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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: |
PACTR201211000449232 |
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Date of registration:
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01/11/2012 |
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Primary sponsor: |
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Public title:
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Intermittent Preventive Treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine in schoolchildren.
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Scientific title:
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Intermittent Preventive Treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine in schoolchildren of the Democratic Republic of Congo. A Randomised Control Trial. |
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Date of first enrolment:
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2012-11-12 |
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Target sample size:
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1100 |
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Recruitment status: |
Not yet recruiting |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201211000449232 |
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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,
Permuted block randomisation (block of three with variable block size) using a randomisation table created by a computer software program,
Allocation was determined by the holder of the sequence who is situated off site,
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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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Joachim
Doua |
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Address:
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Universiteitplein
2610
Antwerp-Wilrijk
Belgium |
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Telephone:
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003232652874 |
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Email:
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joachimy.doua@ua.ac.be |
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Affiliation:
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International Health Unit, University of Antwerp |
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Name:
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Joachim
Doua |
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Address:
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Universiteitplein
2610
Wilrijk-Antwerp
Belgium |
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Telephone:
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003232652874 |
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Email:
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joachimy.doua@ua.ac.be |
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Affiliation:
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International Health Unit, University of Antwerp |
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Key inclusion & exclusion criteria
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Inclusion criteria: - males and females primary school children,
anticipated local residence for the study duration,
signed or thumb-printed informed consent by the parents or guardians and witnessed by an impartial witness (whenever parents/guardians are illiterate)
informed ascent for 12-year children or more
Exclusion criteria: Children of the 6th primary school year
Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
Known hypersensitivity or serious adverse events (AE) to study drugs.
Clinical malaria at baseline irrespectively of the severity (World Health Organisation malaria treatment guideline 2010) (Annex III).
Febrile conditions caused by diseases other than malaria at first visit.
Clinical symptoms of severe anaemia
Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and sickle cell.
Body weight ` 14 Kg
Children with major chronic infectious diseases.
Age minimum:
5 Year
Age maximum:
15 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Malaria
null
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Primary Outcome(s)
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Hemoglobin concentration
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Secondary Outcome(s)
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Educational performance
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malaria incidence
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malaria parasitemia
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Malaria prevalence
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Prevalence of P. falciparum dihydrofolate reductase and dihydropteroate synthase markers
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Rate of malnutrition
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School attendance
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Secondary ID(s)
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B300201214729
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ESP/CE/045/2012
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NCT01722539
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Source(s) of Monetary Support
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Fonds Wetenschappelijk Onderzoek
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