Intermittent Preventive Treatment With Antimalarials in Kenyan Infants
Condition: Malaria; Anemia
MeSH terms: Malaria; Anemia
Study type: Interventional

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.
    

Detailed description: 
      Approximately three quarters of preschool children in eastern Africa suffer from anemia,
      defined as a hemoglobin (Hb) concentration below 11 g/dL. For children < 5 years of age, the
      overall incidence of severe malarial anemia (Hb < 5 g/dl) is estimated at 15-60 cases per
      1,000 children per year. Other studies have confirmed that the burden of malaria-related
      anemia falls primarily on infants and young children. In 2000, Schellenberg and colleagues,
      working in an area of Tanzania with a low to moderate level of Plasmodium falciparum
      transmission and a low level of sulfadoxine-pyrimethamine (SP) resistance, demonstrated that
      by linking intermittent prophylaxis to routine immunization visits through the national
      Expanded Program on Immunization (EPI), SP could be administered to children at 2,3, and 9
      months of age, resulting in a 59% reduction in rates of clinical malaria and a 50% reduction
      in the rate of severe anemia (Hb<8 g/dl) compared to those receiving placebo. This
      randomized, double blind, placebo-controlled trial is being conducted to estimate the
      efficacy of Intermittent Preventive Treatment for Infants (IPTi) with SP + three doses of
      artesunate (AS) (SP/AS3) given in combination with iron supplementation from 2-6 months of
      age at routine EPI visits on the prevention of clinical malaria, moderate anemia, and severe
      anemia in the first 18 months of life in an area with intense malaria transmission and near
      universal ownership of insecticide treated nets (ITNs). The primary objective is to compare
      the efficacy of iron supplementation and IPTi with one of 3 antimalarial regimens (SP/AS3,
      chlorproguanil-dapsone (Lapdap), or AQ/AS3) given at routine EPI visits with iron
      supplementation alone (+ placebo) on the prevention of clinical malaria in the first year of
      life. Specific secondary objectives are: 1) Compare the efficacy of iron supplementation plus
      IPTi with one of 3 antimalarial regimens (SP/AS3, Lapdap [chlorproguanil-dapsone], or AQ/AS3)
      given at routine EPI visits with iron supplementation alone (+ placebo) on the prevention of
      moderate and severe anemia in the first year of life; 2) Assess the impact of IPTi with the
      aforementioned regimens on serologic responses to EPI vaccines (Polio, Diphtheria, Tetanus,
      Pertussis, Hepatitis B, Hemophilus Influenzae type B, and Measles; 3) Assess the impact of
      IPTi with the aforementioned regimens (particularly SP/AS3) on the nasal carriage rates of
      Haemophilus influenza type b; and 4) Compare the efficacy of iron supplementation and IPTi
      with one of 3 antimalarial regimens (SP/AS3, Lapdap [chlorproguanil-dapsone], or AQ/AS3)
      given at routine EPI visits with iron supplementation alone (+ placebo) on the prevention of
      all-cause hospitalization in the first year of life. This trial will generate important
      public health information on the efficacy of IPTi in preventing anemia and clinical malaria
      among infants in an area with intense malaria transmission and ongoing prevention efforts
      through the use of insecticide treated nets. This trial will contribute towards understanding
      IPTi's mechanism of action (i.e. through intermittent clearance of parasites vs. a
      chemoprophylactic effect afforded through the use of an antimalarial with a long half-life).
      The information gained will be useful to determine the safety of IPTi, and to decide what
      sort of antimalarials are appropriate for IPTi, and ultimately will help to direct child
      survival and malaria control policy in African countries. If alternative drug regimes to SP
      prove effective, that information will be valuable to policymakers as levels of P. falciparum
      resistance to SP rise with increased usage in east Africa.
    

Intervention name(s): sulfadoxine-pyrimethamine with artesunate; amodiaquine with artesunate; chlorproguanil-dapsone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Artesunate; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine; Dapsone; Chlorproguanil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
Keywords: malaria; anemia; Plasmodium falciparum; infants; prevention; safety; efficacy; antimalarials