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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001352
Receipt No. R000001645
Scientific Title Open-label randomized comparative study of cefepime vs. meropenem in adults with severe community-acquired pneumonia
Date of disclosure of the study information 2008/09/30
Last modified on 2021/03/14

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Basic information
Public title Open-label randomized comparative study of cefepime vs. meropenem in adults with severe community-acquired pneumonia
Acronym Comparative study of cefepime vs. meropenem in severe community-acquired pneumonia
Scientific Title Open-label randomized comparative study of cefepime vs. meropenem in adults with severe community-acquired pneumonia
Scientific Title:Acronym Comparative study of cefepime vs. meropenem in severe community-acquired pneumonia
Region
Japan

Condition
Condition community-acquired pneumonia
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare clinical effectiveness between cefepime and meropenem in adult patients with severe community-acquired pneumonia.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Clinical response at the end of therapy, days 11-14
Key secondary outcomes Early clinical response at days 4 and 7
Bacteriological response at days 11-14 (in bacteriologically evaluable patients)
Survival at day 30

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cefepime 1g dose parenteral infusion, every 8 hrs, for 4-14 days.
Erythromycin 500mg dose parenteral infusion every 6 hrs, or Azithromycin 500mg parenteral infusion every 24hrsfor 4-14 days.
May be adjusted when renal failure.
Interventions/Control_2 Meropenem 0.5g dose parenteral infusion, every 8 hrs, for 4-14 days.
Erythromycin 500mg dose parenteral infusion every 6 hrs, or Azithromycin 500mg parenteral infusion every 24hrs for 4-14 days.
May be adjusted when renal failure.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Hospital-admitted patients aged 15 yrs or more with a diagnosis of severe community-acquired pneumonia and required initial parenteral treatment
(2) Radiological appearance of a new and/or progressive pulmonary infiltrate(s)
(3) At least two of the followings: cough, sputum or change of sputum character (increased volume and/or purulence), dyspnea, tachypnea, abnormal breathing sound (wheeze etc.), pleuritic chest pain, auscultatory findings on chest examination consistent with the lung infiltrate, documented axillary body temperature > or = 37.5C within the past 24hrs, rigors and/or chills, general malaise, and a WBC count of > or = 10,000/mm3 or < 3,000/mm3.
Key exclusion criteria (1) Hospital-acquired pneumonia
(2) Hospitalization within 60 days prior to the development of the symptom(s)
(3) Immunocompromising disease or receipt of immunopompromising therapy
(4) Active lung cancer
(5) Terminal illness
(6) Pregnancy or breast-feeding
(7) Known allergy to the indicated antibiotics
(8) Other infiltrative diseases (e.g. radiation pneumonitis, organizing pneumonia, drug-induced pneumonia, obstructive pneumonia etc.)
(9) Tuberculosis, fungal infection
(10) Empyema
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Isao
Middle name
Last name Ito
Organization Kyoto University
Division name Department of Respiratory Medicine
Zip code 6068507
Address Shogoin-kawaracho 54, Sakyo, Kyoto, Japan
TEL 0757513830
Email isaoito@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Seizo
Middle name
Last name Kadowaki
Organization Ono Municipal Hospital
Division name Internal Medicine
Zip code 675-1332
Address 323 Nakamachi, Ono-city, 675-1332, Japan
TEL 0794-63-2020
Homepage URL
Email kadowaki-seizo@hospital.ono.hyogo.jp

Sponsor
Institute Ono Municipal Hospital
Institute
Department

Funding Source
Organization Dainippon Sumitomo Pharma Co., Ltd.
Taisho Toyama Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Comittee, Ono Municipal Hospital
Address 323 Nakamachi, Ono-city, 675-1332, Japan
Tel 0794-63-2020
Email kadowaki-seizo@hospital.ono.hyogo.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
2008 Year 09 Month 30 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 No longer recruiting
Date of protocol fixation
2008 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 09 Month 03 Day
Last modified on
2021 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001645

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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