UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients
Title of the study (Brief title)	Epidemiological characteristics of respiratory infection caused by atypical pathogens
Region	Japan

Condition
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

Objectives
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

Assessment
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.

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	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

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, Japan
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, Japan
TEL	029-851-3511
Homepage URL
Email	hsuzuki@tmch.or.jp

Sponsor
Institute	Tsukuba Medical Center Hospital
Institute
Department

Funding Source
Organization	Toyobo
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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

Management information
Registered date	2018 Year 12 Month 22 Day
Last modified on	2018 Year 12 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040230