UMIN-CTR Clinical Trial

Public title

Study of the clinical efficacy and number of days of administration of cefditoren pivoxil in the treatment of adult acute uncomplicated cystitis

Acronym

Clinical efficacy of cefditoren pivoxil for adult cystitis

Scientific Title

Study of the clinical efficacy and number of days of administration of cefditoren pivoxil in the treatment of adult acute uncomplicated cystitis

Scientific Title:Acronym

Clinical efficacy of cefditoren pivoxil for adult cystitis

Region

Japan

Condition

Adult acute uncomplicated cystitis

Classification by specialty

Medicine in general

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify, in accordance with the UTI Guideline, the clinical usefulness of administering cefditoren pivoxil (Meiact MS(R) Tablets 100 mg) for 3 days and 7 days as a treatment for adult acute uncomplicated cystitis thought to be caused by general bacteria.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

- Bacteriological efficacy at 5~9 days after the completion of treatment.
- Adverse events during the evaluation period (If causality cannot be denied: adverse drug reaction).

Key secondary outcomes

- Clinical efficacy at 5~9 days after the completion of treatment.
- Judgment of recurrence at 4~6 weeks after the completion of treatment.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cefditoren pivoxil (trade name: Meiact MS Tablets 100 mg) will be orally administered at 1 tablet, 3 times per day, for 3 days.

Interventions/Control_2

Cefditoren pivoxil will be orally administered at 1 tablet, 3 times per day, for 7 days.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) Symptoms
A body temperature of <37.5 degree Centigrade, with any of the following subjective symptoms: micturition pain, frequent urination, urinary urgency or lower abdominal pain.
2) Pyuria
Presence of pyuria prior to the start of treatment, meeting any of the following criteria:
- Using primitive urine, >=10 WBC/microL by flow cytometry or >=10 WBC/mm3 when using a counting chamber
- Using primitive urine, a positive test for esterase:
- Microscopic examination of urine sediment: >=5 WBC/hpf

Key exclusion criteria

1) Co-presence of another urinary tract infection in addition to acute uncomplicated cystitis.
2) Symptoms of urinary tract infection within 4 weeks prior to onset of the present infection.
3) Existence of systemic (diabetes mellitus, ongoing administration of an immunosuppressive agent, ongoing long-term administration of steroid, etc.) or local factors that might induce and/or promote a urinary tract infection.
4) Symptoms/findings have improved as a result of administration of another antimicrobial agent.
5) History of allergy, possibly due to cephem antibiotics.
6) A physical constitution that predisposes to development of bronchial asthma, rash, urticaria or other allergic symptoms.
7) Moderate or more severe renal dysfunction.
8) Women who are or may be pregnant, are breast-feeding, or desire to become pregnant during the study drug administration period.
9) Any other reason that the chief investigator judges as rendering a patient inappropriate for enrollment.

Target sample size

120

Name of lead principal investigator

1st name
Middle name
Last name	Koichiro Wada

Organization

Okayama University Hospital

Division name

Department of Urology

Zip code

Address

2-5-1 Shikata-cho, Okayama city

TEL

Email

Name of contact person

1st name
Middle name
Last name	Koichiro Wada

Organization

Okayama University Hospital

Division name

Department of Urology

Zip code

Address

TEL

Homepage URL

Email

gmd17055@s.okadai.jp

Institute

Okayama Urological Research Group

Institute

Department

Personal name

Organization

Okayama Urological Research Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

Date of disclosure of the study information

2013

Year

04

Month

10

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

05

Month

22

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

09

Day

Last modified on

2017

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012217