Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201101000273931 Date of Approval: 14/01/2011
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Isoniazid or Rifampicin and Isoniazid Preventive Therapy for children exposed to TB - the IRIPT trial
Official scientific title Isoniazid or Rifampicin and Isoniazid Preventive Therapy for children exposed to TB - the IRIPT trial
Brief summary describing the background and objectives of the trial Children<5 years of age exposed to TB at home, should receive Isoniazid Preventie Thearpy (IPT) according to WHO guidelines. An earlier study implemented 9 months IPT for exposed children in Bissau, but only 50% completed 6 months of continuous treatment. In the IRIPT study, we will compare 9 months of Isoniazid with 4 months of Rifampicin and Isoniazid, with adherence to therapy as primary endpoint. We also want to assess the mortality related to TB and TB exposure among children<15 in Bissau.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) IRIPT
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Prevention
Anticipated trial start date 18/01/2011
Actual trial start date 18/01/2011
Anticipated date of last follow up 14/11/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 880
Actual target sample size (number of participants) 752
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Isoniazid 10-15 mg/kg/day, max dosage 300 mg/day 9 months Isoniazid 100 mg pills are given in the dosage and duration described, to TB contacts < 15 years of age as TB preventive therapy. 440 Active-Treatment of Control Group
Experimental Group Rifampicin and Isoniazid RIF 15-20 mg/kg/day, max dosage 600 mg; Isoniazid 7,5-10 mg/kg/day, max dosage 300 mg 4 months Rifampicin/Isonaizid 150mg/75mg fixed combination pills are given in the dosage and duration described, to TB contacts < 15 years of age, as TB preventive therapy 440 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1)Household contact of TB case 2)Age<5 years or age 5-14 years + a positive TST (>5mm) 3)Informed consent given by parent or person in loco parentis 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 girls>12 years will get a pregnancy test) 5)A history of seizures 0 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/11/2010 Comite Nacional de Etica na Saude
Ethics Committee Address
Street address City Postal code Country
Instituto Nacional de Saude Publica, Avenida Combatente da Liberdade de Patria, Hospital "3 de Agosto", Apartado 861 Bissau 1004 Guinea-Bisseu
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence to therapy (80% of pills taken will be considered good adherence) Every two weeks (pill count performed)
Secondary Outcome Mortality Every two weeks 1 month after inclusion 4 months after inclusion 9 months after inclusion 24 months after inclusion
Secondary Outcome TB incidence Every two weeks 1 month after inclusion 4 months after inclusion 9 months after inclusion 24 months after inclusion
Secondary Outcome TST conversion 9 months after inclusion
Secondary Outcome Adverse events Every two weeks 1 month after inclusion 4 months after inclusion 9 months after inclusion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Projecto de Saude de Bandim Apartado 861 Bissau 1004 Guinea-Bisseu
FUNDING SOURCES
Name of source Street address City Postal code Country
EDCTP Laan van Nieuw Oost Indië 334 The Hague Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Christian Wejse Department of Infectious Diseases, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100 Aarhus 8200 Denmark Hospital
COLLABORATORS
Name Street address City Postal code Country
Victor Fransisco Gomes Apartado 861 Bissau 1004 Guinea-Bisseu
Jens Erik Vejrum Department of Pediatrics, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100 Aarhus 8200 Denmark
Grethe Lemvik Apartado 861 Bissau 1004 Guinea-Bisseu
Lars Jørgen Østergaard Department of Infectious diseases, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100 Aarhus 8200 Denmark
Victor Fransisco Gomes Apartado 861 Bissau 1004 Guinea-Bisseu
Jens Erik Vejrum Department of Pediatrics, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100 Aarhus 8200 Denmark
Grethe Lemvik Apartado 861 Bissau 1004 Guinea-Bisseu
Lars Jørgen Østergaard Department of Infectious diseases, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100 Aarhus 8200 Denmark
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Grethe Lemvik grethe.lemvik@ki.au.dk +245 6751431 Apartado 861
City Postal code Country Position/Affiliation
Bissau 1004 Guinea-Bisseu PhD student, Bandim Health Project/Statens Serum Institut
Role Name Email Phone Street address
Public Enquiries Grethe Lemvik grethe.lemvik@ki.au.dk +245 6751431 Apartado 861
City Postal code Country Position/Affiliation
Bissau 1004 Guinea-Bisseu PhD student, Bandim Health Project/Statens Serum Institut
Role Name Email Phone Street address
Scientific Enquiries Christian Wejse wejse@dadlnet.dk +45 86106825 Department of Infectious Diseases, Aarhus University Hospital, Brendstrupgaardsvej 100
City Postal code Country Position/Affiliation
Aarhus 8200 Denmark MD, PhD, Department of Infectious Diseases, Aarhus University Hospital / Bandim Health Project
REPORTING
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