UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001647 |
|---|---|
| Receipt number | R000001338 |
| Scientific Title | A prospective study of Trimethoprime-sulfamethoxazole(TMP/SMX) for prevention of Pneumocystis pneumonia(PCP) in patients under immunosuppressive therapy |
| Date of disclosure of the study information | 2009/01/20 |
| Last modified on | 2012/02/20 09:27:49 |
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Basic information
Public title
A prospective study of Trimethoprime-sulfamethoxazole(TMP/SMX) for prevention of Pneumocystis pneumonia(PCP) in patients under immunosuppressive therapy
Acronym
Prevention study for PCP by TMP/SMX
Scientific Title
A prospective study of Trimethoprime-sulfamethoxazole(TMP/SMX) for prevention of Pneumocystis pneumonia(PCP) in patients under immunosuppressive therapy
Scientific Title:Acronym
Prevention study for PCP by TMP/SMX
Region
| Japan |
Condition
Condition
The patients with rheumatic diseases who are receiving more than 30mg/day
of prednisolone
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate better prevention by TMP/SMX against PCP
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Incidence of PCP
Key secondary outcomes
1)Positive rate of Pneumocystis polymerase chain reaction in sputum
2)Incidence of the increased plasma level of beta-D-gulucan
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Daily a week administration of a TMP/SMX(Bacter) tablet
Interventions/Control_2
Twice a week administration of a TMP/SMX(Bacter) tablet
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
In patients with rheumatic disease as follows:
1.From 20 to 75 years-old
2.Patients with informed consent
3.Patients received more than 30mg/day of prednisolone
Key exclusion criteria
1.On TMP/SMX
2.Suffering from PCP
3.Complicated with serious liver and/or renal disfunction,cytopenia
4.Allergy to TMP/SMX
5.Pregnant,and/or nursing
6.In approppriate patients decided by doctors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Kwai |
Organization
Department of Internal Medicine, Toho University School of Mdicine
Division name
Division of Rheumatology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku Tokyo 143-8541,Japan
TEL
03-3762-4151(ext.6591)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Kwai |
Organization
Department of Internal Medicine, Toho University School of Mdicine, Tokyo,Japan
Division name
Division of Rheumatology
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku Tokyo 143-8541,Japan.
TEL
03-3762-4151(ext.6591)
Homepage URL
skawai@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Rheumatology,Department of Internal Medicine,Toho University School of Mdicine,Tokyo,Japan
Institute
Department
Personal name
Funding Source
Organization
Toho University School of Mdicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
東邦大学医療センター大森病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 20 | Day |
Last modified on
| 2012 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001338
