Malaria Clinical Trial
Official title:
The Effect of Schistosome and Soil-transmitted Helminth Infections on Malaria,Infection, Morbidity and Antibody Response Among School and Pre-school Children in Mwanza, Tanzania
The proposed study has as the main objective to investigate the effect of schistosome and STH infections and the effect of an anthelminthic intervention on P. falciparum malaria, related anaemia and malaria antibody responses among school and pre-school children in Mwanza, Tanzania. The study will include a cross-sectional baseline survey followed by an anthelminthic intervention trial of two years duration. At baseline, prevalence and intensity of malaria, schistosome and STH infections and the prevalence of anaemia will be determined by examination of blood, faecal and urine samples. Spleen and liver size and consistency will be determined by palpation. P. falciparum specific antibodies will be determined by ELISA. All children will be treated with a single dose of praziquantel 40mg/kg and albendazole 400mg. Children selected to participate in the intervention trial will be randomized into two groups, an intervention group of 258 children which will be followed up with albendazole 400mg and praziquantel 40mg/kg at three months interval and a control group of 258 children which will be followed up with praziquantel 40mg/kg and albendazole 400mg once a year in accordance with the National Schistosomiasis and Soil-transmitted Helminths Control Programme. At 12 months and 24 months follow-up, all examinations conducted at baseline survey will be repeated.
alaria is a major public health problem in tropical and subtropical countries particularly
sub-Saharan Africa. Studies have shown that in Tanzania malaria, schistosome and
soil-transmitted helminth infections (STH) (Hookworms, Ascaris lumbricoides and Trichuris
trichiura) are co-endemic and that they share the human hosts. It has been hypothesized that
co-infection with schistosomes and STH may modulate the immune response to Plasmodium
falciparum leading to increased susceptibility to clinical malaria and severity of cases.
The proposed study has as the main objective to investigate the effect of schistosome and
STH infections and the effect of an anthelminthic intervention on P. falciparum malaria,
related anaemia and malaria antibody responses among school and pre-school children in
Mwanza, Tanzania. The study will include a cross-sectional baseline survey followed by an
anthelminthic intervention trial of two years duration. At baseline, prevalence and
intensity of malaria, schistosome and STH infections and the prevalence of anaemia will be
determined by examination of blood, faecal and urine samples. Spleen and liver size and
consistency will be determined by palpation. P. falciparum specific antibodies will be
determined by ELISA. All children will be treated with a single dose of praziquantel 40mg/kg
and albendazole 400mg. Children selected to participate in the intervention trial will be
randomized into two groups, an intervention group of 258 children which will be followed up
with albendazole 400mg and praziquantel 40mg/kg at three months interval and a control group
of 258 children which will be followed up with praziquantel 40mg/kg and albendazole 400mg
once a year in accordance with the National Schistosomiasis and Soil-transmitted Helminths
Control Programme. At 12 months and 24 months follow-up, all examinations conducted at
baseline survey will be repeated. If an effect of schistosome and STH infections on malaria
infection and morbidity is demonstrated, control of these diseases could provide another
feasible and affordable way of reducing malaria morbidity. Results of the proposed study
will contribute to the understanding of the epidemiology and control of malaria in the
context of other co-endemic diseases and may be important in the planning of integrated
disease control strategies.
Keywords: P. falciparum, malaria, schistosome infections, soil-transmitted helminths
infection, anaemia, immune response, Tanzania
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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