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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
Since September 2001, 54 pediatricians who are part of a research and teaching network (ACTIV) throughout France participated at this prospective study. From October to June of each subsequent year, children of both sexes suffering from suppurative acute otitis media (AOM) with fever and/or otalgia (in order to increase the probability of pneumococcal AOM), aged 6 to 36 months, were enrolled. And a second group of healthy children aged 6 months to 15 years were also enrolled for the main study.
For ancillary study a subgroup of AOM children were enrolled for assessment of E. coli (ESBL) resistance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prospective cohort: Main study | Other | 700 children aged 6 to 36 months with AOM and 500 healthy control children aged 6 months to 15 years will be enrolled. A mandatory nasopharyngeal swab is planned for these groups. |
|
| ESBL cohort- Ancillary study | Other | For a subgroup of approximately 500 children with AOM, aged 6 to 24 months, optional stool or anorectal swab samples will be collected. |
|
| Optional Nasopharyngeal sample | Other | For a subgroup of 560 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) with different pneumococcal serotypes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nasopharyngeal sample (mandatory) | Other | A mandatory nasopharyngeal swab is planned for each included patient: patients aged 6 to 36 months with AOM and control children (healthy) aged 6 months to 15 years. The bacteriological analyses will be carried out by the French National Reference Centre for Pneumococci. |
| Measure | Description | Time Frame |
|---|---|---|
| S. Pneumoniae colonisation | Percentage of children colonised by S. Pneumoniae | at inclusion |
| S. Pneumoniae colonisation involving to vaccine serotypes | Percentage of children colonised by vaccine serotypes | at inclusion |
| S. Pneumoniae colonisation involving to non vaccine serotypes | Percentage of children colonised by non vaccine serotypes | at inclusion |
| Reduced of sensitivity to penicillin | Percentage of Sp carriers with reduced sensitivity to penicillin | at inclusion |
| Detect the emergence of new serotypes | Percentage of emerging serotypes detected (> 10 Percent of isolated Sp, 5 percent of carrier children) | 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) in children with AOM. | at inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Detect the emergence of resistance S. pneumoniae | Percentage of penicillin resistant S. pneumoniae | 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. |
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children seen on an outpatient
Inclusion Criteria:
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,
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Corinne Levy, MD | Contact | 0033148850404 | corinne.levy@activ-france.fr | |
| Stéphane Béchet, MsC | Contact | 0033148850404 | stephane.bechet@activ-france.fr |
| Name | Affiliation | Role |
|---|---|---|
| Robert Cohen, MD | Association Clinique Thérapeutique Infantile du val de Marne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACTIV | Recruiting | Créteil | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39841925 | Background | Levy C, Varon E, Bechet S, Bonacorsi S, Cohen R. Similarities and Differences Between Countries When Estimating the Effect of Higher-valency Pneumococcal Conjugate Vaccines on Colonization and Acute Otitis Media. Pediatr Infect Dis J. 2025 May 1;44(5):e184-e186. doi: 10.1097/INF.0000000000004686. Epub 2025 Jan 21. No abstract available. | |
| 31280295 |
| Label | URL |
|---|---|
| ACTIV publications | View source |
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multicenter nationwide prospective cohort
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|
| Stools collection or anorectal swab samples (optional) | Other | For a subgroup of AOM children aged 6 to 36 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 6 to 36 months to assess the association of various respiratory viruses (SARS-CoV-2, RSV, Influenza A, Influenza B) with different pneumococcal serotypes. |
|
| at inclusion |
| For the ancillary study, the resistance of E. coli (ESBL) will be evaluated. | Assessment of E. coli (ESBL) resistance. | at inclusion |
| 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. |
| 29227464 | Result | Rybak 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. |
| 28418829 | Result | Birgy 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. |
| 26271823 | Result | Cohen 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. |
| 21501471 | Result | Cohen 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. |
| 22397629 | Result | Cohen 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. |
| 29637893 | Result | Levy 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. |
| 30634919 | Result | Vermee 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. |
| 31617912 | Result | Birgy 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. |
| 25037572 | Result | Mizrahi 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. |
| 27330068 | Result | Birgy 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. |
| 23963858 | Result | Hau 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. |
| 23171127 | Result | Birgy 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. |
| 24263220 | Result | Caeymaex 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. |
| 22330166 | Result | Cohen 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. |
| 22925540 | Result | Cohen R, Levy C, Bingen E, Bechet S, Derkx V, Werner A, Koskas M, Varon E. [Nasopharyngeal carriage of children 6 to 60 months during the implementation of the 13-valent pneumococcal conjugate vaccine]. Arch Pediatr. 2012 Oct;19(10):1132-9. doi: 10.1016/j.arcped.2012.07.013. Epub 2012 Aug 24. French. |
| 18190319 | Result | Cohen R, Levy C, Thollot F, de La Rocque F, Koskas M, Bonnet E, Fritzell B, Varon E. Pneumococcal conjugate vaccine does not influence Staphylococcus aureus carriage in young children with acute otitis media. Clin Infect Dis. 2007 Dec 15;45(12):1583-7. doi: 10.1086/523734. |
| 17072121 | Result | Cohen R, Levy C, de La Rocque F, Gelbert N, Wollner A, Fritzell B, Bonnet E, Tetelboum R, Varon E. Impact of pneumococcal conjugate vaccine and of reduction of antibiotic use on nasopharyngeal carriage of nonsusceptible pneumococci in children with acute otitis media. Pediatr Infect Dis J. 2006 Nov;25(11):1001-7. doi: 10.1097/01.inf.0000243163.85163.a8. |
| 37998807 | Result | Assad Z, Cohen R, Varon E, Levy C, Bechet S, Corrard F, Werner A, Ouldali N, Bonacorsi S, Rybak A. Antibiotic Resistance of Haemophilus influenzae in Nasopharyngeal Carriage of Children with Acute Otitis Media and in Middle Ear Fluid from Otorrhea. Antibiotics (Basel). 2023 Nov 8;12(11):1605. doi: 10.3390/antibiotics12111605. |
| Similarities and Differences Between Countries When Estimating the Effect of Higher-valency Pneumococcal Conjugate Vaccines on Colonization and Acute Otitis Media | View source |