Home » Trials » SLCTR/2010/001
Treatment of children with Typhoid fever: a comparative trial of Cotrimoxazole and Ampicillin in General Hospital Vavuniya.
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SLCTR Registration Number
SLCTR/2010/001
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Treatment of children with Typhoid fever: a comparative trial of Cotrimoxazole and Ampicillin in General Hospital Vavuniya.
Public Title of Trial
Comparison of two antibiotics in the treatment of typhoid fever in children in General Hospital, Vavuniya
Disease or Health Condition(s) Studied
Typhoid fever
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC/09-011 (Ethics Review Committee of the Sri Lanka Medical Association)
What is the research question being addressed?
We are currently experiencing an outbreak of Typhoid fever in Vavuniya district. We observed incidentally that patients respond well to the two antibiotics, cotrimoxazole and ampicillin. Therefore we decided to investigate this scientifically by carrying out a randomized controlled trial. ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
This is an interventional study where typhoid cases and controls will be selected from patients admitted to the paediatric ward within the age group of 6 years to 12 years. Randomization will be done using a standard randomization table. To achieve 0.05 level of significance and 90% power the minimum required sample will be 124 (62 in each group) according to the equation, All clinically suspected patients with Typhoid fever (Clinically suspected cases were identified according to MMWR 1997 case definition).
Treatment is either with oral Cotrimoxazole or intravenous Ampicillin. Cotrimoxazole - Dose calculation:- 480mg twice daily Duration:-10 days Brand:-Paediatric Cotrimoxazole tablets BP 480mg ( manufactured by Interpharm PVT limited, Madapatha Road, Piliyandala, Sri Lanka) Preparation:-tablets ( strength – 480mg ) Ampicillin – Dose calculation:-50mg/kg every 6 hours Duration:- 10 days Brand:-Ampicillin Sodium for injection 250mg ( Belco Pharma, 515, M.I.E Bahadurgah, A.O- A- 3314, Paschim Vihar, New Delhi, 110063 )
Inclusion criteria
All clinically suspected patients with Typhoid fever
Exclusion criteria
Primary outcome(s)
|
1.
The primary outcome measure will be the duration taken for the complete resolution of fever which is considered as maintaining normal body temperature for 48 hours or more, Development of adverse effects and disease related complications such as intestinal perforation, perforation or paralytic ileus will be assessed as secondary outcome measures |
[ Day of fever free for 48 hours ] |
Secondary outcome(s)
|
1.
|
[ Daily assessment ] |
Target number/sample size
124 (62 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2009-12-12
Anticipated end date
2011-01-13
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2009-12-04
Approval number
ERC/09-011
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Sri Lanka Medical Association, |
| Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
| Telephone: | +94-11-2693324 |
| Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr V. Kiridana
Consultant Paediatrician
14/2, Deveni Rajasingha Mawatha, Gatambe, Kandy
0772277421
vkiridana@yahoo.co.uk
Contact Person for Public Queries
Dr V. Kiridana
Consultant Paediatrician
14/2, Deveni Rajasingha Mawatha, Gatambe, Kandy
0772277421
vkiridana@yahoo.co.uk
Primary study sponsor/organization
GH Vavuniya
Vavuniya
0242222761
0242222262
msghvav@yahoo.ca
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
