UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031513
Receipt number R000035982
Scientific Title Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial
Date of disclosure of the study information 2018/03/01
Last modified on 2022/09/06 12:56:29

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Basic information

Public title

Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial

Acronym

Optimal regimens of Baktar for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases

Scientific Title

Optimal regimens of sulfamethoxazole-trimethoprim for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases: multi-center randomized open label trial

Scientific Title:Acronym

Optimal regimens of Baktar for prophylaxis of pneumocystis pneumonia in patients with systemic rheumatic diseases

Region

Japan


Condition

Condition

Pneumocystis pneumonia

Classification by specialty

Medicine in general Clinical immunology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We designed to show the non-inferiority of the half-dose prophylaxis group by comparing the two groups of conventional therapy group (SMX/TMP of 400/80 mg daily) and half-dose prevention group (SMX/TMP of 200/40 mg daily).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint was non-incidence rate of PCP at week 52.

Key secondary outcomes

The secondary endpoint was drug continuation rate at week 52.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

YES

Dynamic allocation


Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

SMX/TMP of daily 400 mg/80 mg for 52 weeks.

Interventions/Control_2

SMX/TMP of daily 200 mg/40 mg for 52 weeks.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Men and women aged over 20 years
2. Being admitted to our hospitals for diagnosis and/or treatment of new-onset or relapsed systemic rheumatic diseases from 1st April 2018 to 31st March 2021.
3. Have received 0.6 mg/kg/day or more of oral prednisolone or equivalent doses of corticosteroids with or without any immunosuppressant
4. Have not used SMX/TMP, pentamidine isethionate, dapsone, or atovaquone previously
5. Have serum creatinine level within the normal range of the institution.
6. Able and willing to give written informed consent

Key exclusion criteria

1. Have contraindications to SMX/TMP
2. Have a history of PCP
3. Have received biologic agents
4. Have uncontrollable complications
5. Body weight below 40 kg
6. Being pregnant or a nursing woman
7. Being unable to start SMX/TMP within 14 days of starting prednisolone
8. Unable to give informed consent

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Naoto
Middle name
Last name Tamura

Organization

Juntendo university school of medicine

Division name

Department of internal medicine and rheumatology

Zip code

1130033

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

0338133111

Email

yo-abe@juntendo.ac.jp


Public contact

Name of contact person

1st name Yoshiyuki
Middle name
Last name Abe

Organization

Juntendo University School of Medicine

Division name

Department of Internal Medicine and Rheumatology

Zip code

1130033

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan

TEL

0338133111

Homepage URL


Email

yo-abe@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University School of Medicin

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University

Address

2-1-1, Hongo, Bunkyo-Ku, Tokyo

Tel

0338133111

Email

kenkyu5858@juntendo.ac.jp


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

順天堂大学医学部附属順天堂醫院(東京)、順天堂東京江東高齢者医療センター(東京)


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 01 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

89

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

2018 Year 02 Month 28 Day

Date of IRB

2018 Year 02 Month 23 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 28 Day

Last modified on

2022 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035982


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name