UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the clinical utility of posterior pharyngeal follicles for the diagnosis of influenza
Title of the study (Brief title)	The clinical utility of posterior pharyngeal follicles for the diagnosis of influenza
Region	Japan

Condition
Condition	Upper respiratory tract infection
Classification by specialty	Medicine in general Pneumology Infectious disease Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the clinical utility of posterior pharyngeal follicles for the diagnosis of influenza.
Basic objectives2	Others
Basic objectives -Others	diagnostic performance
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the sensitivity, specificity and odds ratio of posterior pharyngeal follicles for the diagnosis of influenza
Key secondary outcomes	1)Evaluation of the sensitivity, specificity and odds ratio of signs and symptoms for the diagnosis of influenza 2-1) To clarify the association between the time from the onset of symptoms and the diagnostic performance (sensitivity, specificity and odds ratio) of utilizing posterior pharyngeal follicles to diagnose influenza 2-2) To clarify the association between different types of influenza virus (A or B) and the diagnostic performance (sensitivity, specificity and odds ratio) of utilizing posterior pharyngeal follicles to diagnose influenza

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients are included if both of the criteria are met: 1) Patients who present within 72 hours after the onset of symptoms 2) Patients who have a fever of at least 37 degrees celsius and one of the following symptoms: headache, muscle or joint pain, feverishness or chills, fatigue, cough, sore throat, and nasal discharge or stuffiness
Key exclusion criteria	1) Patients with severe conditions, such as altered mental status, shock state, and respiratory failure (peripheral capillary oxygen saturation < 95%) 2) Patients who visit the emergency room and are classified as "Resuscitation" or "Emergent" according to the Japan Triage and Acuity Scale 3) Patients who have signs of meningeal irritation, chest pain, severe abdominal pain, diarrhea (watery stool >3 times/day), hematuria or painful urination Patients with diarrhea are not excluded if they are diagnosed with influenza B 4) Patients who have neoplastic disease, chronic lung disease, symptoms of asthma attack at presentation, congestive heart failure, chronic renal disease, chronic liver disease, central nervous system disorders, diabetes mellitus, immunosuppressive status or are in a non-ambulatory condition 5) Patients who are pregnant 6) Patients unable to make decisions due to an altered mental status or cognitive impairment 7) Patients unable to sufficiently communicate in Japanese 8) Patients who previously participated in this study
Target sample size	300

Research contact person
Name of lead principal investigator	Hiromichi Suzuki
Organization	Tsukuba Medical Center Hospital
Division name	Division of Infectious Diseases, Department of Medicine
Address	1-3-1 Amakubo, Tsukuba, Ibaraki
TEL	029-851-3511
Email	hsuzuki@tmch.or.jp

Public contact
Name of contact person	Hiromichi Suzuki
Organization	Tsukuba Medical Center Hospital
Division name	Division of Infectious Diseases, Department of Medicine
Address	1-3-1 Amakubo, Tsukuba, Ibaraki
TEL	0298-51-3511
Homepage URL
Email	hsuzuki@tmch.or.jp

Sponsor
Institute	Tsukuba Medical Center Hospital
Institute
Department

Funding Source
Organization	Tsukuba Medical Center Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	筑波メディカルセンター病院

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Progress
Recruitment status	Suspended
Date of protocol fixation	2015 Year 11 Month 30 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	[Study design] Prospective observational study [Patients] All patients are recruited and are evaluated for eligibility if both of the following criteria are met: (1) Patients who visit our hospital on predetermined days between December 1, 2015 and April 30, 2016. (2) Patients who present to the emergency department or the general medicine outpatient service. [Variables] - Baseline characteristics Age, sex, comorbidity, previous history of tonsillectomy, medications, current tobacco use, influenza vaccination history, and close contact with cases with confirmed or probable influenza - Signs The date of the onset of illness, cough, feverishness or chills, sore throat, muscle ache or arthralgia, headache, nasal discharge, nasal congestion, fatigue, the date of the onset of a fever, highest temperature (degrees and date), the date of the onset of feverishness or chills, the date of the onset of other symptoms related to the current illness - Physical examination Vital signs (blood pressure, respiratory rate, pulse rate, peripheral capillary oxygen saturation), conjunctivitis, the palate-tongue position (Friedman's criteria Grade I-IV), posterior pharyngeal follicles, the shape of posterior pharyngeal follicles (typical, atypical, islands-like, small), the size of the posterior pharyngeal follicles, perifollicular reddishness, follicles on the soft palate, reddishness of the throat or tonsils, palatal petechiae, pus on the tonsils, tonsil size (Friedman's criteria Grade 0-IV), cervical lymphadenopathy - Influenza surveillance reports (Tsukuba Healthcare Center, 2015-2016)

Management information
Registered date	2015 Year 11 Month 24 Day
Last modified on	2016 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022995