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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
SLCTR/2010/001 |
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Date of registration:
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22/01/2010 |
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Primary sponsor: |
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Public title:
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Comparison of two antibiotics in the treatment of typhoid fever in children in General Hospital, Vavuniya
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Scientific title:
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Treatment of children with Typhoid fever: a comparative trial of Cotrimoxazole and Ampicillin in General Hospital Vavuniya. |
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Date of first enrolment:
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12/12/2009 |
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Target sample size:
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124 (62 in each group) |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={0D6FCADD-1079-4F06-B370-1D0B6E88280B} |
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Study type:
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Interventional |
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Study design:
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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)
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr V. Kiridana
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Address:
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14/2, Deveni Rajasingha Mawatha, Gatambe, Kandy
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Telephone:
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0772277421 |
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Email:
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vkiridana@yahoo.co.uk |
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Affiliation:
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Consultant Paediatrician |
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Name:
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Dr V. Kiridana
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Address:
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14/2, Deveni Rajasingha Mawatha, Gatambe, Kandy
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Telephone:
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0772277421 |
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Email:
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vkiridana@yahoo.co.uk |
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Affiliation:
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Consultant Paediatrician |
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Key inclusion & exclusion criteria
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Inclusion criteria: All clinically suspected patients with Typhoid fever
Exclusion criteria: 1. Extremely unwell patients who are unable to tolerate oral fluids
2. Patients with complications of Typhoid fever such as intestinal hemorrhage, intestinal perforation or paralytic ileus
3. Known allergy to Ampicillin or Cotrimoxazole
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Typhoid fever
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Intervention(s)
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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 )
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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1. Development of adverse effects to antibiotics
2. Development of disease related complications
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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none
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