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Effectiveness of Intermittent Preventive Treatment for Malaria in Children

This study has been completed.
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine Identifier:
First received: July 4, 2005
Last updated: January 11, 2017
Last verified: January 2017
Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.

Condition Intervention Phase
Drug: artesunate-amodiaquine
Drug: sulphadoxine-pyrimethamine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana

Resource links provided by NLM:

Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Mean Hb at the end of the high transmission season.

Secondary Outcome Measures:
  • Incidence of moderate (Hb<8.0g/dl>5.0g/dl) and severe anaemia (Hb<5.0g/dl) during the period of the intervention
  • Incidence of severe and clinical malaria during the period of the intervention
  • Prevalence of anaemia at the post intervention survey
  • Prevalence of parasitaemia and gametocytemia at the post intervention survey
  • Prevalence of molecular markers of resistance to SP among children who have malaria at the post intervention survey

Enrollment: 2602
Study Start Date: June 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   3 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Children between the ages of 3-59 months resident in the selected communities
  • Children likely to be available for follow-up for 18 months
  • Consent by parent/guardian of child

Exclusion Criteria:

  • Chronic illness
  • History of hypersensitivity to any of the study drugs
  Contacts and Locations
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Please refer to this study by its identifier: NCT00119132

Ministry of Health, Hohoe district hospital
Hohoe, Volta region, Ghana
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Principal Investigator: Margaret Kweku, MBChB, MPH London School of Hygiene and Tropical Medicine
Principal Investigator: Daniel Chandramohan, MBBS, PhD London School of Hygiene and Tropical Medicine
Principal Investigator: Brian Greenwood, FRCP, FRS London School of Hygiene and Tropical Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine Identifier: NCT00119132     History of Changes
Other Study ID Numbers: ITCR5098
Study First Received: July 4, 2005
Last Updated: January 11, 2017

Keywords provided by London School of Hygiene and Tropical Medicine:
intermittent preventive treatment

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides processed this record on April 28, 2017