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.
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,
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.
Mokali health area of Biyela health zone, in Kinshasa province.
Kinshasa, Kinshasa Province, Republic of the Congo
Hemoglobin change
Change in mean Hb concentration at month 12 of follow-up and anaemia prevalence one year after initial preventive treatment;
Time frame: Month 0-Month 12
Change in mean Hb concentration at month 4 and 8 of follow-up
Time frame: Month 0 - Month 4 - Month 8
Prevalence of asymptomatic and clinical malaria at baseline & one year after enrolment;
Time frame: Month 0 Month 12
Prevalence of P. falciparum dihydrofolate reductase (dhfr) and dihydropteroate synthase (dhps) gene mutations at baseline and at month 12 follow-up
Time frame: Month 0 - Month 12
Clinical (severe) malaria incidence and parasitaemia at month 4, 8, 12;
Time frame: Month 4, 8 12
Percentages of acute and severe malnourished at month 0, 4, 8, 12 through z-scores, W/H, H/A, and skinfolds
Time frame: Month 0 - Month 12
Educational achievement, at end of follow-up, and school attendance;
Time frame: Month 0 - Month 12
Prevalence and risk of environmental and host-related predictors for malaria (re)infections;
Time frame: Month 0- Month 12
adverse events
Time frame: Month 0- Months 12
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
616
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.