Streptococcus PneumoniaeNCT02888457
Carriage of Streptococcus Pneumoniae in Infants With Acute Otitis Media and in Infants Attending Day-care Centers
A study testing Nasopharyngeal sampling with a swab in people with Streptococcus Pneumoniae and Nasopharyngeal Carriage, run by Pierre Van Damme at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Pneumoniae, Nasopharyngeal Carriage
- What is being tested?
- Nasopharyngeal sampling with a swab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,817 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Nasopharyngeal Carriage of Streptococcus Pneumoniae (Sp) and Other Common Pathogens in Infants (6-30 Months of Age) With Acute Otitis Media and in Healthy Infants (6-30 Months of Age) Attending Day-care Centers
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).
Read more
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.
Read the detailed description
Study populations
Two infant populations with high (50 % and more) reported carriage of Sp were identified and will be approached for this study:
- Infants aged 6-30 months presenting with acute otitis media (according to specific clinical and otoscopic criteria) at their first line general physician or paediatrician and who have not recently received antibiotics and have no severe underlying disease (AOM infants).
- Healthy infants aged 6-30 months attending a day-care center and not recently having received antibiotics (DCC infants).
Investigator(s), study sites
75-87 paediatricians and general practitioners (GPs), and approximately 75 DCC throughout the whole of Belgium. Paediatricians in first line hospitals are allowed to participate.
The Primary objective
is 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).
Number of subjects
In the first year (2016), 700 and from the second year ( 2016-2017) onward 900, patients with AOM (between the ages of 6 and 30 months) will be included every year. The same number of healthy infants attending DCC will be included each year. Sample size was calculated to allow comparison between children recruited in the first winter season, who have received PCV13 for all or the majority of their pneumococcal vaccinations, and the children in the following seasons, who will have received PCV10 for the majority or all of their pneumococcal vaccinations. Some over-recruitment will be done during the first winter (2016) of infants vaccinated in the region that has not yet changed from PCV13 to PCV10, since these infants will have received PCV13 for their 12 months booster too. The proposed sample size allows to detect changes as low as 3 % for 19A and 6A combined, and 4 % for each of them separately with 80 % power, in each of the AOM and day-care infant groups.
Period of observation
Since Sp carriage as well as AOM are most prevalent in and around the winter season, recruitment will be scheduled focusing on this period. In 2016, recruitment of infants presenting with AOM is foreseen from January till end of May, but can be extended to June if necessary to achieve the target number. Thereafter, infants with AOM will be recruited every year from October till end of May (starting October 2016). For healthy infants attending DCC recruitment is planned to start in March 2016, and thereafter every season from October 1st till May 31st. The current protocol covers the first observation period, from 2016 to 2018 covering 3 winter seasons.
- Conditions
- Streptococcus Pneumoniae, Nasopharyngeal Carriage
- Being tested
- Nasopharyngeal sampling with a swab
- Keywords
- nasopharyngeal carriage, Streptococcus pneumoniae, acute otitis media, day-care centers
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal sampling with a swabOther
| Study group | Role | What they receive |
|---|---|---|
| AOM (acute otitis media) | Other | Infants (6-30 months of age) with acute otitis media Receives: Other: Nasopharyngeal sampling with a swab |
| DCC (day-care centers) | Other | Healthy infants (6-30 months of age) attending day-care centers Receives: Other: Nasopharyngeal sampling with a swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Streptococcus PneumoniaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Van Damme
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Creteil, University of Bristol, University Ghent, Centre Hospitalier Universitaire UCLouvain Namur
- Responsible party
- Sponsor-investigator, Pierre Van Damme, Universiteit Antwerpen
- Investigators
- Heidi Theeten, Professor, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888457
- Sponsor's protocol ID
- 15/45/471
- Status last verified
- Nov 2020
- First submitted
- 30 Aug 2016
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Van den Bosch E, Vermeulen H, Ekinci E, Paranthoen L, Van Heirstraeten L, Malhotra-Kumar S, Desmet S, Theeten H, Maertens K. Interplay between Tetanus, Diphtheria, Acellular Pertussis Vaccination in Pregnancy and Infant Pneumococcal Vaccination in Shaping Infant Pneumococcal Vaccine Serotype Carriage. J Infect Dis. 2026 Feb 18;233(2):298-306. doi: 10.1093/infdis/jiaf458.
PubMed 40884828
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Nasopharyngeal Carriage of Streptococcus Pneumoniae (Sp) and Other Common Pathogens in Infants (6-30 Months of Age) With Acute Otitis Media and in Healthy Infants (6-30 Months of Age) Attending Day-care Centers
- ClinicalTrials.gov ID
- NCT02888457
- Acronym / sponsor ID
- 15/45/471
- Conditions
- Streptococcus Pneumoniae, Nasopharyngeal Carriage
- Keywords
- nasopharyngeal carriage, Streptococcus pneumoniae, acute otitis media, day-care centers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,817 participants (actual)
- Lead sponsor
- Pierre Van DammeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal Creteil, University of Bristol, University Ghent, Centre Hospitalier Universitaire UCLouvain Namur
- Study start
- Oct 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study populations
Two infant populations with high (50 % and more) reported carriage of Sp were identified and will be approached for this study:
- Infants aged 6-30 months presenting with acute otitis media (according to specific clinical and otoscopic criteria) at their first line general physician or paediatrician and who have not recently received antibiotics and have no severe underlying disease (AOM infants).
- Healthy infants aged 6-30 months attending a day-care center and not recently having received antibiotics (DCC infants).
Investigator(s), study sites
75-87 paediatricians and general practitioners (GPs), and approximately 75 DCC throughout the whole of Belgium. Paediatricians in first line hospitals are allowed to participate.
The Primary objective
is 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).
Number of subjects
In the first year (2016), 700 and from the second year ( 2016-2017) onward 900, patients with AOM (between the ages of 6 and 30 months) will be included every year. The same number of healthy infants attending DCC will be included each year. Sample size was calculated to allow comparison between children recruited in the first winter season, who have received PCV13 for all or the majority of their pneumococcal vaccinations, and the children in the following seasons, who will have received PCV10 for the majority or all of their pneumococcal vaccinations. Some over-recruitment will be done during the first winter (2016) of infants vaccinated in the region that has not yet changed from PCV13 to PCV10, since these infants will have received PCV13 for their 12 months booster too. The proposed sample size allows to detect changes as low as 3 % for 19A and 6A combined, and 4 % for each of them separately with 80 % power, in each of the AOM and day-care infant groups.
Period of observation
Since Sp carriage as well as AOM are most prevalent in and around the winter season, recruitment will be scheduled focusing on this period. In 2016, recruitment of infants presenting with AOM is foreseen from January till end of May, but can be extended to June if necessary to achieve the target number. Thereafter, infants with AOM will be recruited every year from October till end of May (starting October 2016). For healthy infants attending DCC recruitment is planned to start in March 2016, and thereafter every season from October 1st till May 31st. The current protocol covers the first observation period, from 2016 to 2018 covering 3 winter seasons.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOM (acute otitis media) | Other | Other: Nasopharyngeal sampling with a swabInfants (6-30 months of age) with acute otitis media |
| DCC (day-care centers) | Other | Other: Nasopharyngeal sampling with a swabHealthy infants (6-30 months of age) attending day-care centers |
Who may qualify
- Ages
- 6 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal sampling with a swab | Other | AOM (acute otitis media), DCC (day-care centers) |
Primary outcome
prevalence
Time frame: 3 years
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Derived from this study: PubMed 40884828Van den Bosch E, Vermeulen H, Ekinci E, Paranthoen L, Van Heirstraeten L, Malhotra-Kumar S, Desmet S, Theeten H, Maertens K. Interplay between Tetanus, Diphtheria, Acellular Pertussis Vaccination in Pregnancy and Infant Pneumococcal Vaccination in Shaping Infant Pneumococcal Vaccine Serotype Carriage. J Infect Dis. 2026 Feb 18;233(2):298-306. doi: 10.1093/infdis/jiaf458.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Theeten, Professor principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal sampling with a swab in people with Streptococcus Pneumoniae and Nasopharyngeal Carriage, run by Pierre Van Damme at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02888457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.