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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Navrongo Health Research Centre, Ghana.
Recruitment status was  Recruiting
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
ClinicalTrials.gov Identifier:
NCT01459146
First received: October 17, 2011
Last updated: October 22, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Malaria
Schistosomiasis
Helminthiasis
Anemia
Change in Sustained Attention
Drug: Artemether-lumefantrine combination plus albendazole
Drug: Artemether-lumefantrine plus Praziquantel plus Albendazole
Drug: Albendazole plus Praziquantel
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Navrongo Health Research Centre, Ghana:

Primary Outcome Measures:
  • Prevalence and density of malaria parasites, determined by microscopy, as a measure of efficacy [ Time Frame: Day 28 post intervention ] [ Designated as safety issue: No ]
    Change from baseline of prevalence and density of malaria parasitemia 28 days post interventions


Secondary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Day 365 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Proportion of schoolchildren with intestinal schistosomiasis by study arm compared to baseline


Estimated Enrollment: 345
Study Start Date: December 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL plus ABZ; Arm 1
Artemether-Lumefantrine combination 20mg/120mg 12 hourly for 3 days oral, plus albendazole 400mg stat oral
Drug: Artemether-lumefantrine combination plus albendazole
AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat
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
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
Active Comparator: ABZ plus PZQ; Arm 3
Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
Drug: Albendazole plus Praziquantel
Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral

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

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459146

Contacts
Contact: Ernest C Opoku, MD, MPH +233 244 734608 erniecudjoe@yahoo.com
Contact: Abraham V Hodgson, MD, MPH, PhD +233 244 577665 AHodgson@navrongo.mimcom.net

Locations
Ghana
NHRC Recruiting
Navrongo, Ghana
Contact: Ernest C Opoku, MD, MPH    +233 244 734608    erniecudjoe@yahoo.com   
Contact: Abraham V Hodgson, MD, MPH, PhD    +233 244 577665    AHodgson@navrongo.mimcom.net   
Sponsors and Collaborators
Navrongo Health Research Centre, Ghana
DBL -Institute for Health Research and Development
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. Ernest Cudjoe Opoku M.D., M.P.H., M.D., M.P.H., Navrongo Health Research Centre, Ghana
ClinicalTrials.gov Identifier: NCT01459146     History of Changes
Other Study ID Numbers: NHRCIRB098
Study First Received: October 17, 2011
Last Updated: October 22, 2011
Health Authority: Ghana: Ministry of Health

Keywords provided by Navrongo Health Research Centre, Ghana:
IPT
malaria
ACT
schistosomiasis
Hemoglobin
Anemia
Sustained attention
Recall
Schoolchildren
Kassena-Nankana

Additional relevant MeSH terms:
Malaria
Schistosomiasis
Helminthiasis
Protozoan Infections
Parasitic Diseases
Trematode Infections
Lumefantrine
Artemether
Artemisinins
Artemether-lumefantrine combination
Albendazole
Praziquantel
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Anticestodal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014