NCT01459146

Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 345 (estimated)
• Sponsor: Navrongo Health Research Centre, Ghana · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Specific objectives 1. To estimate the prevalence of malaria parasitemia, schistosomiasis and anemia among primary schoolchildren. 2. 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. 3. 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. 4. 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.

Conditions

• Malaria
• Schistosomiasis
• Helminthiasis
• Anemia
• Change in Sustained Attention

Interventions

Type	Name	Description
DRUG	Artemether-lumefantrine combination plus albendazole	AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat
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
DRUG	Albendazole plus Praziquantel	Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-10-01
• Completion: 2012-11-01
• First posted: 2011-10-25
• Last updated: 2011-10-25

Locations

1 site across 1 country: Ghana