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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-16

Study Completion Date

2023-09-30

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type PLACEBO_COMPARATOR

Amodiaquine

Intervention Type DRUG

SMC partner drug

Sulfadoxine pyrimethamine

Intervention Type DRUG

SMC partner drug

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

Group Type EXPERIMENTAL

Praziquantel

Intervention Type DRUG

Anthelminthic drugs for the treatment of schistosomiasis

Amodiaquine

Intervention Type DRUG

SMC partner drug

Sulfadoxine pyrimethamine

Intervention Type DRUG

SMC partner drug

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

Group Type EXPERIMENTAL

Albendazole

Intervention Type DRUG

Anthelminthic drugs for the treatment of soil-transmitted helminths

Praziquantel

Intervention Type DRUG

Anthelminthic drugs for the treatment of schistosomiasis

Amodiaquine

Intervention Type DRUG

SMC partner drug

Sulfadoxine pyrimethamine

Intervention Type DRUG

SMC partner drug

Interventions

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Albendazole

Anthelminthic drugs for the treatment of soil-transmitted helminths

Intervention Type DRUG

Praziquantel

Anthelminthic drugs for the treatment of schistosomiasis

Intervention Type DRUG

Amodiaquine

SMC partner drug

Intervention Type DRUG

Sulfadoxine pyrimethamine

SMC partner drug

Intervention Type DRUG

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes