Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana (ACTIPT)
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|ClinicalTrials.gov Identifier: NCT01459146|
Recruitment Status : Unknown
Verified October 2011 by Dr. Ernest Cudjoe Opoku M.D., M.P.H., Navrongo Health Research Centre, Ghana.
Recruitment status was: Recruiting
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Malaria Schistosomiasis Helminthiasis Anemia Change in Sustained Attention||Drug: Artemether-lumefantrine combination plus albendazole Drug: Artemether-lumefantrine plus Praziquantel plus Albendazole Drug: Albendazole plus Praziquantel||Phase 4|
Introduction: Malaria, schistosomiasis and soil-transmitted helminth (STH) infections are rife in sub-Saharan Africa where school children are at great risk of morbidity. Although the strategy of using intermittent preventive treatment (IPT) for malaria control has been proven beneficial among infants and pregnant women, it is yet to be implemented in school children on a large scale. Sulfadoxine-pyrimethamine (SP) use as IPT is being limited by widespread reports of resistance. Artemisinin-based combination therapy (ACT) has been proven efficacious as IPT among school children in few studies. Other studies have shown that artemisinin derivatives exhibit anti-schistosomal activity. This could be an added effect of using ACTs, as IPT, to prevent malaria related morbidity in school children in sub-Saharan Africa.
General Objective: To examine the effect of IPT with ACTs and anti-helminthes against malaria and helminthes infections on health and school attention among children 6 to 12 years old.
- To estimate the prevalence of malaria parasitemia, schistosomiasis and anemia among primary schoolchildren.
- To determine the impact of 3 doses of IPT (with artemether-lumefantrine) and de-worming (with albendazole and/or praziquantel) on hemoglobin and school (classroom) attention and recall.
- To determine the effects of IPT (with artemether-lumefantrine) and de-worming (with albendazole and /or praziquantel) on the prevalence and intensity of schistosomes infection among schoolchildren.
- To determine the safety and tolerability of IPT with artemether-lumefantrine combined with albendazole and/or praziquantel among school children.
Materials and methods: An open-labeled randomized trial, including 3 arms, will be carried out in 6 primary schools in the Kassena-Nankana Districts, Ghana, where malaria and schistosome infection (with S. hematobium and S. mansoni) are endemic. After informed consent and assent are obtained, about 345 (115 in each arm) class three school children will be investigated for malaria parasitemia, anemia, schistosome and soil-transmitted helminths infections, and classroom attention and recall in a baseline pre-intervention survey. Mass treatment is then carried out in the 6 randomized schools with ACT and albendazole in one study arm; ACT, albendazole and praziquantel in the second arm while albendazole and praziquantel will be given in the third school arm. ACT mass treatment using artemether-lumefantrine is carried out every school term (4 monthly) for one year while praziquantel is given once and albendazole twice a year. After one academic year, the same 345 (115 in each arm) selected participants in class three are assessed for hemoglobin, malaria parasitemia, STH and schistosome infections and classroom attention and recall. Safety and tolerability of the combined IPT is assessed at 28 days post treatment.
Data analysis- Data will be analyzed by both intention-to-treat and per-protocol employing uni-variate and multivariate logistic regression analysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||345 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||November 2012|
Experimental: AL plus ABZ; Arm 1
Artemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral
Drug: Artemether-lumefantrine combination plus albendazole
AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat
Active Comparator: AL plus PZQ plus ABZ; Arm 2
artemether-lumefantrine combination 120mg/20mg 12 hourly for 3 days; plus praziquantel 40mg/kg stat; plus albendazole 400mg stat oral
Drug: Artemether-lumefantrine plus Praziquantel plus Albendazole
Artemether-lumefantrine 20mg/120mg 12 hourly for 3 days, plus praziquantel 40mg/kg stat, plus albendazole 400mg stat oral
Active Comparator: ABZ plus PZQ; Arm 3
Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
Drug: Albendazole plus Praziquantel
Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
- Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy [ Time Frame: Day 28 post intervention ]Change from baseline of prevalence and density of malaria parasitemia 28 days post interventions
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Day 365 ]Number of reported adverse events within twelve months of intervention per study arm
- Number of schoolchildren with sustained attention and recall as a measure of efficacy [ Time Frame: Day 365 ]Change in sustained classroom attention and recall in 365 days of start of intervention from baseline
- Proportion of schoolchildren with anemia as a measure of safety and tolerability [ Time Frame: Day 365 ]Proportion of schoolchildren having hemoglobin level less than 12.0g/dl from baseline level in 365 days of start of intervention
- Prevalence and intensity of urinary schistosomiasis as a measure of efficacy [ Time Frame: 365 days post first intervention ]Proportion of schoolchildren with urinary schistosomiasis by study arm compared to baseline
- Prevalence and density of malaria parasites by microscopy as a measure of efficacy [ Time Frame: 365 days ]Proportion of schoolchildren with malaria parasitemia by study arm compared to baseline
- Prevalence and intensity of intestinal schistosomiasis among schoolchildren as a measure of efficacy [ Time Frame: 365 days ]Proportion of schoolchildren with intestinal schistosomiasis by study arm compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459146
|Contact: Ernest C Opoku, MD, MPH||+233 244 firstname.lastname@example.org|
|Contact: Abraham V Hodgson, MD, MPH, PhD||+233 244 577665||AHodgson@navrongo.mimcom.net|
|Contact: Ernest C Opoku, MD, MPH +233 244 734608 email@example.com|
|Contact: Abraham V Hodgson, MD, MPH, PhD +233 244 577665 AHodgson@navrongo.mimcom.net|
|Principal Investigator:||Ernest C Opoku, MD, MPH||Navrongo Health Research Centre, Ghana|
|Principal Investigator:||Pascal Magnussen, MD||University of Copenhagen|
|Study Director:||Abraham V Hodgson, MD, MPH, PhD||Navrongo Health Research Centre, Ghana|
|Principal Investigator:||Edmund L Browne, MD, MPH, PhD||University of Development Studies|
|Principal Investigator:||Annette Olsen, PhD||University of Copenhagen|