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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022032
Receipt No. R000025395
Scientific Title A randomized comparative study between intravenous and intramuscular scorpion antivenom regimens in a tertiary center in Upper Egypt
Date of disclosure of the study information 2016/05/01
Last modified on 2018/08/17

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Basic information
Public title A randomized comparative study between intravenous and intramuscular scorpion antivenom regimens in a tertiary center in Upper Egypt
Acronym Intravenous and intramuscular scorpion antivenom
Scientific Title A randomized comparative study between intravenous and intramuscular scorpion antivenom regimens in a tertiary center in Upper Egypt
Scientific Title:Acronym Intravenous and intramuscular scorpion antivenom
Region
Africa

Condition
Condition Scorpion envenomation
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to compare the efficacy of scorpion antivenom following intramuscular, intravenous routes of administration regarding the fate and occurrence of fatal complications.
Basic objectives2 Others
Basic objectives -Others the efficacy of scorpion antivenom following intramuscular, intravenous routes of administration
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the efficacy of scorpion antivenom following intramuscular, intravenous routes of administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 the efficacy of scorpion antivenom following intramuscular route of administration
Interventions/Control_2 the efficacy of scorpion antivenom following intravenous route of administration
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
1 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria Patients presented with a definite history of scorpion sting. Presented to Assiut university hospital for children within 6 hours of the sting. Observation for at least 24 hours.

Key exclusion criteria Patients with no definite history of scorpion sting.Presentation after 6 hours of the sting.Observation of less than 24 hours.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Khaled Saad
Organization Assiut university
Division name pediatric department
Zip code
Address Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
TEL +20882413683
Email khaled.ali@med.au.edu.eg

Public contact
Name of contact person
1st name
Middle name
Last name Khaled Saad
Organization Assiut University, Assiut, Egypt
Division name Pediatric Department
Zip code
Address Assiut University, Assiut, Egypt
TEL +20882368373
Homepage URL
Email med@aun.edu.eg

Sponsor
Institute Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
Institute
Department

Funding Source
Organization Faculty of medicine, University of Assiut, Assiut 71516, Egypt.
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
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
2016 Year 05 Month 01 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
Studies (CBC, cardiac enzymes, renal function and serum electrolytes), need for mechanical ventilation and outcome. Myocarditis, cardiogenic shock, ICU admission, need for mechanical ventilation, mean hospital stay and mortality were significantly lower in those received intravenous antivenom compared with those received intramuscular or both routes of administration
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
2016 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 25 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 23 Day
Last modified on
2018 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025395

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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