NCT00111163

Brief Summary

The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,516

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

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

March 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 27, 2012

Status Verified

September 1, 2012

Enrollment Period

2 years

First QC Date

May 17, 2005

Last Update Submit

September 26, 2012

Conditions

MalariaAnemia

Keywords

malariaanemiaPlasmodium falciparuminfantspreventionsafetyefficacyantimalarials

Outcome Measures

Primary Outcomes (1)

  • Clinical malaria in the first year of life

Secondary Outcomes (4)

  • Moderate and severe anemia in the first year of life

  • Serologic responses to Expanded Program on Immunization (EPI) vaccines (Polio, Diphtheria, Tetanus, Pertussis, Hepatitis B, Hemophilus Influenzae type B, and Measles)

  • Nasal carriage rates of Haemophilus influenza type b

  • All cause hospitalization in the first year of life

Interventions

sulfadoxine-pyrimethamine with artesunateDRUG
amodiaquine with artesunateDRUG
chlorproguanil-dapsoneDRUG

Eligibility Criteria

Age5 Weeks - 16 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Presenting for Pentavalent 1 immunization
  • Age 5 weeks to 16 weeks
  • Parent or guardian currently resident in study catchment area
  • Parent or guardian has given permission for their child to participate

You may not qualify if:

  • Known allergy to any of the study drugs
  • Current Cotrimoxazole prophylaxis
  • Concomitant disease requiring hospitalization or transfusion
  • Plans to be away from the study area for more than 6 months during the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lwak, Abidha, Ongielo and Saradidi clinics

Asembo (Rarieda Division), Nyanza Province, Kenya

Location

Related Publications (3)

  • Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, Tanner M, Mshinda H, Alonso P. Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet. 2001 May 12;357(9267):1471-7. doi: 10.1016/S0140-6736(00)04643-2.

    PMID: 11377597BACKGROUND

  • Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, Ronn AM, Theander TG, Bygbjerg IC. Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet. 2003 May 31;361(9372):1853-60. doi: 10.1016/s0140-6736(03)13504-0.

    PMID: 12788572BACKGROUND

  • Odhiambo FO, Hamel MJ, Williamson J, Lindblade K, ter Kuile FO, Peterson E, Otieno P, Kariuki S, Vulule J, Slutsker L, Newman RD. Intermittent preventive treatment in infants for the prevention of malaria in rural Western kenya: a randomized, double-blind placebo-controlled trial. PLoS One. 2010 Apr 2;5(4):e10016. doi: 10.1371/journal.pone.0010016.

    PMID: 20368815DERIVED

Related Links

MeSH Terms

Conditions

MalariaAnemiaMalaria, Falciparum

Interventions

fanasil, pyrimethamine drug combinationArtesunateAmodiaquinechloroguanil, dapsone drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Robert D Newman, MD, MPH

    U.S. Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

  • Laurence Slutsker, MD, MPH

    U.S. Centers for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2005

First Posted

May 18, 2005

Study Start

March 1, 2004

Primary Completion

March 1, 2006

Study Completion

March 1, 2008

Last Updated

September 27, 2012

Record last verified: 2012-09

Locations

KE(1)