Clinical trial NCT01459146: Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria
Schistosomiasis
Helminthiasis
Anemia
Change in Sustained Attention
Keywords: IPT
malaria
ACT
schistosomiasis
Hemoglobin
Anemia
Sustained attention
Recall
Schoolchildren
Kassena-Nankana
Lead sponsor: Navrongo Health Research Centre, Ghana
Sponsor class: OTHER
Collaborators: name: DBL -Institute for Health Research and Development
First posted: 2011-10-25
Enrollment: 345
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Parental informed consent and assent by schoolchildren
* No known history of allergy to any study drug
* Aged 6 or more years

Exclusion Criteria:

* lack of parental informed consent and assent by schoolchildren
* Known allergy or history of allergy to any study drug
* Aged less than 6 years

Primary outcomes:
measure: Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy
timeFrame: Day 28 post intervention
Secondary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: Day 365
measure: Number of schoolchildren with sustained attention and recall as a measure of efficacy
timeFrame: Day 365
measure: Proportion of schoolchildren with anemia as a measure of safety and tolerability
timeFrame: Day 365
measure: Prevalence and intensity of urinary schistosomiasis as a measure of efficacy
timeFrame: 365 days post first intervention
measure: Prevalence and density of malaria parasites by microscopy as a measure of efficacy
timeFrame: 365 days
measure: Prevalence and intensity of intestinal schistosomiasis among schoolchildren as a measure of efficacy
timeFrame: 365 days
Other outcomes:
Locations:
city: Navrongo
country: Ghana
facility: NHRC
Study officials:
affiliation: Navrongo Health Research Centre, Ghana
name: Ernest C Opoku, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Pascal Magnussen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Navrongo Health Research Centre, Ghana
name: Abraham V Hodgson, MD, MPH, PhD
role: STUDY_DIRECTOR
affiliation: University of Development Studies
name: Edmund L Browne, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Annette Olsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: