UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049903 |
|---|---|
| Receipt number | R000056837 |
| Scientific Title | Study on the efficacy and safety of cephalexin for acute uncomplicated cystitis |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2023/06/27 12:48:02 |
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Basic information
Public title
Study on the efficacy and safety of cephalexin for acute uncomplicated cystitis
Acronym
Studies on cephalexin for acute uncomplicated cystitis
Scientific Title
Study on the efficacy and safety of cephalexin for acute uncomplicated cystitis
Scientific Title:Acronym
Studies on cephalexin for acute uncomplicated cystitis
Region
| Japan |
Condition
Condition
acute uncomplicated cystitis
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of cephalexintreatment for acute uncomplicated cystitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary efficacy from the end of the medication to 10 days after the end of the medication
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cephalexin continuous formulation 500 mg (potency) twice daily for 7 days.
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
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with subjective symptoms of urinary pain, frequency, urinary urgency, and lower abdominal pain. However, patients with no symptoms of cystitis within 4 weeks prior to the current onset.
Pyuria Patients whose pyuria prior to initiation of medication meets any of the following criteria
Urine occult blood test by non-centrifugal urine 10 WBCs/hpf or greater
Urine detector method with non-centrifuged urine positive
Urine sediment sample positive 5 WBCs/hpf or greater
Key exclusion criteria
1) Patients who received other antimicrobial agents prior to the start of study drug and whose symptoms are already improving.
2) Patients who have received a cephalosporin antibiotic within 1 week prior to the start of study drug administration
3) Patients with severe infections that are not expected to respond to oral therapy
4) Patients with serious underlying diseases or complications that make it difficult to evaluate the efficacy and safety of the study drug
5) Patients with a history of allergy to cephalosporins
6) Patients with severe cardiac or hepatic dysfunction
7) Patients with moderate or severe renal dysfunction (serum creatinine level should be 2 mg/dL or higher)
8) Patients with epilepsy or other convulsive disorders or a history of such disorders
9) Pregnant women, women who may be pregnant, and lactating women
10) Other patients deemed inappropriate by the attending physician
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Takahashi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
stakahas@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | yasuda |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Control & Laboratory Medicine
Zip code
060-8543
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
yasuda7jpe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
S1 W17, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056837
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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