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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025193
Receipt No. R000028982
Scientific Title Do we use antibiotics judiciously enough? A study in JPMC's Accident and Emergency Department
Date of disclosure of the study information 2017/01/01
Last modified on 2016/12/08

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Basic information
Public title Do we use antibiotics judiciously enough? A study in JPMC's Accident and Emergency Department
Acronym Appropriate antibiotic use in a major emergency department in Pakistan.
Scientific Title Do we use antibiotics judiciously enough? A study in JPMC's Accident and Emergency Department
Scientific Title:Acronym Appropriate antibiotic use in a major emergency department in Pakistan.
Region
Asia(except Japan)

Condition
Condition Minor injuries presenting to the Emergency Department.
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether antibiotics must be given to all patients presenting with unclean wounds.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of wound infection seven days after presentation to the emergency department for minor injury.
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Received antibiotics according to predetermined criteria (i.e. only high risk patients received antibiotics) for three days (prophylactically), or 7 days (if the wound was already infected). Dose was determined on a case-by-case basis by the treating physician.
Interventions/Control_2 All patients with open wounds received antibiotics for 5 days (prophylactically), or 7 days (if the wound was already infected).Dose was determined on a case-by-case basis by the treating physician.
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
12 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Patients presenting with any open wounds; vitally stable; and not requiring urgent referral to any department
Key exclusion criteria Patients greater than 60 years, or younger than 12 years.
Immunocompromised.
Those with chronic renal failure, diabetes mellitus, or chronic liver disease.
Those with prostheses.
Those already taking antibiotics.
Target sample size 206

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Omar Abbas Ahmed Malik
Organization Dow University of Health Sciences
Division name Dow Medical College
Zip code
Address 31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL 00923362363569
Email omar.a.a.malik@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Omar Abbas Ahmed Malik
Organization Dow University of Health Sciences
Division name Dow Medical College
Zip code
Address 31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL 00923362363569
Homepage URL
Email omar.a.a.malik@gmail.com

Sponsor
Institute Jinnah Post Graduate Medical Centre.
Institute
Department

Funding Source
Organization (NO GRANTS OR 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
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
2017 Year 01 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
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
2015 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 08 Day
Last modified on
2016 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028982

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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