Intermittent Preventive Treatment (IPTi) for the Prevention of Malaria and Anaemia in PNG Infants
Condition: Malaria; Anemia
MeSH terms: Malaria; Anemia
Study type: Interventional

Summary: 
      In malaria-endemic areas, young children have an especially high risk of malaria morbidity
      and mortality. Malaria is estimated to cause up to 2 million deaths and 500 million clinical
      episodes in Africa alone. The bulk of disease in Africa and severe disease and deaths
      globally is due to P. falciparum. However, P. vivax is also responsible for a substantial
      disease burden in endemic regions outside Africa, where P. vivax may account for more than
      half of all malaria cases. Efforts to reduce this unacceptably high disease burden are
      hampered by the limited availability of affordable interventions. Following the cessation of
      large-scale vector control in highly endemic areas, malaria control efforts have centred on
      early diagnosis and treatment of clinical cases and reducing exposure through the use of
      insecticide-treated nets (ITNs). While ITNs have been shown to significantly reduce the
      burden of malaria additional effective interventions are urgently needed.

      Several trials have shown that chemoprophylaxis given to children at weekly or fortnightly
      intervals reduces morbidity from malaria in a number of different settings and populations.

      An alternative approach has been to use intermittent preventive therapy (IPT) involving the
      administration of a full therapeutic dose of antimalarials at regular intervals. This is
      logistically easier to deliver, and is less costly, and may reduce problems of promoting drug
      resistance associated with regular chemoprophylaxis. Intermittent administration of
      sulphadoxine-pyrimethamine (SP) during antenatal clinic visits was shown to be highly
      effective in reducing malaria and anaemia in pregnant women and improving infant birth
      weights. IPT in pregnancy (IPTp) is now recommended by WHO for endemic regions of Africa.
    

Detailed description: 
      Intermittent preventive treatment in infancy (IPTi) is one of the most promising recent
      interventions to reduce the devastating impact of malaria in early childhood. Although two
      African studies have provided the proof of principle, further studies are needed to address
      several key issues. IPTi needs additional evaluation in a variety of settings and
      populations, alternative drugs and treatment schedules need to be tested and the long-term
      effect of IPTi on risk of malaria illness through early childhood needs to be clarified.

      Many of these issues are currently being addressed in a series of studies conducted under the
      auspice of the IPTi Consortium. However, all these studies are based in sub-Saharan Africa
      and are thus almost exclusively concerned with the potential of IPTi to prevent P. falciparum
      malaria.

      In order to determine whether IPTi is also an effective intervention in areas where there is
      a high prevalence of non-falciparum infections, further studies outside Africa are urgently
      needed. In addition, although initial IPTi studies have not shown a rebound in malaria
      morbidity following the intervention, the influence of IPTi on the acquisition of functional
      malaria immunity needs further investigation.

      This proposal brings together investigators, experience, and resources to conduct a clinical
      trial of IPTi complemented by careful epidemiologic and laboratory investigations in two
      highly endemic areas of Papua New Guinea, where infections with all 4 human Plasmodium
      species are common. The studies will be based at the PNG Institute for Medical Research,
      which has excellent infrastructure and a strong history of malaria research and
      community-based studies
    

Intervention name(s): Amodiaquine/sulphadoxine-pyrimethamine, Artesunate/sulphadoxine-pyrimethamine or placebo
Intervention type(s): Drug
Intervention description(s): Children will get 25mg/1.25mg/kg of SP as a single dose, 4 mg/kg for 3 days of Artesunate and 10 mg/kg for 3 days of Amodiaquine in their respective arms
Intervention MeSH terms: Artesunate; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: IPTi; Malaria; Anemia; Prevention; Infant; Artesunate; SP; Amodiaquine; Papua New Guinea