Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens (BOLERO)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01022944
First received: September 30, 2009
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Chronic Serous Otitis Media, Simple or Unspecified
Procedure: With chronic middle ear effusion
Procedure: Without chronic middle ear effusion
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Prevalence of Mucosal Biofilm Formations in Adenoidectomy Specimens. A Case Control Study

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Prevalence of mucosal biofilm formations in adenoidectomy specimens analyzed using Confocal Laser Scanning Microscopy with double staining [ Time Frame: at 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To build up a tissue bank of human tissue from adenoids and the middle ear for further bacterial identification [ Time Frame: during the study ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: July 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 2 :
Children without chronic middle ear effusion as a control group having adenoids removed for chronic obstruction.
Procedure: Without chronic middle ear effusion
Children without chronic middle ear effusion as a control group having adenoids removed for chronic obstruction.
Group 1
Children with chronic middle ear effusion having adenoidectomy.
Procedure: With chronic middle ear effusion
Children with chronic middle ear effusion having adenoidectomy.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Group 1 and 2

    • obtained informed consent by both parents and child (if possible),
    • age > 18 months and <10 years
    • chronic serous otitis media lasting more than 3 months (group 1).
  • Group 1 only:

    • chronic secretory otitis media
  • Group 2 only:

    • hypertrophia adenoid vegetations without sinusal oropharyngeal infections

Exclusion criteria:

  • No informed consent
  • age < 18 months or > 10 years
  • Eustachian tube dysfunction
  • Immunodeficiency
  • Tumor
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022944

Locations
France
Hôpital ROBERT DEBRE - ORL Pédiatrique
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Romain KANIA, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01022944     History of Changes
Other Study ID Numbers: P080605
Study First Received: September 30, 2009
Last Updated: February 20, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Serous otitis media
Biofilm
Adenoidectomy
Chronic otitis media

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 19, 2014