UMIN-CTR Clinical Trial

Public title

Evaluation of the clinical utility of posterior pharyngeal follicles for the diagnosis of influenza

Acronym

The clinical utility of posterior pharyngeal follicles for the diagnosis of influenza

Scientific Title

Evaluation of the clinical utility of posterior pharyngeal follicles for the diagnosis of influenza

Scientific Title:Acronym

The clinical utility of posterior pharyngeal follicles for the diagnosis of influenza

Region

Japan

Condition

Upper respiratory tract infection

Classification by specialty

Medicine in general	Pneumology	Infectious disease
Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiromichi Suzuki

Organization

Tsukuba Medical Center Hospital

Division name

Division of Infectious Diseases, Department of Medicine

Zip code

Address

1-3-1 Amakubo, Tsukuba, Ibaraki

TEL

029-851-3511

Email

hsuzuki@tmch.or.jp

Name of contact person

1st name
Middle name
Last name	Hiromichi Suzuki

Organization

Tsukuba Medical Center Hospital

Division name

Division of Infectious Diseases, Department of Medicine

Zip code

Address

1-3-1 Amakubo, Tsukuba, Ibaraki

TEL

0298-51-3511

Homepage URL

Email

hsuzuki@tmch.or.jp

Institute

Tsukuba Medical Center Hospital

Institute

Department

Personal name

Organization

Tsukuba Medical Center Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

筑波メディカルセンター病院

Date of disclosure of the study information

2015

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Suspended

Date of protocol fixation

2015

Year

11

Month

30

Day

Date of IRB

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

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)

Registered date

2015

Year

11

Month

24

Day

Last modified on

2016

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022995