NCT00119132

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,602

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

July 4, 2005

Last Update Submit

January 11, 2017

Conditions

Malaria

Keywords

intermittent preventive treatmenteffectivenessmalaria

Outcome Measures

Primary Outcomes (1)

  • Mean Hb at the end of the high transmission season.

Secondary Outcomes (5)

  • 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

Interventions

artesunate-amodiaquineDRUG
sulphadoxine-pyrimethamineDRUG

Eligibility Criteria

Age3 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic illness
  • History of hypersensitivity to any of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministry of Health, Hohoe district hospital

Hohoe, Volta Region, Ghana

Location

Related Publications (4)

  • Patouillard E, Conteh L, Webster J, Kweku M, Chandramohan D, Greenwood B. Coverage, adherence and costs of intermittent preventive treatment of malaria in children employing different delivery strategies in Jasikan, Ghana. PLoS One. 2011;6(11):e24871. doi: 10.1371/journal.pone.0024871. Epub 2011 Nov 3.

    PMID: 22073137DERIVED

  • Conteh L, Patouillard E, Kweku M, Legood R, Greenwood B, Chandramohan D. Cost effectiveness of seasonal intermittent preventive treatment using amodiaquine & artesunate or sulphadoxine-pyrimethamine in Ghanaian children. PLoS One. 2010 Aug 17;5(8):e12223. doi: 10.1371/journal.pone.0012223.

    PMID: 20808923DERIVED

  • Kweku M, Webster J, Adjuik M, Abudey S, Greenwood B, Chandramohan D. Options for the delivery of intermittent preventive treatment for malaria to children: a community randomised trial. PLoS One. 2009 Sep 30;4(9):e7256. doi: 10.1371/journal.pone.0007256.

    PMID: 19789648DERIVED

  • Kweku M, Liu D, Adjuik M, Binka F, Seidu M, Greenwood B, Chandramohan D. Seasonal intermittent preventive treatment for the prevention of anaemia and malaria in Ghanaian children: a randomized, placebo controlled trial. PLoS One. 2008;3(12):e4000. doi: 10.1371/journal.pone.0004000. Epub 2008 Dec 22.

    PMID: 19098989DERIVED

MeSH Terms

Conditions

Malaria

Interventions

amodiaquine, artesunate drug combinationfanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2005

First Posted

July 13, 2005

Study Start

June 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

GH(1)