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UMIN-CTR Clinical Trial |
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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 |
Basic information | ||
Public title | A prospective study of Trimethoprime-sulfamethoxazole(TMP/SMX) for prevention of Pneumocystis pneumonia(PCP) in patients under immunosuppressive therapy
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Acronym | Prevention study for PCP by TMP/SMX
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Scientific Title | A prospective study of Trimethoprime-sulfamethoxazole(TMP/SMX) for prevention of Pneumocystis pneumonia(PCP) in patients under immunosuppressive therapy
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Scientific Title:Acronym | Prevention study for PCP by TMP/SMX
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Region |
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Condition | |||||
Condition | The patients with rheumatic diseases who are receiving more than 30mg/day
of prednisolone |
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Classification by specialty |
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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 |
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Interventions/Control_1 | Daily a week administration of a TMP/SMX(Bacter) tablet
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |