UMIN-CTR Clinical Trial

Public title

Minimal dose oral cephalosporin regimen(MDC regimen), a new empiric therapy for the treatment of uncomplicated cystitis in women during the era of an increasing prevalence of drug-resistant pathogens.

Acronym

Minimal-dose cephalosporinregimen(MDC regimen) for the treatment of female uncomplicated cystitis.

Scientific Title

Minimal dose oral cephalosporin regimen(MDC regimen), a new empiric therapy for the treatment of uncomplicated cystitis in women during the era of an increasing prevalence of drug-resistant pathogens.

Scientific Title:Acronym

Minimal-dose cephalosporinregimen(MDC regimen) for the treatment of female uncomplicated cystitis.

Region

Japan

Condition

Acute uncomplicated cystitis in wpmen.

Classification by specialty

Urology

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To show that the MDC regimen is the most suitable regimen in the treatment of uncomplicated cystitis in women, since this regimen is most cost-effective and not associated with untoward reaction. Further, this regimen is adequate for the long prophylactic treatment of frequent recurrent cystitis since this regimen dose not select drug-resistant pathogens in the bowel.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

Promptly getting asymptomatic and pyuria is cleared, and pathogens are eradicated from urine in a week, and no recurrence during the long term preventive treatment in the patients having suffered frequent recurrence.

Key secondary outcomes

No association of untoward reaction such as gastric symptom and anaphylactic reaction. Further, no recurrence with drug resistant pathogen during the long term treatment for prevention of frequent recurrence.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Prescriibe 40mg cefaclor/day for a week that is divided in two doses onto empty stomch.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Sexually active women or older, including women after climacterium.

Key exclusion criteria

Patients who have strucural of functional abnormality in the urinary tract.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Yorio Naide

Organization

Hannnou Seiwa Hospital

Division name

Consualtant

Zip code

Address

137 Shimokaji, Hannnou, Saitama, Japan

TEL

+81-42-974-2311

Email

yprio823@jcom.home.ne.jp

Name of contact person

1st name
Middle name
Last name	Yorio Naide

Organization

Hannnou Seiwa Hospital

Division name

Consultant

Zip code

Address

137 Shimokaji, Hannnou, Saitama, Japan

TEL

+81-42-974-2311

Homepage URL

Email

yorio823@jcom.home.ne.jp

Institute

Yorio Naide

Institute

Department

Personal name

Organization

Yorio Naide

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Department of Infectious Diseases, School of Medicine, Keio University
Department of Infectious Diseases, School of Medicine, Kitasato University

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

公立福生病院（東京都）
飯能整形外科病院（埼玉県）

Date of disclosure of the study information

2015

Year

07

Month

10

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

Results

All of 100 women promptly became asymptomatic and pyuria disappeaed. Sixty-two women were free of introital colonization and recurrence within 4 months was noticed in 5. 38 women had large number of introital colonization though catheterized urines were sterile, among them 10 women were free of colonization in 1 month. In 28 women recurrence was noticed in 18 in 2 months, and in 5 long-term medication was done due to frequent recurrences.

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

Recruitment status

Completed

Date of protocol fixation

2005

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2005

Year

04

Month

01

Day

Last follow-up date

2007

Year

04

Month

30

Day

Date of closure to data entry

2007

Year

06

Month

01

Day

Date trial data considered complete

2007

Year

06

Month

01

Day

Date analysis concluded

2007

Year

07

Month

01

Day

Other related information

Preceeding to treatment study, effect of medication on bowel flora was examined using anal smear cultures. Anal smear cultures of women who were medicated with conventional dosses, all E. coli strains were resistant to cefaclor. All women who were medicated with small dose, however, all E. coli strains remained susceptible to cefaclor.

Registered date

2015

Year

06

Month

24

Day

Last modified on

2015

Year

06

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020612