Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Considering the facts that: (i) IPT of malaria provides substantial protection against
      anaemia and malaria in school children (ii); SP resistance has no significant impact on the
      prophylactic efficacy (iii) SP-PQ is safe and as efficacious as SP: the investigators
      hypothesize that antimalarial IPT with SP and SP-PQ will improve haemoglobin concentration,
      reduce anaemia prevalence, malaria incidence and parasitaemia, and improve malnutrition and
      school performance in school-aged children of Congo.
    

Detailed description: 
      STUDY RATIONAL The education sector represents a reliable system for malaria control.
      Intermittent preventive therapy in schoolchildren (IPTsc) is likely the most feasible and
      appropriate chemoprevention in stable and endemic areas because schoolchildren are usually
      asymptomatic to malaria infection and are consequently untreated in practice. Therefore, if
      proven effective, IPTsc would be of direct benefit for the schoolchild, contribute to malaria
      control at school, and facilitate community-wide the implementation of other control
      interventions i.e. vector control, Intermittent preventive therapy in infants (IPTi), and
      prompt diagnosis and treatment (PDT). Nevertheless, evidence about use of IPTsc is not yet
      substantiated as only two clinical studies have so far been performed on IPTsc in hyper
      endemic areas. Further clinical trials are warranted in other settings. Through a randomised
      controlled trial (RCT) we will assess the efficacy and safety, of two IPT regimens versus
      controls in school children of the DRCongo.

      STUDY DRUGS Favourable drugs for use as IPT should balance long half-life against efficacy,
      safety, tolerability and potentiality for cross-resistance selection.(16) Use of long-acting
      drugs would result in fewer intake and higher treatment compliance. Sulfadoxine-pyrimethamine
      is an established used product in the indication of IPT in pregnancy. The drug has further
      proven safety and tolerability in children in clinical trials. SP is slowly eliminated and
      allows 60 days antimalaria protection for fully sensitive P. falciparum. Other long-acting
      drugs available are mefloquine, amodiaquine, and piperaquine. However, due safety concern
      mefloquine might not be optimal for IPT. Amodiaquine is not suitable for IPT due to its 3
      days treatment regimen that may be a concern regarding compliance. Piperaquine has been
      extensively used for mass prophylaxis and treatment since 1978 in China and other malaria
      endemic countries of Asia.(20) Piperaquine has a long half-live and points as good IPT
      candidate in endemic country with SP resistance. For this study sulfadoxine-pyrimethamine
      combined with piperaquine (SP-PQ) plus will be used. SP and SP-PQ will be given at 4 months
      intervals in line with the long half-lives (around 20 days) in paediatric patients and for
      higher treatment compliance,
    

Intervention name(s): Sulfadoxine-pyrimethamine; Piperaquine; Albendazole; Praziquantel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more; Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more.; One oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.; Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
Other intervention name(s): Fansidar
Intervention MeSH terms: Pyrimethamine; Piperaquine; Sulfadoxine; Fanasil, pyrimethamine drug combination; Albendazole; Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: intermittent; preventive; treatment; malaria; soil transmitted helminths; schistosomiasis; schoolchildren