UMIN-CTR Clinical Trial

Basic information
Public title	Open-label randomized comparative study of cefepime vs. meropenem in adults with moderate to severe aspiration pneumonia
Acronym	Cefepime vs. meropenem in moderate to severe aspiration pneumonia
Scientific Title	Open-label randomized comparative study of cefepime vs. meropenem in adults with moderate to severe aspiration pneumonia
Scientific Title:Acronym	Cefepime vs. meropenem in moderate to severe aspiration pneumonia
Region	Japan

Condition
Condition	Aspiration pneumonia
Classification by specialty	Pneumology Infectious disease Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare clinical effectiveness between cefepime and meropenem in adult patients with moderate to severe aspiration 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	Device,equipment
Interventions/Control_1	cefepime 1g dose parenteral infusion, every 8 hrs, for 4-14 days. May be adjusted when renal failure. Erythromycin 500mg parenteral infusion every 12 hrs, or Azithromycin 500mg parenteral infusion every 24hrs may be added in severe cases.
Interventions/Control_2	meropenem 0.5g dose parenteral infusion, every 8 hrs, for 4-14 days. May be adjusted when renal failure. Erythromycin 500mg parenteral infusion every 12 hrs, or Azithromycin 500mg parenteral infusion every 24hrs may be added in severe cases.
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 moderate to severe pneumonia and required initial parenteral treatment. (2)At least one of the following conditions of risk for aspiration pneumonia: neurological disorders (cerebrovascular diseases, neuromuscular diseases, dementia, etc.), bed-ridden, oral/pharyngeal/laryngeal disorder, gastro-esophageal disorder (esophageal diverticulum, achalasia, systemic sclerosis, esophageal cancer, GERD, post-gastrectomy (total or partial), hiatal hernia, etc.), usage of sedatives or hypnotics, insertion of a nasogastric tube, subjective or observed aspiration/choking/dysphagia, episode of vomiting. (3)Radiological appearance of a new and/or progressive pulmonary infiltrate(s) (4) 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 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	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Isao Ito
Organization	Kyoto University
Division name	Department of Respiratory Medicine
Zip code
Address	54 Shogoin-kawaharacho, Sakyo, Kyoto, 606-8507, Japan
TEL	075-751-3884
Email

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

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
Address
Tel
Email

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	Completed
Date of protocol fixation	2008 Year 06 Month 13 Day
Date of IRB	2008 Year 09 Month 01 Day
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 02 Day
Last modified on	2021 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001642