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

NCT01459146 | Unknown Phase 4 DMC

• 1 other identifier: NHRCIRB098
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

IPT; malaria; ACT; schistosomiasis; Hemoglobin; Anemia; Sustained attention; Recall; Schoolchildren; Kassena-Nankana

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

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

  Day 365

• Number of schoolchildren with sustained attention and recall as a measure of efficacy

  Day 365

• Proportion of schoolchildren with anemia as a measure of safety and tolerability

  Day 365

• Prevalence and intensity of urinary schistosomiasis as a measure of efficacy

  365 days post first intervention

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

  365 days

Study Arms (3)

AL plus ABZ; Arm 1

EXPERIMENTAL

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

Drug: Artemether-lumefantrine combination plus albendazole

AL plus PZQ plus ABZ; Arm 2

ACTIVE COMPARATOR

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

ABZ plus PZQ; Arm 3

ACTIVE COMPARATOR

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

Drug: Albendazole plus Praziquantel

Interventions

Artemether-lumefantrine combination plus albendazole DRUG

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

AL plus ABZ; Arm 1

Artemether-lumefantrine plus Praziquantel plus Albendazole DRUG

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

AL plus PZQ plus ABZ; Arm 2

Albendazole plus Praziquantel DRUG

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

ABZ plus PZQ; Arm 3

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parental informed consent and assent by schoolchildren
• No known history of allergy to any study drug
• Aged 6 or more years

You may not qualify if:

• lack of parental informed consent and assent by schoolchildren
• Known allergy or history of allergy to any study drug
• Aged less than 6 years

Sponsors & Collaborators

• Navrongo Health Research Centre, Ghana: lead
• DBL -Institute for Health Research and Development: collaborator

Study Sites (1)

NHRC

Navrongo, Ghana

RECRUITING

MeSH Terms

Conditions

Malaria; Schistosomiasis; Helminthiasis; Anemia

Interventions

Artemether, Lumefantrine Drug Combination; Albendazole; Praziquantel

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Trematode Infections; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Carbamates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Isoquinolines

Study Officials

• Ernest C Opoku, MD, MPH

  Navrongo Health Research Centre, Ghana

  PRINCIPAL INVESTIGATOR

• Pascal Magnussen, MD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Abraham V Hodgson, MD, MPH, PhD

  Navrongo Health Research Centre, Ghana

  STUDY DIRECTOR

• Edmund L Browne, MD, MPH, PhD

  University of Development Studies

  PRINCIPAL INVESTIGATOR

• Annette Olsen, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernest C Opoku, MD, MPH

CONTACT

+233 244 734608; erniecudjoe@yahoo.com

Abraham V Hodgson, MD, MPH, PhD

CONTACT

+233 244 577665; AHodgson@navrongo.mimcom.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., M.P.H.

Study Record Dates

• First Submitted: October 17, 2011
• First Posted: October 25, 2011
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2012
• Last Updated: October 25, 2011

Record last verified: 2011-10

Locations

GH (1)