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

Malaria Clinical Trial

— MALHELMIN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05354258
• Other study ID #: 26770
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 16, 2022
• Est. completion date: September 2023

Study information

• Verified date: April 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: September 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malaria
• Schistosomiasis
• Soil Transmitted Helminths

Intervention

Drug:
• Albendazole
Anthelminthic drugs for the treatment of soil-transmitted helminths
• Praziquantel
Anthelminthic drugs for the treatment of schistosomiasis
• Amodiaquine
SMC partner drug
• Sulfadoxine pyrimethamine
SMC partner drug

Locations

Country	Name	City	State
Senegal	Saraya Health Centre	Saraya	Kedougou

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Université de Thies, UFR Santé, Senegal

Country where clinical trial is conducted

Senegal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of anaemia	Haemoglobin concentration of all study children will be checked using HemoCue®	On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Primary	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	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
Secondary	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
Secondary	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