NCT00738946

Brief Summary

An investigation will be made of the combined impact of insecticide-treated nets and intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during the malaria season in one year and the follow-up will be extended into the second year by passive surveillance.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
2 countries

2 active sites

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

August 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 4, 2010

Status Verified

June 1, 2010

Enrollment Period

4 months

First QC Date

August 20, 2008

Last Update Submit

June 3, 2010

Conditions

Malaria

Keywords

Intermittent Preventive treatmentinsecticide treated bednetsmalaria

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinical malaria

    2008-2009

Secondary Outcomes (1)

  • Incidence of severe malaria, Incidence of anemia, Prevalence of anemia, Prevalence of parasitemia, Proportion of children with parasites carrying resistance markers to AQ and SP, Incidence of hospital admissions due to malaria.

    2008-2009

Study Arms (1)

2

EXPERIMENTAL

Amodiaquine+pyrimethamine versus placebo

Drug: Intermittent preventive treatment with AQ+ SP

Interventions

Intermittent preventive treatment with AQ+ SPDRUG

Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval

Also known as: IPTc
2

Eligibility Criteria

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

You may qualify if:

  • Permanent residence in the study area with no intention of leaving during the surveillance period.
  • Obtention of informed consent.

You may not qualify if:

  • Temporary residence in the study area.
  • Absence of informed consent.
  • Presence of a severe, chronic illness such as severe malnutrition (Kwashiorkor or marasmus) or AIDS, likely to interfere with evaluation of the trial results.
  • A history of a previous, significant adverse reaction to either of the study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre National de Recherche et de Formation sur le Paludisme

Ouagadougou, Kadiogo, BP 2208, Burkina Faso

Location

Malaria Research and Training Centre

Bamako, Mali

Location

Related Publications (4)

  • Konate AT, Yaro JB, Ouedraogo AZ, Diarra A, Gansane A, Soulama I, Kangoye DT, Kabore Y, Ouedraogo E, Ouedraogo A, Tiono AB, Ouedraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood BM, Diallo DA. Morbidity from malaria in children in the year after they had received intermittent preventive treatment of malaria: a randomised trial. PLoS One. 2011;6(8):e23391. doi: 10.1371/journal.pone.0023391. Epub 2011 Aug 12.

    PMID: 21858097DERIVED

  • Dicko A, Barry A, Dicko M, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Conare T, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Malaria morbidity in children in the year after they had received intermittent preventive treatment of malaria in Mali: a randomized control trial. PLoS One. 2011;6(8):e23390. doi: 10.1371/journal.pone.0023390. Epub 2011 Aug 12.

    PMID: 21858096DERIVED

  • Konate AT, Yaro JB, Ouedraogo AZ, Diarra A, Gansane A, Soulama I, Kangoye DT, Kabore Y, Ouedraogo E, Ouedraogo A, Tiono AB, Ouedraogo IN, Chandramohan D, Cousens S, Milligan PJ, Sirima SB, Greenwood B, Diallo DA. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Burkina Faso: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000408. doi: 10.1371/journal.pmed.1000408.

    PMID: 21304925DERIVED

  • Dicko A, Diallo AI, Tembine I, Dicko Y, Dara N, Sidibe Y, Santara G, Diawara H, Conare T, Djimde A, Chandramohan D, Cousens S, Milligan PJ, Diallo DA, Doumbo OK, Greenwood B. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Mali: a randomised, double-blind, placebo-controlled trial. PLoS Med. 2011 Feb 1;8(2):e1000407. doi: 10.1371/journal.pmed.1000407.

    PMID: 21304923DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Brian M Greenwood, MD, FRCP

    London School of Hygiene and Tropical Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

June 4, 2010

Record last verified: 2010-06

Locations

MA(1)BU(1)