Nasopharyngeal CarriageNCT04460313
Nasopharyngeal Carriage of S. Pneumoniae
A study testing nasopharyngeal sample (mandatory), Stools collection or anorectal swab samples (optional) and nasopharyngeal sample (optional) in people with Nasopharyngeal Carriage and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a… Read more about this study
- Who is it for?
- Ages 4 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carriage, Children, Only, Antibiotic Resistant Strain
- What is being tested?
- nasopharyngeal sample (mandatory), Stools collection or anorectal swab samples (optional) and nasopharyngeal sample (optional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29,360 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2001to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- both sexes
- suffering from suppurative AOM or healthy children
- age: 4 months to 36 months for AOM
- age: 4 months to 15 years for healthy children
- informed consent from parents or guardians
- Children who haven't received antibiotic treatment within 7 days before enrollment,
- Children with bullous myringitis cannot be included.
Who cannot join
- severe underlying disease,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ACTIV
Créteil
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children"
This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.
Read the detailed description
Since September 2001, 66 pediatricians from the ACTIV research and teaching network throughout France participate in this prospective study. Each year from October to June, children of both sexes aged 4 to 36 months, presenting with suppurative acute otitis media (AOM) accompanied by fever and/or otalgia (to increase the probability of pneumococcal AOM), are enrolled. Within this cohort, patients are offered an additional, optional nasal swab for a rapid viral diagnostic test (targeting SARS-CoV-2, RSV, Influenza A, Influenza B, and hMPV).
Additionally, another group of healthy children aged 4 months to 15 years is also enrolled for the main study.
For the ancillary study, a subgroup of children with AOM (aged 6 to 24 months) is enrolled for the assessment of ESBL-producing E. coli resistance.
- Being tested
- nasopharyngeal sample (mandatory), Stools collection or anorectal swab samples (optional), nasopharyngeal sample (optional)
- Keywords
- Pneumococcal conjugate vaccine, Streptococcus pneumoniae, Carriage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal sample (mandatory)Other
A mandatory nasopharyngeal swab is planned for each included patient: patients aged 4 to 36 months with AOM and control children (healthy) aged 4 months to 15 years. The bacteriological analyses will be carried out by the French National Reference Centre for Pneumococci.
Stools collection or anorectal swab samples (optional)Other
For a subgroup of AOM children aged 6 to 24 months, stools samples or anorectal swab samples were collected for assessment of E. coli (ESBL) resistance
nasopharyngeal sample (optional)Other
Optional nasopharyngeal swabs from children with AOM aged 4 to 36 months to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B, hMPV) with different pneumococcal serotypes.
| Study group | Role | What they receive |
|---|---|---|
| prospective cohort: Main study | Other | 2100 children aged 4 to 36 months with AOM and 1500 healthy control children aged 4 months to 15 years will be enrolled. A mandatory nasopharyngeal swab is planned for these groups. Receives: Other: nasopharyngeal sample (mandatory) |
| ESBL cohort- Ancillary study | Other | For a subgroup of approximately 1500 children with AOM, aged 6 to 24 months, optional stool or anorectal swab samples will be collected. Receives: Other: nasopharyngeal sample (mandatory); Other: Stools collection or anorectal swab samples (optional); Other: nasopharyngeal sample (optional) |
| Optional Nasopharyngeal sample | Other | For a subgroup of 1680 children with AOM, an optional nasal sample will be collected to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B, hMPV) with different pneumococcal serotypes. Receives: Other: nasopharyngeal sample (mandatory); Other: nasopharyngeal sample (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
S. Pneumoniae colonisation
Percentage of children colonised by S. Pneumoniae
Measured: at inclusion
S. Pneumoniae colonisation involving to vaccine serotypes
Percentage of children colonised by vaccine serotypes
Measured: at inclusion
S. Pneumoniae colonisation involving to non vaccine serotypes
Percentage of children colonised by non vaccine serotypes
Measured: at inclusion
Reduced of sensitivity to penicillin
Percentage of Sp carriers with reduced sensitivity to penicillin
Measured: at inclusion
Detect the emergence of new serotypes
Percentage of emerging serotypes detected (> 10 Percent of isolated Sp, 5 percent of carrier children)
Measured: at inclusion
Association of Pneumococcal Serotypes with Respiratory Viruses
Percentage of pneumococcal serotypes associated with various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B, hMPV) in children with AOM.
Measured: at inclusion
Secondary outcomes (3)
Detect the emergence of resistance S. pneumoniae
Percentage of penicillin resistant S. pneumoniae
Measured: at inclusion
Evaluation of nasopharyngeal carriage of other bacteria
Assessment of carriage of Haemophilus influenzae, Moraxella Catarrhalis, Staphylococcus aureus and group A Streptococcus in AOM group and in healthy children group.
Measured: at inclusion
For the ancillary study, the resistance of E. coli (ESBL) will be evaluated.
Assessment of E. coli (ESBL) resistance.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start11 Sep 2001
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal CarriageStudies 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
- Single group
- Model description
- multicenter nationwide prospective cohort
- Masking
- None (open label)
- Enrolment
- 29,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Robert Cohen, MD, Principal investigator, Association Clinique Thérapeutique Infantile du val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460313
- Sponsor's protocol ID
- ACT0806
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ouldali N, Cohen R, Levy C, Gelbert-Baudino N, Seror E, Corrard F, Vie Le Sage F, Michot AS, Romain O, Bechet S, Bonacorsi S, Angoulvant F, Varon E. Pneumococcal susceptibility to antibiotics in carriage: a 17 year time series analysis of the adaptive evolution of non-vaccine emerging serotypes to a new selective pressure environment. J Antimicrob Chemother. 2019 Oct 1;74(10):3077-3086. doi: 10.1093/jac/dkz281.
PubMed 31280295Rybak A, Levy C, Bonacorsi S, Bechet S, Vie le Sage F, Elbez A, Varon E, Cohen R. Antibiotic Resistance of Potential Otopathogens Isolated From Nasopharyngeal Flora of Children With Acute Otitis Media Before, During and After Pneumococcal Conjugate Vaccines Implementation. Pediatr Infect Dis J. 2018 Mar;37(3):e72-e78. doi: 10.1097/INF.0000000000001862.
PubMed 29227464Birgy A, Bidet P, Levy C, Sobral E, Cohen R, Bonacorsi S. CTX-M-27-Producing Escherichia coli of Sequence Type 131 and Clade C1-M27, France. Emerg Infect Dis. 2017 May;23(5):885. doi: 10.3201/eid2305.161865. No abstract available.
PubMed 28418829Cohen R, Varon E, Doit C, Schlemmer C, Romain O, Thollot F, Bechet S, Bonacorsi S, Levy C. A 13-year survey of pneumococcal nasopharyngeal carriage in children with acute otitis media following PCV7 and PCV13 implementation. Vaccine. 2015 Sep 22;33(39):5118-26. doi: 10.1016/j.vaccine.2015.08.010. Epub 2015 Aug 11.
PubMed 26271823Cohen R, Levy C, Bonnet E, Thollot F, Boucherat M, Fritzell B, Derkx V, Bingen E, Varon E. Risk factors for serotype 19A carriage after introduction of 7-valent pneumococcal vaccination. BMC Infect Dis. 2011 Apr 18;11:95. doi: 10.1186/1471-2334-11-95.
PubMed 21501471Cohen R, Bingen E, Levy C, Thollot F, Boucherat M, Derkx V, Varon E. Nasopharyngeal flora in children with acute otitis media before and after implementation of 7 valent pneumococcal conjugate vaccine in France. BMC Infect Dis. 2012 Mar 7;12:52. doi: 10.1186/1471-2334-12-52.
PubMed 22397629Levy C, Vie le Sage F, Varon E, Chalumeau M, Grimprel E, Cohen R. Pediatric Ambulatory and Hospital Networks for Surveillance and Clinical Epidemiology of Community-Acquired Infections. J Pediatr. 2018 Mar;194:269-270.e2. doi: 10.1016/j.jpeds.2017.11.050. Epub 2018 Feb 22. No abstract available.
PubMed 29637893Vermee Q, Cohen R, Hays C, Varon E, Bonacorsi S, Bechet S, Thollot F, Corrard F, Poyart C, Levy C, Raymond J. Biofilm production by Haemophilus influenzae and Streptococcus pneumoniae isolated from the nasopharynx of children with acute otitis media. BMC Infect Dis. 2019 Jan 11;19(1):44. doi: 10.1186/s12879-018-3657-9.
PubMed 30634919Birgy A, Madhi F, Jung C, Levy C, Cointe A, Bidet P, Hobson CA, Bechet S, Sobral E, Vuthien H, Ferroni A, Aberrane S, Cuzon G, Beraud L, Gajdos V, Launay E, Pinquier D, Haas H, Desmarest M, Dommergues MA, Cohen R, Bonacorsi S; Group of the National Observatory of Urinary tract Infection due to ESBL-producing Enterobacteriaceae in children. Diversity and trends in population structure of ESBL-producing Enterobacteriaceae in febrile urinary tract infections in children in France from 2014 to 2017. J Antimicrob Chemother. 2020 Jan 1;75(1):96-105. doi: 10.1093/jac/dkz423.
PubMed 31617912Mizrahi A, Cohen R, Varon E, Bonacorsi S, Bechet S, Poyart C, Levy C, Raymond J. Non typable-Haemophilus influenzae biofilm formation and acute otitis media. BMC Infect Dis. 2014 Jul 19;14:400. doi: 10.1186/1471-2334-14-400.
PubMed 25037572Birgy A, Levy C, Bidet P, Thollot F, Derkx V, Bechet S, Mariani-Kurkdjian P, Cohen R, Bonacorsi S. ESBL-producing Escherichia coli ST131 versus non-ST131: evolution and risk factors of carriage among French children in the community between 2010 and 2015. J Antimicrob Chemother. 2016 Oct;71(10):2949-56. doi: 10.1093/jac/dkw219. Epub 2016 Jun 20.
PubMed 27330068Hau I, Levy C, Caeymaex L, Cohen R. Impact of pneumococcal conjugate vaccines on microbial epidemiology and clinical outcomes of acute otitis media. Paediatr Drugs. 2014 Feb;16(1):1-12. doi: 10.1007/s40272-013-0044-2.
PubMed 23963858Birgy A, Cohen R, Levy C, Bidet P, Courroux C, Benani M, Thollot F, Bingen E. Community faecal carriage of extended-spectrum beta-lactamase-producing Enterobacteriaceae in French children. BMC Infect Dis. 2012 Nov 21;12:315. doi: 10.1186/1471-2334-12-315.
PubMed 23171127Caeymaex L, Varon E, Levy C, Bechet S, Derkx V, Desvignes V, Doit C, Cohen R. Characteristics and outcomes of acute otitis media in children carrying streptococcus pneumoniae or haemophilus influenzae in their nasopharynx as a single otopathogen after introduction of the heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 May;33(5):533-6. doi: 10.1097/INF.0000000000000213.
PubMed 24263220Cohen R, Levy C, Bingen E, Koskas M, Nave I, Varon E. Impact of 13-valent pneumococcal conjugate vaccine on pneumococcal nasopharyngeal carriage in children with acute otitis media. Pediatr Infect Dis J. 2012 Mar;31(3):297-301. doi: 10.1097/INF.0b013e318247ef84.
PubMed 22330166
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children"
- ClinicalTrials.gov ID
- NCT04460313
- Acronym / sponsor ID
- ACT0806
- Keywords
- Pneumococcal conjugate vaccine, Streptococcus pneumoniae, Carriage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29,360 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 11 Sep 2001 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Jul 2020 (actual)
- 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.
This nasopharyngeal (NP) carriage surveillance study was requested by the European Agency for the Evaluation of Medicinal Products as a post-licensing commitment to determine whether the use of the pneumococcal conjugate vaccines (PCVs) including 7 then 13 valents (introduced in 2001 and 2010, respectively) caused a shift in the distribution of Streptococcus pneumoniae serotypes in children with acute otitis media and modified the resistance of this bacterial species to antibiotics.
Detailed description
Since September 2001, 66 pediatricians from the ACTIV research and teaching network throughout France participate in this prospective study. Each year from October to June, children of both sexes aged 4 to 36 months, presenting with suppurative acute otitis media (AOM) accompanied by fever and/or otalgia (to increase the probability of pneumococcal AOM), are enrolled. Within this cohort, patients are offered an additional, optional nasal swab for a rapid viral diagnostic test (targeting SARS-CoV-2, RSV, Influenza A, Influenza B, and hMPV).
Additionally, another group of healthy children aged 4 months to 15 years is also enrolled for the main study.
For the ancillary study, a subgroup of children with AOM (aged 6 to 24 months) is enrolled for the assessment of ESBL-producing E. coli resistance.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- multicenter nationwide prospective cohort
| Arm | Type | Receives |
|---|---|---|
| prospective cohort: Main study | Other | Other: nasopharyngeal sample (mandatory)2100 children aged 4 to 36 months with AOM and 1500 healthy control children aged 4 months to 15 years will be enrolled. A mandatory nasopharyngeal swab is planned for these groups. |
| ESBL cohort- Ancillary study | Other | Other: nasopharyngeal sample (mandatory), Other: Stools collection or anorectal swab samples (optional), Other: nasopharyngeal sample (optional)For a subgroup of approximately 1500 children with AOM, aged 6 to 24 months, optional stool or anorectal swab samples will be collected. |
| Optional Nasopharyngeal sample | Other | Other: nasopharyngeal sample (mandatory), Other: nasopharyngeal sample (optional)For a subgroup of 1680 children with AOM, an optional nasal sample will be collected to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B, hMPV) with different pneumococcal serotypes. |
Who may qualify
- Ages
- 4 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- both sexes
- suffering from suppurative AOM or healthy children
- informed consent from parents or guardians
- Children who haven't received antibiotic treatment within 7 days before enrollment,
- Children with bullous myringitis cannot be included.
Key exclusion criteria (1 listed)
- severe underlying disease,
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 sample (mandatory)A mandatory nasopharyngeal swab is planned for each included patient: patients aged 4 to 36 months with AOM and control children (healthy) aged 4 months to 15 years. The bacteriological analyses will be carried out by the French National Reference Centre for Pneumococci. | Other | ESBL cohort- Ancillary study, Optional Nasopharyngeal sample, prospective cohort: Main study |
| Stools collection or anorectal swab samples (optional)For a subgroup of AOM children aged 6 to 24 months, stools samples or anorectal swab samples were collected for assessment of E. coli (ESBL) resistance | Other | ESBL cohort- Ancillary study |
| nasopharyngeal sample (optional)Optional nasopharyngeal swabs from children with AOM aged 4 to 36 months to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B, hMPV) with different pneumococcal serotypes. | Other | ESBL cohort- Ancillary study, Optional Nasopharyngeal sample |
Primary outcome
S. Pneumoniae colonisation
Time frame: at inclusion
Percentage of children colonised by S. Pneumoniae
S. Pneumoniae colonisation involving to vaccine serotypes
Time frame: at inclusion
Percentage of children colonised by vaccine serotypes
S. Pneumoniae colonisation involving to non vaccine serotypes
Time frame: at inclusion
Percentage of children colonised by non vaccine serotypes
Reduced of sensitivity to penicillin
Time frame: at inclusion
Percentage of Sp carriers with reduced sensitivity to penicillin
Detect the emergence of new serotypes
Time frame: at inclusion
Percentage of emerging serotypes detected (> 10 Percent of isolated Sp, 5 percent of carrier children)
Association of Pneumococcal Serotypes with Respiratory Viruses
Time frame: at inclusion
Percentage of pneumococcal serotypes associated with various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B, hMPV) in children with AOM.
3 secondary outcomes
Detect the emergence of resistance S. pneumoniae
Time frame: at inclusion
Evaluation of nasopharyngeal carriage of other bacteria
Time frame: at inclusion
For the ancillary study, the resistance of E. coli (ESBL) will be evaluated.
Time frame: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Results publication: PubMed 31280295Ouldali N, Cohen R, Levy C, Gelbert-Baudino N, Seror E, Corrard F, Vie Le Sage F, Michot AS, Romain O, Bechet S, Bonacorsi S, Angoulvant F, Varon E. Pneumococcal susceptibility to antibiotics in carriage: a 17 year time series analysis of the adaptive evolution of non-vaccine emerging serotypes to a new selective pressure environment. J Antimicrob Chemother. 2019 Oct 1;74(10):3077-3086. doi: 10.1093/jac/dkz281.
- Results publication: PubMed 29227464Rybak A, Levy C, Bonacorsi S, Bechet S, Vie le Sage F, Elbez A, Varon E, Cohen R. Antibiotic Resistance of Potential Otopathogens Isolated From Nasopharyngeal Flora of Children With Acute Otitis Media Before, During and After Pneumococcal Conjugate Vaccines Implementation. Pediatr Infect Dis J. 2018 Mar;37(3):e72-e78. doi: 10.1097/INF.0000000000001862.
- Results publication: PubMed 28418829Birgy A, Bidet P, Levy C, Sobral E, Cohen R, Bonacorsi S. CTX-M-27-Producing Escherichia coli of Sequence Type 131 and Clade C1-M27, France. Emerg Infect Dis. 2017 May;23(5):885. doi: 10.3201/eid2305.161865. No abstract available.
- Results publication: PubMed 26271823Cohen R, Varon E, Doit C, Schlemmer C, Romain O, Thollot F, Bechet S, Bonacorsi S, Levy C. A 13-year survey of pneumococcal nasopharyngeal carriage in children with acute otitis media following PCV7 and PCV13 implementation. Vaccine. 2015 Sep 22;33(39):5118-26. doi: 10.1016/j.vaccine.2015.08.010. Epub 2015 Aug 11.
- Results publication: PubMed 21501471Cohen R, Levy C, Bonnet E, Thollot F, Boucherat M, Fritzell B, Derkx V, Bingen E, Varon E. Risk factors for serotype 19A carriage after introduction of 7-valent pneumococcal vaccination. BMC Infect Dis. 2011 Apr 18;11:95. doi: 10.1186/1471-2334-11-95.
- Results publication: PubMed 22397629Cohen R, Bingen E, Levy C, Thollot F, Boucherat M, Derkx V, Varon E. Nasopharyngeal flora in children with acute otitis media before and after implementation of 7 valent pneumococcal conjugate vaccine in France. BMC Infect Dis. 2012 Mar 7;12:52. doi: 10.1186/1471-2334-12-52.
- Results publication: PubMed 29637893Levy C, Vie le Sage F, Varon E, Chalumeau M, Grimprel E, Cohen R. Pediatric Ambulatory and Hospital Networks for Surveillance and Clinical Epidemiology of Community-Acquired Infections. J Pediatr. 2018 Mar;194:269-270.e2. doi: 10.1016/j.jpeds.2017.11.050. Epub 2018 Feb 22. No abstract available.
- Results publication: PubMed 30634919Vermee Q, Cohen R, Hays C, Varon E, Bonacorsi S, Bechet S, Thollot F, Corrard F, Poyart C, Levy C, Raymond J. Biofilm production by Haemophilus influenzae and Streptococcus pneumoniae isolated from the nasopharynx of children with acute otitis media. BMC Infect Dis. 2019 Jan 11;19(1):44. doi: 10.1186/s12879-018-3657-9.
- Results publication: PubMed 31617912Birgy A, Madhi F, Jung C, Levy C, Cointe A, Bidet P, Hobson CA, Bechet S, Sobral E, Vuthien H, Ferroni A, Aberrane S, Cuzon G, Beraud L, Gajdos V, Launay E, Pinquier D, Haas H, Desmarest M, Dommergues MA, Cohen R, Bonacorsi S; Group of the National Observatory of Urinary tract Infection due to ESBL-producing Enterobacteriaceae in children. Diversity and trends in population structure of ESBL-producing Enterobacteriaceae in febrile urinary tract infections in children in France from 2014 to 2017. J Antimicrob Chemother. 2020 Jan 1;75(1):96-105. doi: 10.1093/jac/dkz423.
- Results publication: PubMed 25037572Mizrahi A, Cohen R, Varon E, Bonacorsi S, Bechet S, Poyart C, Levy C, Raymond J. Non typable-Haemophilus influenzae biofilm formation and acute otitis media. BMC Infect Dis. 2014 Jul 19;14:400. doi: 10.1186/1471-2334-14-400.
- Results publication: PubMed 27330068Birgy A, Levy C, Bidet P, Thollot F, Derkx V, Bechet S, Mariani-Kurkdjian P, Cohen R, Bonacorsi S. ESBL-producing Escherichia coli ST131 versus non-ST131: evolution and risk factors of carriage among French children in the community between 2010 and 2015. J Antimicrob Chemother. 2016 Oct;71(10):2949-56. doi: 10.1093/jac/dkw219. Epub 2016 Jun 20.
- Results publication: PubMed 23963858Hau I, Levy C, Caeymaex L, Cohen R. Impact of pneumococcal conjugate vaccines on microbial epidemiology and clinical outcomes of acute otitis media. Paediatr Drugs. 2014 Feb;16(1):1-12. doi: 10.1007/s40272-013-0044-2.
- ACTIV publicationsLink provided by the sponsor.
- 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.
Robert Cohen, MD principal investigator
Association Clinique Thérapeutique Infantile du val de Marne
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 sample (mandatory), Stools collection or anorectal swab samples (optional) and nasopharyngeal sample (optional) in people with Nasopharyngeal Carriage and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
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 7 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy, MD (0033148850404, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
S. Pneumoniae colonisation (time frame: at inclusion). The study lists 6 primary outcomes in all. 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 NCT04460313, which also lists 22 linked publications.
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 27 Oct 2026.