Carriage of Streptococcus Pneumoniae in Infants With Acute Otitis Media and in Infants Attending Day-care Centers

NCT02888457 | Completed

• 1 other identifier: 15/45/471
• Study Type: interventional
• Target: 2,817
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale In Belgium, a unique situation exists for two reasons: on the one hand, the pneumococcal conjugate vaccine (PCV) program, which started in 2007, has quickly reached high coverage in infants: 3-dose coverage rose from 89 % in 2008 to 96.5 % in 2012 in Flanders and from 80.7 % in 2009 to 89.2 % in 2012 in Wallonia; and on the other hand, serotype coverage has moved from PCV7 (since 2007) to PCV13 (since 2011) and very recently to PCV10 (since July 2015 in Flanders and expected in May 2016 in the French Community). Invasive pneumococcal disease (IPD) surveillance has demonstrated a major impact on PCV13 serotypes in infants \< 2 years of age. The impact of the current change in PCV-program is hard to predict, but could eventually result in a re-emergence of serotypes not covered by PCV10 (i.e. 3, 6A and 19A). With this unique situation the foundation was laid for a carriage study during which the nasopharyngeal carriage of Streptococcus pneumonia (Sp) and other common colonizers of the nasopharynx will be studied in infants with acute otitis media (AOM) and in healthy infants attending day-care centers (DCC), two populations with high reported pneumococcal carriage. Young children are an important reservoir and major source of transmission of bacteria to the whole community and thus the preferred population to study nasopharyngeal (NP) carriage. Aim of the study The main aim of this study is to evaluate if changes in the conjugate anti-pneumococcal vaccination program in Belgium have an impact on the nasopharyngeal carriage of Pneumococcus in infants aged 6-30 months suffering from AOM or attending day-care, in order to guide future pneumococcal vaccine program decisions and vaccine development, and to feed AOM treatment guidelines in a PCV-program environment. The study will monitor overall pneumococcal carriage, the serotypes involved and the sensitivity of the isolated strains to antibiotics. In addition, the rhinopharyngeal carriage of other common nasopharyngeal colonizers associated with disease, in particular Haemophilus influenzae, will be studied in order to evaluate if changes in pneumococcal carriage impact on the carriage of those pathogens. In infants with AOM, the study will also monitor the clinical course of the AOM and a second nasopharyngeal sample will be taken in case of antibiotic treatment failure or AOM recurrence to identify any association with the carried pathogen.

Conditions

Streptococcus Pneumoniae; Nasopharyngeal Carriage

Keywords

nasopharyngeal carriage; Streptococcus pneumoniae; acute otitis media; day-care centers

Outcome Measures

Primary Outcomes (1)

• prevalence

  To detect significant prevalence change of Sp serotypes 19A or 6A carriage over the observation period (three years, 2016-2018) in each of both study populations (AOM or DCC infants).

  3 years

Study Arms (2)

AOM (acute otitis media)

OTHER

Infants (6-30 months of age) with acute otitis media

Other: Nasopharyngeal sampling with a swab

DCC (day-care centers)

OTHER

Healthy infants (6-30 months of age) attending day-care centers

Other: Nasopharyngeal sampling with a swab

Interventions

Nasopharyngeal sampling with a swab OTHER

AOM (acute otitis media); DCC (day-care centers)

Eligibility Criteria

• Age: 6 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent read and signed AND acute onset of AOM symptoms within the preceding 7 days AND otoscopic signs OR new onset otorrhea not due to otitis externa
• Informed consent read and signed AND residing in a day-care center with a minimum of 9 infants daily present

You may not qualify if:

• Having received antibiotics in the past 7 days AND/OR a severe associated pathology AND/OR infant already included in the same winter season AND/OR (for infants recruited in hospital) referral by GP or having received 3 or more antibiotic treatments in the past 3 months

Sponsors & Collaborators

• Pierre Van Damme: lead
• Centre Hospitalier Intercommunal Creteil: collaborator
• University of Bristol: collaborator
• University Ghent: collaborator
• Centre Hospitalier Universitaire UCLouvain Namur: collaborator

Study Sites (1)

University of Antwerp

Wilrijk, Antwerp, 2610, Belgium

Location

Related Publications (1)

• Van den Bosch E, Vermeulen H, Ekinci E, Paranthoen L, Van Heirstraeten L, Malhotra-Kumar S, Desmet S, Theeten H, Maertens K. Interplay between maternal Tdap and infant pneumococcal vaccination in shaping infant pneumococcal vaccine serotype carriage. J Infect Dis. 2025 Aug 30:jiaf458. doi: 10.1093/infdis/jiaf458. Online ahead of print.

  PMID: 40884828 DERIVED

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Heidi Theeten, Professor

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 5, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)