UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011964 |
|---|---|
| Receipt number | R000013967 |
| Scientific Title | Special Investigation - Efficacy/Safety Evaluation of Clarithromycin in Patients With Mycoplasma pneumoniae Pulmonary Infections |
| Date of disclosure of the study information | 2013/10/04 |
| Last modified on | 2014/05/28 11:58:34 |
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Basic information
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
Condition
Pulmonary Infections
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
Primary outcomes
Evaluation of adverse event,
Rate of bacterial eradication
Key secondary outcomes
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
| 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
Research contact person
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
s-kohno@nagasaki-u.ac.jp
Public contact
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
koizumik@nagasaki-u.ac.jp
Sponsor or person
Institute
Shigeru KOHNO
Institute
Department
Personal name
Funding Source
Organization
Taisho Pharmaceutical Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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
Other related information
none
Management information
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
