Deep Neck InfectionsNCT03644368
Children's Deep Neck Infections at the Montpellier Hospital
An observational study of Deep Neck Infections, run by University Hospital, Montpellier at 1 site in France.
Trial summary
To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Deep Neck Infections
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2018
- Phase
- Observational
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children hospitalized for acute pharyngeal infection
Who may be able to join
- under 18 years old
- hospitalized for acute pharyngeal infection ( cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses)
Who cannot join
- neck infection in the context of immune deficiency
- malignancy or post-traumatic disease
- others deep neck infections: angina, otitis, sinusitis, ethmoiditis, mastoiditis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Evaluation of the Management of Children's Deep Neck Infections at the Montpellier Hospital
To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. All children aged less than 18 years who had been admitted with a diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses between January 2015 and December 2017 were included. The investigators collected the demographic, biological, radiological data and treatment received of the patients to the admision. The results of the bacteriological samples were collected. The investigators compared our results to those of the 10-year cohort. The investigators wish to compare the duration of hospitalization and the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage
- Conditions
- Deep Neck Infections
- Keywords
- cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses, medical and chirurgical treatment, Bacteria in deep neck infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical description of acute peripharyngeal suppuration
Clinical description of acute peripharyngeal suppuration suppuration
Measured: 1 day
Secondary outcomes (2)
Description of therapeutic management
Description of therapeutic management : vaccinations, treatments received before hospitalization, treatments received during hospitalization
Measured: 1 day
Description of bacteria in deep neck infections
Description of bacteria in deep neck infections
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study startJan 2015
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Neck InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric JEZIORSKI, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644368
- Sponsor's protocol ID
- RECHMPL18_0212
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the Management of Children's Deep Neck Infections at the Montpellier Hospital
- ClinicalTrials.gov ID
- NCT03644368
- Acronym / sponsor ID
- RECHMPL18_0212
- Conditions
- Deep Neck Infections
- Keywords
- cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses, medical and chirurgical treatment, Bacteria in deep neck infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Aug 2018 (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.
To descride the clinical presentation, diagnosis, management and complications of children with a deep neck infection. A retrospective chart review was conducted at the Montpellier hospital in France. All children aged less than 18 years who had been admitted with a diagnosis of cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses between January 2015 and December 2017 were included. The investigators collected the demographic, biological, radiological data and treatment received of the patients to the admision. The results of the bacteriological samples were collected. The investigators compared our results to those of the 10-year cohort. The investigators wish to compare the duration of hospitalization and the duration of the fever enter the group treated by alone antibiotic and the group treated by antibiotic and surgical drainage
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children hospitalized for acute pharyngeal infection
Key inclusion criteria (2 listed)
- under 18 years old
- hospitalized for acute pharyngeal infection ( cervical phlegmon, tonsillar abscesses, retropharyngeal or parapharyngeal abscesses)
Key exclusion criteria (3 listed)
- neck infection in the context of immune deficiency
- malignancy or post-traumatic disease
- others deep neck infections: angina, otitis, sinusitis, ethmoiditis, mastoiditis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical description of acute peripharyngeal suppuration
Time frame: 1 day
Clinical description of acute peripharyngeal suppuration suppuration
2 secondary outcomes
Description of therapeutic management
Time frame: 1 day
Description of bacteria in deep neck infections
Time frame: 1 day
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 18 Apr 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Eric JEZIORSKI principal investigator
University Hospital, Montpellier
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 Deep Neck Infections, run by University Hospital, Montpellier 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 2 inclusion and 3 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 18 Apr 2019. 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?
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?
Clinical description of acute peripharyngeal suppuration (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2019.