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

Anemia Clinical Trial

— ACTIPT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01459146
• Other study ID #: NHRCIRB098
• Status: Recruiting
• Phase: Phase 4
• First received: October 17, 2011
• Last updated: October 22, 2011
• Start date: December 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2011
• Source: Navrongo Health Research Centre, Ghana
• Contact: Ernest C Opoku, MD, MPH
• Phone: +233 244 734608
• Email: erniecudjoe[@]yahoo.com
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 345
• Est. completion date: November 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Ghana	NHRC	Navrongo

Sponsors (2)

Lead Sponsor	Collaborator
Navrongo Health Research Centre, Ghana	DBL -Institute for Health Research and Development

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of participants with adverse events as a measure of safety and tolerability	Number of reported adverse events within twelve months of intervention per study arm	Day 365	Yes
Secondary	Number of schoolchildren with sustained attention and recall as a measure of efficacy	Change in sustained classroom attention and recall in 365 days of start of intervention from baseline	Day 365	No
Secondary	Proportion of schoolchildren with anemia as a measure of safety and tolerability	Proportion of schoolchildren having hemoglobin level less than 12.0g/dl from baseline level in 365 days of start of intervention	Day 365	Yes
Secondary	Prevalence and intensity of urinary schistosomiasis as a measure of efficacy	Proportion of schoolchildren with urinary schistosomiasis by study arm compared to baseline	365 days post first intervention	No
Secondary	Prevalence and density of malaria parasites by microscopy as a measure of efficacy	Proportion of schoolchildren with malaria parasitemia by study arm compared to baseline	365 days	No
Secondary	Prevalence and intensity of intestinal schistosomiasis among schoolchildren as a measure of efficacy	Proportion of schoolchildren with intestinal schistosomiasis by study arm compared to baseline	365 days	No