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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001647
Receipt No. 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

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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)
Email

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
Email skawai@med.toho-u.ac.jp

Sponsor
Institute Division of Rheumatology,Department of Internal Medicine,Toho University School of Mdicine,Tokyo,Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001338

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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