---
title: Nasopharyngeal Carriage of S. Pneumoniae
nct_id: NCT04460313
overall_status: RECRUITING
phase: NA
sponsor: Association Clinique Thérapeutique Infantile du val de Marne
study_type: INTERVENTIONAL
primary_condition: Nasopharyngeal Carriage
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04460313.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04460313"
ct_last_update_post_date: 2026-03-19
last_seen_at: "2026-05-12T06:08:50.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Nasopharyngeal Carriage of S. Pneumoniae

**Official Title:** Observatory of Streptococcus Pneumoniae Nasopharyngeal Carriage in Infants With Acute Otitis Media (AOM) and in Healthy Children"

**NCT ID:** [NCT04460313](https://clinicaltrials.gov/study/NCT04460313)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 25760
- **Lead Sponsor:** Association Clinique Thérapeutique Infantile du val de Marne
- **Collaborators:** Pfizer
- **Conditions:** Nasopharyngeal Carriage, Children, Only, Antibiotic Resistant Strain
- **Start Date:** 2001-09-11
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2026-03-19

## Brief 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 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, 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.

## Eligibility

- **Minimum age:** 6 Months
- **Maximum age:** 15 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
children seen on an outpatient

Inclusion Criteria:

* both sexes
* suffering from suppurative AOM or healthy children

  * age: 6 months to 36 months for AOM
  * age: 6 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,

Exclusion Criteria:

* severe underlying disease,
* inclusion in the study during the previous 12 months
* Children with bullous myringitis cannot be included.
```

## Arms

- **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.

## Interventions

- **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.
- **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.

## Primary Outcomes

- **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) in children with AOM.

## 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)_

## Locations (1)

- ACTIV, Créteil, France — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.activ|créteil||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04460313.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04460313*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*