Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000024640
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
19/07/2005
Date last updated
19/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
G-CSF for the prevention of mortality from severe melioidosis in Ubon Ratchathani, Thailand
Scientific title
G-CSF for the prevention of mortality from severe melioidosis in Ubon Ratchathani, Thailand
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe sepsis due to melioidosis 87 0
Condition category
Condition code
Infection 108 108 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study: Lenograstim 263mcg iv daily for 3 days
Intervention code [1] 32 0
Treatment: Drugs
Comparator / control treatment
Control: Normal saline
Control group
Placebo

Outcomes
Primary outcome [1] 134 0
28-day mortality
Timepoint [1] 134 0
Secondary outcome [1] 296 0
Markers of organ dysfunction
Timepoint [1] 296 0
Secondary outcome [2] 297 0
Adverse reactions
Timepoint [2] 297 0
Secondary outcome [3] 298 0
Duration of fever
Timepoint [3] 298 0
Secondary outcome [4] 299 0
Time to resolution of shock
Timepoint [4] 299 0
Secondary outcome [5] 300 0
Duration of ventilation
Timepoint [5] 300 0
Secondary outcome [6] 301 0
Treatment failure
Timepoint [6] 301 0

Eligibility
Key inclusion criteria
Severe sepsis (systemic inflammatory response syndrome and evidence of organ dysfunction) due to melioidosis suspected on clinical groups.
Minimum age
14 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children <14 years, pregnancy, hypersensitivity to study drugs, haematological malignancy, febrile neutropenia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prepackaged boxes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block randomziation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 143 0
Charities/Societies/Foundations
Name [1] 143 0
Royal Australasian College of Physicians
Country [1] 143 0
Australia
Funding source category [2] 144 0
Charities/Societies/Foundations
Name [2] 144 0
Flinders Medical Foundation
Country [2] 144 0
Australia
Funding source category [3] 145 0
Commercial sector/Industry
Name [3] 145 0
Merck Australia
Country [3] 145 0
Australia
Funding source category [4] 146 0
Other Collaborative groups
Name [4] 146 0
Wellcome Trust-Oxford University-Mahidol University Tropical Medicine Research Programme
Country [4] 146 0
United Kingdom
Funding source category [5] 147 0
Hospital
Name [5] 147 0
Sappasithiprasong Hospital
Country [5] 147 0
Thailand
Primary sponsor type
University
Name
Menzies School of Health Research, Charles Darwin University
Address
Country
Australia
Secondary sponsor category [1] 104 0
University
Name [1] 104 0
Wellcome Trust-Oxford University-Mahidol University Tropical Medicine Research Programme
Address [1] 104 0
Country [1] 104 0
United Kingdom
Secondary sponsor category [2] 105 0
Hospital
Name [2] 105 0
Sappasithiprasong Hospital
Address [2] 105 0
Country [2] 105 0
Thailand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 890 0
Ministry of Public Health of the Royal Government of Thailand
Ethics committee address [1] 890 0
Ethics committee country [1] 890 0
Thailand
Date submitted for ethics approval [1] 890 0
Approval date [1] 890 0
Ethics approval number [1] 890 0
Ethics committee name [2] 891 0
Human Research Ethics Committee, Menzies School of Health Research
Ethics committee address [2] 891 0
Ethics committee country [2] 891 0
Australia
Date submitted for ethics approval [2] 891 0
Approval date [2] 891 0
Ethics approval number [2] 891 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35691 0
Address 35691 0
Country 35691 0
Phone 35691 0
Fax 35691 0
Email 35691 0
Contact person for public queries
Name 9221 0
Allen Cheng
Address 9221 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 9221 0
Australia
Phone 9221 0
+61 8 89225196
Fax 9221 0
Email 9221 0
[email protected]
Contact person for scientific queries
Name 149 0
Allen Cheng
Address 149 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Country 149 0
Australia
Phone 149 0
+61 8 89225196
Fax 149 0
Email 149 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.