Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children

Study Overview
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Brief Summary
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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

Official Title
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Feasibility and Effectiveness of Delivering Mass Drug Administration for Helminths Through the Seasonal Malaria Chemoprevention (SMC) Platform in a West African Paediatric Population

Conditions
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Malaria, Soil Transmitted Helminths, Schistosomiasis, Integrated Control, Seasonal Malaria Chemoprevention, Mass Drug Administration With Anthelminthic Drugs

Intervention / Treatment
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* Drug: Albendazole
* Drug: Praziquantel
* Drug: Amodiaquine
* Drug: Sulfadoxine pyrimethamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female children aged 1-14 years; Provision of a written informed consent by the parent/caregiver and a positive assent by children aged ≥ 12 years (in line with legal regulations in Senegal); Willingness to provide finger-prick blood samples, urine, and stool samples; Residence in the study area for at least six months Exclusion Criteria: Acutely ill child at the time of the drug administration; Child whose parents/caregivers decline to provide consent; A known HIV positive child receiving cotrimoxazole prophylaxis; A child who has received a dose of any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel during the previous six months; A child with a known allergy to any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3<br> | Drug: Amodiaquine<br>* SMC partner drug<br>Drug: Sulfadoxine pyrimethamine<br>* SMC partner drug<br>|
| Experimental: Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3<br> | Drug: Praziquantel<br>* Anthelminthic drugs for the treatment of schistosomiasis<br>Drug: Amodiaquine<br>* SMC partner drug<br>Drug: Sulfadoxine pyrimethamine<br>* SMC partner drug<br>|
| Experimental: Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3<br> | Drug: Albendazole<br>* Anthelminthic drugs for the treatment of soil-transmitted helminths<br>Drug: Praziquantel<br>* Anthelminthic drugs for the treatment of schistosomiasis<br>Drug: Amodiaquine<br>* SMC partner drug<br>Drug: Sulfadoxine pyrimethamine<br>* SMC partner drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | For six consecutive days after start of the drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of helminth co-infection | Faecal egg counts for soil transmitted helminths | 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 | 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 | On the day of randomisation (pre-intervention) and up to 4 months post-intervention |