Effectiveness of Intermittent Preventive Treatment for Malaria in Children

This study has been completed.
Sponsor:
Collaborator:
INDEPTH Network
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00119132
First received: July 4, 2005
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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
Malaria
Drug: artesunate-amodiaquine
Drug: sulphadoxine-pyrimethamine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Gates Malaria Partnership:

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

  Eligibility

Ages Eligible for Study:   3 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT00119132

Locations
Ghana
Ministry of Health, Hohoe district hospital
Hohoe, Volta region, Ghana
Sponsors and Collaborators
Gates Malaria Partnership
INDEPTH Network
Investigators
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

No publications provided by Gates Malaria Partnership

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daniel Chandramohan, London School of Hygiene & Tropical Medicine
ClinicalTrials.gov Identifier: NCT00119132     History of Changes
Other Study ID Numbers: ITCR5098
Study First Received: July 4, 2005
Last Updated: January 14, 2009
Health Authority: Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:
intermittent preventive treatment
effectiveness
malaria

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Pyrimethamine
Sulfadoxine
Artesunate
Sulfadoxine-pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Amebicides

ClinicalTrials.gov processed this record on July 20, 2014