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

NCT ID: NCT01459146

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-11-30

Brief Summary

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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

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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

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Malaria Schistosomiasis Helminthiasis Anemia Change in Sustained Attention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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AL plus ABZ; Arm 1

Artemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral

Group Type EXPERIMENTAL

Artemether-lumefantrine combination plus albendazole

Intervention Type DRUG

AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat

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

Group Type ACTIVE_COMPARATOR

Artemether-lumefantrine plus Praziquantel plus Albendazole

Intervention Type DRUG

Artemether-lumefantrine 20mg/120mg 12 hourly for 3 days, plus praziquantel 40mg/kg stat, plus albendazole 400mg stat oral

ABZ plus PZQ; Arm 3

Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral

Group Type ACTIVE_COMPARATOR

Albendazole plus Praziquantel

Intervention Type DRUG

Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral

Interventions

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Artemether-lumefantrine combination plus albendazole

AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat

Intervention Type 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

Intervention Type DRUG

Albendazole plus Praziquantel

Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DBL -Institute for Health Research and Development

OTHER

Sponsor Role collaborator

Navrongo Health Research Centre, Ghana

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ernest Cudjoe Opoku M.D., M.P.H.

M.D., M.P.H.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ernest C Opoku, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Navrongo Health Research Centre, Ghana

Pascal Magnussen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Abraham V Hodgson, MD, MPH, PhD

Role: STUDY_DIRECTOR

Navrongo Health Research Centre, Ghana

Edmund L Browne, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Development Studies

Annette Olsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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NHRC

Navrongo, , Ghana

Site Status RECRUITING

Countries

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Ghana

Central Contacts

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Ernest C Opoku, MD, MPH

Role: CONTACT

[email protected]
+233 244 734608

Abraham V Hodgson, MD, MPH, PhD

Role: CONTACT

[email protected]
+233 244 577665

Facility Contacts

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Ernest C Opoku, MD, MPH

Role: primary

[email protected]
+233 244 734608

Abraham V Hodgson, MD, MPH, PhD

Role: backup

[email protected]
+233 244 577665

Other Identifiers

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NHRCIRB098

Identifier Type: -

Identifier Source: org_study_id