness of selecting antibiotic treatments through either a standard laboratory test or a new testing method. Determining the effect of various antibiotics on bacteria found in patientsâ?? lungs is vital for selecting an treatment strategy. In people with CF, bacteria grow in the lungs creating a biofilm (a protective coating). Standard laboratory methods to determine the effect of antibiotics on bacteria may not truly reflect response that bacteria may have when they exist as a biofilm. Adult volunteers with CF who have lung infections caused by the P. aeruginosa bacteria were treated with various antibiotics selected by using either the standard or biofilm testing method. The usefulness of the tests were assessed at the end of the treatment period by measuring decrease in numbers of bacteria and improvement in lung function.
>= 18 Years
P. aeruginosa status:
B. cepacia status:
Other Primary Eligibility Requirements:
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
Thirty-nine participants were randomized to biofilm or conventional treatment groups, and 14-day courses of two antibiotics were selected according to an activity-based algorithm using the corresponding susceptibility results. For nineteen of 39 randomized participants, randomization to the other study group would not have changed the antibiotic classes of the assigned regimen. Study groups were comparable at baseline, and had similar mean decreases in bacterial density, measured in log10 colony forming units per gram of sputum (biofilm, -2.94 [SD 2.83], versus conventional, -3.27 [SD 3.09]), and mean increases in forced expiratory volume in one second, measured in liters (0.18 [SD 0.20] versus 0.12 [SD 0.22]). In this pilot study, antibiotic regimens based on biofilm testing did not result in significantly different microbiological and clinical responses than regimens based on conventional testing.
Study groups also had similar mean increases in FEV1 (L).
Thirteen participants in each group experienced >1 adverse event, none serious.