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

London School of Hygiene and Tropical Medicine

Status: Unknown

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

Treatments: Drug: Sulfadoxine pyrimethamine; Drug: Praziquantel; Drug: Albendazole; Drug: Amodiaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT05354258

26770

Details and patient eligibility

About

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

Enrollment: 600 estimated patients

Sex: All

Ages: 1 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups, including a placebo group

Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3

Placebo Comparator group

Treatment:

Drug: Sulfadoxine pyrimethamine

Drug: Amodiaquine

Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3

Experimental group

Treatment:

Drug: Praziquantel

Drug: Sulfadoxine pyrimethamine

Drug: Amodiaquine

Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3

Experimental group

Treatment:

Drug: Praziquantel

Drug: Sulfadoxine pyrimethamine

Drug: Amodiaquine

Drug: Albendazole