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

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ClinicalTrials.gov Identifier: NCT01459146
Recruitment Status : Unknown
Verified October 2011 by Dr. Ernest Cudjoe Opoku M.D., M.P.H., Navrongo Health Research Centre, Ghana.
Recruitment status was:  Recruiting
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Sponsor:
Collaborator:
DBL -Institute for Health Research and Development
Information provided by (Responsible Party):
Dr. Ernest Cudjoe Opoku M.D., M.P.H., Navrongo Health Research Centre, Ghana

Tracking Information
First Submitted Date  ICMJE October 17, 2011
First Posted Date  ICMJE October 25, 2011
Last Update Posted Date October 25, 2011
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2011)
Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy [ Time Frame: Day 28 post intervention ]
Change from baseline of prevalence and density of malaria parasitemia 28 days post interventions
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2011)
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Day 365 ]
    Number of reported adverse events within twelve months of intervention per study arm
  • Number of schoolchildren with sustained attention and recall as a measure of efficacy [ Time Frame: Day 365 ]
    Change in sustained classroom attention and recall in 365 days of start of intervention from baseline
  • Proportion of schoolchildren with anemia as a measure of safety and tolerability [ Time Frame: Day 365 ]
    Proportion of schoolchildren having hemoglobin level less than 12.0g/dl from baseline level in 365 days of start of intervention
  • Prevalence and intensity of urinary schistosomiasis as a measure of efficacy [ Time Frame: 365 days post first intervention ]
    Proportion of schoolchildren with urinary schistosomiasis by study arm compared to baseline
  • Prevalence and density of malaria parasites by microscopy as a measure of efficacy [ Time Frame: 365 days ]
    Proportion of schoolchildren with malaria parasitemia by study arm compared to baseline
  • Prevalence and intensity of intestinal schistosomiasis among schoolchildren as a measure of efficacy [ Time Frame: 365 days ]
    Proportion of schoolchildren with intestinal schistosomiasis by study arm compared to baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Artemisinin-based Combination Therapy-Intermittent Preventive Treatment (ACT-IPT) Trial Among Schoolchildren in Kassena-Nankana, Ghana
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Malaria
  • Schistosomiasis
  • Helminthiasis
  • Anemia
  • Change in Sustained Attention
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: AL plus ABZ; Arm 1
    Artemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral
    Intervention: Drug: Artemether-lumefantrine combination plus albendazole
  • Active Comparator: 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
    Intervention: Drug: Artemether-lumefantrine plus Praziquantel plus Albendazole
  • Active Comparator: ABZ plus PZQ; Arm 3
    Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
    Intervention: Drug: Albendazole plus Praziquantel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 22, 2011)
345
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2012
Estimated Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ghana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01459146
Other Study ID Numbers  ICMJE NHRCIRB098
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ernest Cudjoe Opoku M.D., M.P.H., Navrongo Health Research Centre, Ghana
Study Sponsor  ICMJE Navrongo Health Research Centre, Ghana
Collaborators  ICMJE DBL -Institute for Health Research and Development
Investigators  ICMJE
Principal Investigator: Ernest C Opoku, MD, MPH Navrongo Health Research Centre, Ghana
Principal Investigator: Pascal Magnussen, MD University of Copenhagen
Study Director: Abraham V Hodgson, MD, MPH, PhD Navrongo Health Research Centre, Ghana
Principal Investigator: Edmund L Browne, MD, MPH, PhD University of Development Studies
Principal Investigator: Annette Olsen, PhD University of Copenhagen
PRS Account Navrongo Health Research Centre, Ghana
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP