ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 19 for:    Recruiting, Not yet recruiting, Available Studies | "Tonsillitis"

Improving the Diagnosis of Tonsillitis in Emergency Rooms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02858687
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : August 8, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of tonsillitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tonsillitis tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of tonsillitis after POC tests.

The objective of this study is to implement a new diagnosis strategy relying on the hypothesis that a second pharyngeal swab would improve the etiological diagnosis of tonsillitis of at least 5%.


Condition or disease Intervention/treatment Phase
Tonsillitis Other: Nasopharyngeal swab Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4320 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2013
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Patients with clinical diagnosis of tonsillitis Other: Nasopharyngeal swab



Primary Outcome Measures :
  1. Percentage of patients admitted for tonsillitis with a confirmed etiological diagnosis of tonsillitis [ Time Frame: 1 day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient admitted at hospital for tonsillitis requiring, for the emergency physician, a microbiological examination with a "POC tonsillitis kit."
  • Patient who has freely signed the informed written consent
  • Patient affiliated to a social security scheme

Exclusion Criteria:

  • Pregnant woman, parturient or nursing
  • Adult patient under guardianship
  • Patient deprived of liberty under court order
  • Patient refusing or unable to sign the informed consent form.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858687


Contacts
Contact: Michel DRANCOURT 04 91 38 55 19 ext +33 michel.drancourt@ap-hm.fr
Contact: Alexandra GIULIANI 04 91 38 28 70 alexandra.giuliani@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Michel DRANCOURT, Pr    04 91 38 55 19 ext +33    michel.drancourt@ap-hm.fr   
Contact: Alexandra GIULIANI    04 91 38 28 70 ext +33    alexandra.giuliani@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Catherine GEINDRE Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02858687     History of Changes
Other Study ID Numbers: 2012-46
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases