To Compare Efficacy of Intravenous versus Intramuscular Meglumine Antimoniate in Treatment of Cutaneous Leishmaniasis
Design
Clinical trial which is parallel group, double blind, randomized, phase 3 trial.
Settings and conduct
Dermatology Department, CMH Quetta
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA: Patients with biopsy proven cutaneous leishmaniasis and fulfilling the criteria for parenteral treatment with injection meglumine antimoniate.
EXCLUSION CRITERIA: Patients of cutaneous leishmaniasis allergic to antimonial ,having comorbidities (diabetes, hypertension,chronic liver disease,chronic kidney disease, ),baseline ECG abnormality/heart disease,pregnant and breastfeeding women.
Intervention groups
Intervention group A: Patients were given drug via Intravenous route. The drug should be given diluted in 50–200 ml of 5% glucose solution over 30–60 minutes in ICU/HDU with cardiac monitoring.
Intervention group B: Patients were given drug via Intramuscular route. If the volume of injection exceeds 10 ml, it should be divided into two doses: one in each buttock or thigh.
Main outcome variables
Clinical Response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210823052264N4
Registration date:2024-04-03, 1403/01/15
Registration timing:registered_while_recruiting
Last update:2024-04-03, 1403/01/15
Update count:0
Registration date
2024-04-03, 1403/01/15
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-01, 1403/01/13
Expected recruitment end date
2024-10-01, 1403/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Efficacy of Intravenous Versus Intramuscular Injection Meglumine Antimoniate in patients of Cutaneous Leishmaniasis
Public title
Comparison of Efficacy of Intravenous Versus Intramuscular Injection Meglumine Antimoniate in patients of Cutaneous Leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with biopsy proven leishmaniasis plus any of the following: has lesion(s) located in sites not compatible with local treatment for example eyelids
lesions in which scaring would be disabling or severely disfiguring like on face
lesions that will have difficulting in healing like on lower limb or over a joint
lesions involving mucosa or cartilage
lesion ≥4 cm
lesion with sporotrichoid spread
multiple lesions
Exclusion criteria:
patients allergic to antimonials
the lesion is already self-curing
pregnant and breast feeding women
those who refused to accept the diagnostic procedures
patients having mucosal, mucocutaneous or visceral leishmaniasis
Patients with comorbidity (diabetes, hypertension,chronic liver disease,chronic kidney disease) and/or immunosuppression
Patients with baseline ECG abnormalities/Heart disease
Age
From 15 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization done by lottery method, in which small chits of paper are kept in a jar and the patients will be asked to pick one deciding their treatment regimen.
before intervention and 2, 4 , 6 and 8 weeks after intervention until complete healing occur than patient called for followup after 4 weeks
Method of measurement
Clinical Response Evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Patients were given drug via Intravenous route. The drug should be given diluted in 50–200 ml of 5% glucose solution over 30–60 minutes in ICU/HDU with cardiac monitoring
Category
Treatment - Drugs
2
Description
Intervention group B: Patients were given drug via Intramuscular route. If the volume of injection exceeds 10 ml, it should be divided into two doses: one in each buttock or thigh.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
CMH Quetta
Full name of responsible person
Dr Shafia Shaikh
Street address
OFH2 C,H Quetta
City
Quetta
Postal code
08762
Phone
+92 324 4153402
Email
shafiashaikh994@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr. Shafia Shaikh
Street address
ofh2
City
quetta
Postal code
08734
Phone
+92 324 4153402
Email
shafiashaikh994@gmail.com
Grant name
CMH Quetta
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
CMH Quetta
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr. Shafia Shaikh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
ofh2
City
quetta
Province
Balochistan
Postal code
08734
Phone
+92 324 4153402
Email
shafiashaikh994@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr. Shafia Shaikh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
ofh2
City
quetta
Province
Balochistan
Postal code
08734
Phone
+92 324 4153402
Email
shafiashaikh994@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
CMH Quetta
Full name of responsible person
Dr. Shafia Shaikh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
ofh2
City
quetta
Province
Balochistan
Postal code
08734
Phone
+92 324 4153402
Email
shafiashaikh994@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Primary Outcome
When the data will become available and for how long
One month after publication
To whom data/document is available
People Working in academic institutions
Under which criteria data/document could be used
Many
From where data/document is obtainable
shafiashaikh994@gmail.com
What processes are involved for a request to access data/document