Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universiteit Antwerpen
• Collaborators: Fund for Scientific Research, Flanders, Belgium; University of Kinshasa
• Treatments: Albendazole; Fanasil, pyrimethamine drug combination; Piperaquine; Praziquantel; Pyrimethamine; Sulfadoxine; Triclabendazole

Criteria

Inclusion Criteria:

• males and females in primary school children,

• anticipated local residence for the study duration,

• signed or thumb-printed informed consent by the parents or guardians and witnessed by an impartial witness (whenever parents/guardians are illiterate)

Exclusion Criteria:

• Children of the 6th primary school year

• Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.

• Known hypersensitivity or serious adverse drug reaction (ADR) to the study drugs.

• Clinical malaria at baseline irrespectively of the severity (World Health Organisation malaria treatment guideline 2010) (Annex III).

• Febrile conditions caused by diseases other than malaria at first visit.

• Clinical symptoms of severe anaemia

• Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known Glucose 6 phospahate dehydrogenase (G6PD) deficiency and sickle cell (SS form).

• Body weight < 14 kg Children with major chronic infectious diseases (HIV, Tuberculosis, ...)