UMIN-CTR Clinical Trial

Basic information
Public title	Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Acronym	Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Scientific Title	Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Scientific Title:Acronym	Prolonged versus Intermittent beta-lactam Antibiotics Intravenous Infusion Strategy in Sepsis or Septic Shock: A Systematic Review and Meta-Analysis of Randomized Trials.
Region	Japan

Condition
Condition	Sepsis or septic shock
Classification by specialty	Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to conduct systematic review and meta-analysis of the present randomized controlled trials (RCTs) to assess the efficacy of prolonged versus intermittent beta-lactam antibiotics infusion strategy on outcomes in sepsis or septic shock patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	hospital mortality
Key secondary outcomes	attainment of target plasma concentration, clinical cure, adverse event, and occurrence of antibiotic-resistant bacteria

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	We identified studies to be included by following the research question formulated according to the participants, interventions, comparisons and outcomes (PICO) model as follows: P, adult (>=18 years of age) patients admitted to the ICU with a diagnosis of sepsis or septic shock; I, prolonged beta-lactam antibiotics infusion strategy (continuous or extended time [more than 1 hour but not continuous] of intravenous infusion); C, intermittent beta-lactam antibiotics infusion strategy (within 1 hour of intravenous infusion); O, All-cause mortality.
Key exclusion criteria	Under 18 years-old
Target sample size

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Kondo
Organization	Juntendo University Urayasu Hospital
Division name	Department of Emergency and Critical Care Medicine
Zip code	279-0021
Address	2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL	047-353-3111
Email	kondokondou2000@yahoo.co.jp

Public contact
Name of contact person	1st name Yutaka Middle name Last name Kondo
Organization	Juntendo University Urayasu Hospital
Division name	Department of Emergency and Critical Care Medicine
Zip code	279-0021
Address	2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL	047-353-3111
Homepage URL
Email	kondokondou2000@yahoo.co.jp

Sponsor
Institute	Juntendo University Urayasu Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo University Urayasu Hospital
Address	Department of Emergency and Critical Care Medicine
Tel	047-353-3111
Email	kondokondou2000@yahoo.co.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	2020 Year 06 Month 08 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	825
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	2019 Year 04 Month 27 Day
Date of IRB	2019 Year 04 Month 27 Day
Anticipated trial start date	2019 Year 04 Month 27 Day
Last follow-up date	2020 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	<Search method> Electronic detabases were used below. 1. the Cochrane Central Register of Controlled Trials(CENTRAL) 2. MEDLINE 3. Igaku Chuo Zasshi (ICHUSHI) Web <Analysis> Meta-analysis will be performed using the Review Manger, Cochrane systematic review software, version 5.3.5 for Windows.

Management information
Registered date	2020 Year 06 Month 08 Day
Last modified on	2020 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046378