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

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Brief Title

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

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy

Secondary Outcome

 Number of participants with adverse events as a measure of safety and tolerability

Condition

Malaria

Intervention

Artemether-lumefantrine combination plus albendazole

Study Arms / Comparison Groups

 AL plus ABZ; Arm 1
Description:  Artemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

345

Start Date

December 2010

Completion Date

November 2012

Primary Completion Date

October 2011

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
      

Gender

All

Ages

6 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Ernest C Opoku, MD, MPH, +233 244 734608, [email protected]

Location Countries

Ghana

Location Countries

Ghana

Administrative Informations


NCT ID

NCT01459146

Organization ID

NHRCIRB098


Responsible Party

Principal Investigator

Study Sponsor

Navrongo Health Research Centre, Ghana

Collaborators

 DBL -Institute for Health Research and Development

Study Sponsor

Ernest C Opoku, MD, MPH, Principal Investigator, Navrongo Health Research Centre, Ghana


Verification Date

October 2011