Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01022944 |
| Other study ID # |
P080605 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2010 |
| Est. completion date |
May 2012 |
Study information
| Verified date |
May 2021 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Rationale: Bacterial biofilms are defined as an assemblage of bacterial cells enclosed in a
self-produced glycocalyx matrix. Adherence on surfaces, and resistance to both antibiotic
treatments and host defenses are ones of the major clinical features of bacterial biofilms.
Hence, biofilm formations represent a serious clinical problem: they persist in human tissues
and play a role in a large number of chronic and resistant infections. It has been estimated
that more than 65% of all human bacterial infections involve biofilms. Recently, the
investigators have demonstrated the presence of mucosal bacterial biofilms in adenoid tissues
removed during routine adenoidectomy. Bacterial biofilms were visualized using Confocal Laser
Scanning Microscopy (CLSM) with a technique of double staining showing both the bacterial
cells and the glycocalyx matrix. Although this study clearly established that adenoids
tissues can harbour mucosal biofilms, the prevalence of 54% the investigators found suggested
that some groups of children may contain more biofilm formations than others. In an effort to
relate the findings of mucosal biofilm with the clinical presentation, the investigators have
designed the present work to compare the prevalence of mucosal biofilms in adenoidectomy
specimens in two groups: one group of children with chronic otitis media (COM) with effusion
versus another group of children without any COM, having adenoids removed for chronic
obstruction.
Description:
The aim of this case-control study is to compare the prevalence of biofilms formations in
adenoid tissues of children with COM versus a control group without any COM.
Design: This is a monocentric, prospective, unrandomized case-control study comparing the
prevalence of biofilm formations in adenoid tissues of two groups.
Clinical research study without direct medical benefit: during routine adenoidectomy,
specimens are not used and thrown away. This study do not modify the common management of
included children.
Number of subjects required: A considered approach of simple size calculation have been made
using a method proposed by MIETINEN for Mc NEMAR Chi2 test. Simple size N=104 will allow 80%
power to detect different of 20% (absolute), considering a total percentage of discordance
pair at 30 %.
Expected results: a higher prevalence (30% estimation) of biofilm formations in group 1 in
comparison with that in group 2 would be the first clinical research study bringing
understanding of the role of adenoid tissues by harboring mucosal biofilms in otitis prone
children.
