Clinical trial NCT05354258: Feasibility and Safety of Combining Anti-malarial With Deworming Drugs in African Children
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malaria
Soil Transmitted Helminths
Schistosomiasis
Integrated Control
Seasonal Malaria Chemoprevention
Mass Drug Administration With Anthelminthic Drugs
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Université de Thies, UFR Santé, Senegal
First posted: 2022-04-29
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: For six consecutive days after start of the drug administration
Secondary outcomes:
measure: Prevalence of helminth co-infection
timeFrame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
measure: Prevalence of Schistosoma co-infection
timeFrame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
measure: Prevalence of intensity of helminth infection
timeFrame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Other outcomes:
measure: Prevalence of anaemia
timeFrame: On the day of randomisation (pre-intervention) and up to 4 months post-intervention
Locations:
city: Saraya
country: Senegal
facility: Saraya Health Centre
state: Kedougou
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Brian Greenwood, MD, FMedSci
role: STUDY_DIRECTOR
References:
citation: Afolabi MO, Sow D, Ndiaye JLA, Greenwood B. Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial. Trials. 2022 Aug 3;23(1):627. doi: 10.1186/s13063-022-06579-0.