UMIN-CTR Clinical Trial

Public title

Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients

Acronym

Epidemiological characteristics of respiratory infection caused by atypical pathogens

Scientific Title

Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients

Scientific Title:Acronym

Epidemiological characteristics of respiratory infection caused by atypical pathogens

Region

Japan

Condition

Respiratory tract infection/atypical pathogen/Mycoplasma pneumoniae/Chlamydophila pneumoniae/Bordetella pertussis/Bordetella paraperutussis

Classification by specialty

Medicine in general	Pneumology	Infectious disease
Pediatrics	Laboratory medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the epidemiological and clinical characteristics of respiratory tract infection caused by atypical pathogens in primary care patients.

Basic objectives2

Others

Basic objectives -Others

The other objectives of this study are: 1) to examine the reliability of disease probabilities for atypical pathogen infection assessed by the treating physicians, referring to the results of molecular examinations; 2) to compare the antimicrobial prescription patterns among patients with positive and negative test results for atypical pathogens; 3) to compare the antimicrobial prescription patterns between Mycoplasma pneumoniae patients with and without the macrolide resistance associated mutations; 4) to evaluate the utility of the Heckerling clinical decision rule for the diagnosis of pneumonia. This study further attempts to detect the pathogens of respiratory tract infection, analyzing the frozen residual samples with the automated molecular examination equipment.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The epidemiological characteristics of respiratory tract infection caused by atypical pathogens (Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydophila psittasi, Bordetella pertussis, Bordetella parapertussis).

Key secondary outcomes

1) The sensitivity, specificity, positive/negative predictive value, and odds ratio of the clinical signs and symptoms for the diagnosis of respiratory infection caused by different atypical pathogens.
2) The agreement between the clinical disease probabilities of atypical pathogen infection assessed by the treating physicians and the results of molecular examinations.
3) The changes in the reliability of disease probabilities assessed by the treating physicians during the study period.
4) The differences in the antimicrobial prescription patterns between patients with positive and negative test results for atypical pathogens.
5) The differences in the antimicrobial prescription patterns between Mycoplasma pneumoniae patients with and without the macrolide resistance associated mutation.
6) The sensitivity, specificity, positive/negative predictive value and odds ratio of the Heckerling clinical decision rule for the diagnosis of community-acquired pneumonia.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are eligible for this study if all of the following criteria are met:
1) Patients are able to provide written informed consent
2) Patients have both fever (one degree higher than normal body temperature or body temperature > 37 degrees Celsius) and cough, one of which persists at least three days
3) Patients are treated by the study investigators

Key exclusion criteria

Patients are excluded if one of the following criteria is met.
1) Patients or proxies are unable to provide informed consent in Japanese
2) Patients have severe conditions (e.g., altered mental status and shock state), and sample collections are unable to be performed safely
3) Patients have chronic lung disease with multiple episodes of acute exacerbation
4) Patients have clinically evident sinusitis or tonsillitis with tonsillar exudate and swelling
5) Patients have lung tuberculosis, lung mycosis, or nontuberculous mycobacterial lung disease
6) Patients are diagnosed with hospital-acquired pneumonia or healthcare-associated pneumonia
7) Patients have dysphagia or a history of aspiration
8) Patients have obstructive pneumonia, empyema, or lung abscess

Target sample size

4000

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, Japan

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, Japan

TEL

029-851-3511

Homepage URL

Email

hsuzuki@tmch.or.jp

Institute

Tsukuba Medical Center Hospital

Institute

Department

Personal name

Organization

Toyobo

Organization

Division

Category of Funding Organization

Profit organization

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

Date of disclosure of the study information

2018

Year

12

Month

22

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

Enrolling by invitation

Date of protocol fixation

2016

Year

11

Month

15

Day

Date of IRB

Anticipated trial start date

2016

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

(Variables)
#Demographic data
Age, sex, residential status, the epidemic data of atypical pathogen infection in local communities where patients come from, close contact with cases with atypical pathogen infection, comorbidities, the history of influenza vaccination, the number of visits to hospitals/clinics, the prescribed antibiotics before examinations, smoking history

#Signs and symptoms
The progression of illness, fever, cough, sputum production, nasal obstruction, myalgia, arthralgia, headache, fatigue, chill, feverish sensation, diarrhea, vomiting

#Physical examination
Blood pressure, respiratory rate, pulse rate, body temperature, saturation of peripheral oxygen, consciousness, tonsillar swelling, tonsillar exudate, pharyngeal erythema, cervical lymphadenopathy, skin rash, an abnormal respiratory sound on chest auscultation

#Laboratory findings
Plain chest radiography, chest computed tomography, white blood cell and differential, C-reactive protein, lactate dehydrogenase, blood urea nitrogen, the results of molecular examinations*
* GENECUBE Mycoplasma, GENECUBE Chlamydia pneumoniae and GENECUBE Bordetella pertussis are used for the analysis of fresh nasopharyngeal or pharyngeal samples to detect atypical pathogens. As an additional analysis, BIOFIRE FILMARRAY multiplex PCR system and Respiratory Panel are used to identify causative pathogens of respiratory infection using frozen residual samples. Regarding the analysis of macrolide resistance, GENECUBE Mycoplasma is employed for M. pneumoiniae and BIOFIRE FILMARRAY multiplex PCR system and Respiratory Panel are applied for other pathogens.

#Others
The duration from the symptom onset to examinations, the disease probabilities of atypical pathogen infection assessed by the treating physicians, the prescribed antibiotics, a contact of swab with the posterior pharyngeal wall or the nasopharyngeal wall during sample collection, the extent of visible area in pharynx during a pharyngeal inspection

Registered date

2018

Year

12

Month

22

Day

Last modified on

2018

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040230