OtorrheaNCT04807660
Bacteriological Evaluation of Children With Otorrhea
An observational study of Otorrhea, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
Trial summary
After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). Read more about this study
- Who is it for?
- Ages 3 months to 15 years
- Conditions the study is for
- Otorrhea
- What is being tested?
- middle ear fluid sample for bacterial analysis (conventional microbiology analysis)
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2015to 31 Oct 2028
- Phase
- Observational
- 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 3 months to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: all children from 3 months to 15 years old with otorrhea
Who may be able to join
- children from 3 months to 15 years old
- with otorrhea
- signed parents consent
Who cannot join
- children under 3 months
- children > 15 years old
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, 94000
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: Bacteriological Evaluation of Spontaneous Otorrhea in Children
After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.
Read the detailed description
Since October 2015, children with spontaneous perforation of the tympanic membrane (SPTM) are prospectively enrolled by 20 pediatricians who are part of a research and teaching network (ACTIV, Association Clinique et Thérapeutique Infantile du Val de Marne [Clinical and Therapeutic Association of Val de Marne]) throughout France. For some patients, otorrhea is the first manifestation of AOM; for others, otorrhea occurred after AOM treatment failure or recurrence. Failure (non-responsive AOM) is defined as otorrhea appearing despite at least 48 hr of antibiotics or recurring less than 4 days after the end of antibiotic treatment. Recurrence is defined by the appearance of otorrhea 4 to 30 days after the end of antibiotic treatment for AOM.
Middle ear fluid (MEF) is obtained by sampling spontaneous discharge according to clinical practice guidelines. MEF specimens are obtained with cotton-tipped wire swabs, immediately placed in transport medium (Copan Venturi Transystem®, Brescia, Italy), and transported within 48 hr to one of the two centralized microbiology laboratories (Robert Debré Hospital or National Centre for Pneumococci at European Georges Pompidou Hospital, Paris, France).
- Conditions
- Otorrhea
- Being tested
- middle ear fluid sample for bacterial analysis (conventional microbiology analysis)
- Keywords
- otorrhea, children, spontaneous perforation of the tympanic membrane, ambulatory, streptococcus pneumoniae, heamophilus influenzae, moraxella catarrhalis, streptococcus pyogenes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
middle ear fluid sample for bacterial analysis (conventional microbiology analysis)Other
Also called middle ear fluid sample for molecular sequencing analysis, middle ear fluid sample for Rapid Diagnostic Test (RDT)
A middle ear fluid sample will be collected from each enrolled child for the third analysis procedure.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Middle ear fluid sample for each enrrolled children Receives: Other: middle ear fluid sample for bacterial analysis (conventional microbiology analysis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological Profiles of Spontaneous Otorrhea in Children
To determine the microbiological profiles of spontaneous otorrhea in children by identifying the bacterial pathogens present in collected samples.
Measured: at inclusion
Secondary outcomes (4)
Descriptive analysis of patient characteristics according to bacteriological Profiles
To describe, for each bacterial species identified, patient characteristics according to demographics, vaccinal and general medical history, AOM history, and sample collection conditions.
Measured: at inclusion
Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM
To describe the clinical characteristics of treatment failure or recurrence in children with acute otitis media (AOM), according to the identified bacteria, including symptom severity, duration, and observed clinical signs.
Measured: at inclusion
Microbiota Analysis of Spontaneous Otorrhea in Children
To analyze the microbiota involved in spontaneous otorrhea and bacterial interactions using molecular biology techniques and compare these results with conventional bacteriological methods.
Measured: at inclusion
Comparison Between Rapid Diagnostic Test (RDT) and Laboratory Results
To compare the results of the rapid diagnostic test (RDT) with those obtained from samples analyzed in the laboratory using standard bacteriological methods.
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 posted19 Mar 2021
- Study start1 Oct 2015
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OtorrheaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Cohen, Study director, Association Clinique et Thérapeutique Infantile du Val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807660
- Sponsor's protocol ID
- ACT0315
- Status last verified
- Oct 2026
- First submitted
- 18 Mar 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Levy C, Varon E, Ouldali N, Wollner A, Thollot F, Corrard F, Werner A, Bechet S, Bonacorsi S, Cohen R. Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine. PLoS One. 2019 Feb 1;14(2):e0211712. doi: 10.1371/journal.pone.0211712. eCollection 2019.
PubMed 30707730Assad 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.
PubMed 37998807Levy C, Varon E, Bidet P, Bechet S, Batard C, Wollner A, Thollot F, Bonacorsi S, Cohen R. Otorrhea bacterial profile, epidemiology before widespread use of the third-generation pneumococcal conjugate vaccine in French children, a prospective study from 2015 to 2023. Infect Dis Now. 2023 Sep;53(6):104738. doi: 10.1016/j.idnow.2023.104738. Epub 2023 Jun 17.
PubMed 37331698Cohen R, Varon E, Bidet P, Cohen JF, Bechet S, Couloigner V, Michot AS, Guiheneuf C, Bonacorsi S, Levy C. Diagnostic Accuracy of Group A Streptococcus Rapid Antigen Detection Test on Middle Ear Fluid in Children With Acute Otitis Media With Spontaneous Perforation: A Prospective Multicenter Evaluation. Pediatr Infect Dis J. 2023 Sep 1;42(9):816-818. doi: 10.1097/INF.0000000000004009. Epub 2023 Jun 22.
PubMed 37368992
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriological Evaluation of Spontaneous Otorrhea in Children
- ClinicalTrials.gov ID
- NCT04807660
- Acronym / sponsor ID
- ACT0315
- Conditions
- Otorrhea
- Keywords
- otorrhea, children, spontaneous perforation of the tympanic membrane, ambulatory, streptococcus pneumoniae, heamophilus influenzae, moraxella catarrhalis, streptococcus pyogenes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 19 Mar 2021 (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.
After pneumococcal conjugate vaccine implementation, the number of acute otitis media (AOM) episodes has decreased, but AOM still remains among the most common diagnoses in childhood. From 2% to 17% of cases of AOM feature spontaneous perforation of the tympanic membrane (SPTM). The aim of this study was to describe the bacteriological causes of SPTM several years after PCV13 implementation, in 2010.
Detailed description
Since October 2015, children with spontaneous perforation of the tympanic membrane (SPTM) are prospectively enrolled by 20 pediatricians who are part of a research and teaching network (ACTIV, Association Clinique et Thérapeutique Infantile du Val de Marne [Clinical and Therapeutic Association of Val de Marne]) throughout France. For some patients, otorrhea is the first manifestation of AOM; for others, otorrhea occurred after AOM treatment failure or recurrence. Failure (non-responsive AOM) is defined as otorrhea appearing despite at least 48 hr of antibiotics or recurring less than 4 days after the end of antibiotic treatment. Recurrence is defined by the appearance of otorrhea 4 to 30 days after the end of antibiotic treatment for AOM.
Middle ear fluid (MEF) is obtained by sampling spontaneous discharge according to clinical practice guidelines. MEF specimens are obtained with cotton-tipped wire swabs, immediately placed in transport medium (Copan Venturi Transystem®, Brescia, Italy), and transported within 48 hr to one of the two centralized microbiology laboratories (Robert Debré Hospital or National Centre for Pneumococci at European Georges Pompidou Hospital, Paris, France).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Other: middle ear fluid sample for bacterial analysis (conventional microbiology analysis)Middle ear fluid sample for each enrrolled children |
Who may qualify
- Ages
- 3 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- all children from 3 months to 15 years old with otorrhea
Key inclusion criteria (3 listed)
- children from 3 months to 15 years old
- with otorrhea
- signed parents consent
Key exclusion criteria (2 listed)
- children under 3 months
- children > 15 years old
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 |
|---|---|---|
| middle ear fluid sample for bacterial analysis (conventional microbiology analysis)Also: middle ear fluid sample for molecular sequencing analysis, middle ear fluid sample for Rapid Diagnostic Test (RDT)A middle ear fluid sample will be collected from each enrolled child for the third analysis procedure. | Other | Prospective cohort |
Primary outcome
Microbiological Profiles of Spontaneous Otorrhea in Children
Time frame: at inclusion
To determine the microbiological profiles of spontaneous otorrhea in children by identifying the bacterial pathogens present in collected samples.
4 secondary outcomes
Descriptive analysis of patient characteristics according to bacteriological Profiles
Time frame: at inclusion
Clinical Characteristics of Treatment Failure or Recurrence in Children with AOM
Time frame: at inclusion
Microbiota Analysis of Spontaneous Otorrhea in Children
Time frame: at inclusion
Comparison Between Rapid Diagnostic Test (RDT) and Laboratory Results
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 29 Oct 2026.
- Background: PubMed 30707730Levy C, Varon E, Ouldali N, Wollner A, Thollot F, Corrard F, Werner A, Bechet S, Bonacorsi S, Cohen R. Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccine. PLoS One. 2019 Feb 1;14(2):e0211712. doi: 10.1371/journal.pone.0211712. eCollection 2019.
- Results publication: PubMed 37998807Assad 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.
- Results publication: PubMed 37331698Levy C, Varon E, Bidet P, Bechet S, Batard C, Wollner A, Thollot F, Bonacorsi S, Cohen R. Otorrhea bacterial profile, epidemiology before widespread use of the third-generation pneumococcal conjugate vaccine in French children, a prospective study from 2015 to 2023. Infect Dis Now. 2023 Sep;53(6):104738. doi: 10.1016/j.idnow.2023.104738. Epub 2023 Jun 17.
- Results publication: PubMed 37368992Cohen R, Varon E, Bidet P, Cohen JF, Bechet S, Couloigner V, Michot AS, Guiheneuf C, Bonacorsi S, Levy C. Diagnostic Accuracy of Group A Streptococcus Rapid Antigen Detection Test on Middle Ear Fluid in Children With Acute Otitis Media With Spontaneous Perforation: A Prospective Multicenter Evaluation. Pediatr Infect Dis J. 2023 Sep 1;42(9):816-818. doi: 10.1097/INF.0000000000004009. Epub 2023 Jun 22.
- Bacterial causes of otitis media with spontaneous perforation of the tympanic membrane in the era of 13 valent pneumococcal conjugate vaccineLink provided by the sponsor.
- Antibiotic Resistance of Haemophilus influenzae in Nasopharyngeal Carriage of Children with Acute Otitis Media and in Middle Ear Fluid from OtorrheaLink provided by the sponsor.
- Otorrhea bacterial profile, epidemiology before widespread use of the third-generation pneumococcal conjugate vaccine in French children, a prospective study from 2015 to 2023Link provided by the sponsor.
- Diagnostic Accuracy of Group A Streptococcus Rapid Antigen Detection Test on Middle Ear Fluid in Children With Acute Otitis Media With Spontaneous Perforation: A Prospective Multicenter EvaluationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 study director
Association Clinique et 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?
An observational study of Otorrhea, 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 3 inclusion and 2 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 29 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?
Microbiological Profiles of Spontaneous Otorrhea in Children (time frame: at inclusion). 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 NCT04807660, which also lists 4 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 29 Oct 2026.