UMIN-CTR Clinical Trial

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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