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

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

Conditions

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

Interventions

DRUG

Albendazole

Anthelminthic drugs for the treatment of soil-transmitted helminths

DRUG

Praziquantel

Anthelminthic drugs for the treatment of schistosomiasis

DRUG

Amodiaquine

SMC partner drug

DRUG

Sulfadoxine pyrimethamine

SMC partner drug

Sponsors & Collaborators

• Université de Thies, UFR Santé, Senegal

  collaborator UNKNOWN

• London School of Hygiene and Tropical Medicine

  lead OTHER

Principal Investigators

• Brian Greenwood, MD, FMedSci · London School of Hygiene and Tropical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-06-16

Primary Completion

2022-11-30

Completion

2023-09-30

Countries

• Senegal

Study Locations