UMIN-CTR Clinical Trial

Public title

Special Investigation - Efficacy/Safety Evaluation of Clarithromycin in Patients With Mycoplasma pneumoniae Pulmonary Infections

Acronym

Special Investigation of Clarithromycin in Patients With Mycoplasma pneumoniae Pulmonary Infections

Scientific Title

Special Investigation - Efficacy/Safety Evaluation of Clarithromycin in Patients With Mycoplasma pneumoniae Pulmonary Infections

Scientific Title:Acronym

Special Investigation of Clarithromycin in Patients With Mycoplasma pneumoniae Pulmonary Infections

Region

Japan

Condition

Pulmonary Infections

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Mycoplasma pneumoniae Pulmonary Infections.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Evaluation of adverse event,
Rate of bacterial eradication

Key secondary outcomes

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

15

years-old

<=

Age-upper limit

49

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Age: over 15 and under 49 years old
(2) Location for treatment: outpatient
(3) Patients with acute upper respiratory tract infection including acute bronchitis (Acute tonsilitis, acute Pharngitis)
(4) Patient who has cough of strong persistent susceptibility, becomes insomnia at night
(5) Patient who judged that the intensity of cough had not passed over a peak
(6) After development of symptoms, the patient for less than three weeks
(7) Patient who has a person of the same cough by the circumferences
(8) Patient to whom expectoration can extract not pus-sputum but pharynx
(9) Patients who do not agree to participate in this study

Key exclusion criteria

(1) Patients enrolled in entry of the study
(2) Patients within 7days of CAM treatment
(3) Patient who has condition in an improvement tendency by medication of other antimicrobial drugs
(4) Patients whose diseases have taboo against the used antibiotics.
(5) Patient with the patient or the past which has a chronic respiratory disease
(6) Patient who has cough owing to foreign-body aspiration
(7) Patient who has cough owing to gastroesophageal regurgitation
(8) Patient who takes a medicine in an ACE inhibitor and has cough owing to it
(9) Patient who has cough owing to it, cough asthma, atopic, the patient that has cough owing to allergic rhinitis
(10) Patient who has cough owing to cardiac disease
(11) Confirmed influenza virus infection.
(12) Patient permitted the unusual shades, such as tuberculosis and a tumor, by the breast image inspection

Target sample size

80

Name of lead principal investigator

1st name
Middle name
Last name	Shigeru Kohno

Organization

Nagasaki University

Division name

Second department of internal medicine

Zip code

Address

1-7-1 Sakamoto Nagasaki

TEL

095-819-7275

Email

s-kohno@nagasaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Koichi IZUMIKAWA

Organization

Nagasaki University

Division name

Second department of internal medicine

Zip code

Address

1-7-1 Sakamoto Nagasaki

TEL

095-819-7273

Homepage URL

Email

koizumik@nagasaki-u.ac.jp

Institute

Shigeru KOHNO

Institute

Department

Personal name

Organization

Taisho Pharmaceutical Co.Ltd.

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

2013

Year

10

Month

04

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

Open public recruiting

Date of protocol fixation

2013

Year

08

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

none

Registered date

2013

Year

10

Month

04

Day

Last modified on

2014

Year

05

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013967