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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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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201101000273931 |
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Date of registration:
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14/01/2011 |
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Primary sponsor: |
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Public title:
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Isoniazid or Rifampicin and Isoniazid Preventive Therapy for children exposed to TB - the IRIPT trial
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Scientific title:
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Isoniazid or Rifampicin and Isoniazid Preventive Therapy for children exposed to TB - the IRIPT trial |
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Date of first enrolment:
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2011-01-18 |
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Target sample size:
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880 |
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Recruitment status: |
Open to recruitment: actively recruiting participa |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201101000273931 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using a randomisation table created by a computer software program. Cluster randomised by house, 220 clusters with a mean of 4 children per house to be included,
Sealed opaque envelopes,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Grethe
Lemvik |
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Address:
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Apartado 861
1004
Bissau
Guinea-Bisseu |
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Telephone:
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+245 6751431 |
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Email:
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grethe.lemvik@ki.au.dk |
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Affiliation:
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PhD student, Bandim Health Project/Statens Serum Institut |
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Name:
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Christian
Wejse |
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Address:
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Department of Infectious Diseases, Aarhus University Hospital, Brendstrupgaardsvej 100
8200
Aarhus
Denmark |
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Telephone:
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+45 86106825 |
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Email:
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wejse@dadlnet.dk |
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Affiliation:
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MD, PhD, Department of Infectious Diseases, Aarhus University Hospital / Bandim Health Project |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1)Household contact of TB case
2)Age`5 years or
age 5-14 years + a positive TST (b5mm)
3)Informed consent given by parent or person in loco parentis
Exclusion criteria: 1)Active TB at time of inclusion
2)HIV-positive child receiving HAART
3)Known liver disease or allergy to INH or RIF
4)Pregnancy (all girlsb12 years will get a pregnancy test)
5)A history of seizures
Age minimum:
0 Year
Age maximum:
15 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tuberculosis
null
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Primary Outcome(s)
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Adherence to therapy (80% of pills taken will be considered good adherence)
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Secondary Outcome(s)
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Adverse events
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Mortality
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TB incidence
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TST conversion
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Source(s) of Monetary Support
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EDCTP
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