Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
600
Anthelminthic drugs for the treatment of soil-transmitted helminths
Anthelminthic drugs for the treatment of schistosomiasis
SMC partner drug
SMC partner drug
Saraya Health Centre
Saraya, Région de Kédougou, Senegal
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events will be measured by collecting solicited and unsolicited adverse events and adverse drug reactions for causal relationships to the study drugs.
Time frame: For six consecutive days after start of the drug administration
Prevalence of helminth co-infection
Faecal egg counts for soil transmitted helminths
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Prevalence of Schistosoma co-infection
Urine egg counts for Schistosoma haematobium
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Prevalence of intensity of helminth infection
Arithmetic mean intensity of helminth infection
Time frame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
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