ACTIPT
The Impact of Intermittent Preventive Malaria Treatment With Artemisinin Combination Therapy (ACT) on Hemoglobin, Malaria, Schistosomiasis, and School Attention Among Primary Schoolchildren in the Kassena-Nankana Districts, Ghana
Sponsor study identifier
interventional
345
1 country
1
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine if Artemisinin-based Combination Therapy, ACT,(artemether-lumefantrine) used as intermittent preventive treatment (IPT) alone or in combination with praziquantel, will have any effects on anemia, malaria, schistosomiasis and school sustained attention and concentration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 17, 2011
Actual (reported)October 25, 2011
Actual (reported)November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy
Change from baseline of prevalence and density of malaria parasitemia 28 days post interventions
Day 28 post intervention
Number of participants with adverse events as a measure of safety and tolerability
Day 365
Number of schoolchildren with sustained attention and recall as a measure of efficacy
Day 365
Artemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral
artemether-lumefantrine combination 120mg/20mg 12 hourly for 3 days; plus praziquantel 40mg/kg stat; plus albendazole 400mg stat oral
Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat
Artemether-lumefantrine 20mg/120mg 12 hourly for 3 days, plus praziquantel 40mg/kg stat, plus albendazole 400mg stat oral
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Artemether-lumefantrine combination plus albendazole
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Artemether-lumefantrine plus Praziquantel plus Albendazole
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Albendazole plus Praziquantel
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNHRC
Navrongo, Ghana
Ernest C Opoku, MD, MPH
Navrongo Health Research Centre, Ghana
Pascal Magnussen, MD
University of Copenhagen
Abraham V Hodgson, MD, MPH, PhD
Navrongo Health Research Centre, Ghana
Edmund L Browne, MD, MPH, PhD
University of Development Studies
First Submitted
October 17, 2011
First Posted
October 25, 2011
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Estimated (date passed)Proportion of schoolchildren with anemia as a measure of safety and tolerability
Day 365
Prevalence and intensity of urinary schistosomiasis as a measure of efficacy
365 days post first intervention
Prevalence and density of malaria parasites by microscopy as a measure of efficacy
365 days
Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Annette Olsen, PhD
University of Copenhagen
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 25, 2011
Record last verified: 2011-10
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Source: ClinicalTrials.gov.
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