By Stephen Asante
Accra, Sept. 26, GNA – Kumasi Centre for Collaborative Research in Tropical Medicine at the Kwame Nkrumah University of Science and Technology (KCCR-KNUST) is working with partner organisations to generate clinical and regulatory evidence required to support the use of ivermectin in children weighing five to 15 kilogrammes.
Ivermectin is an antiparasitic medicine widely used to control several neglected tropical diseases (NTDs), including onchocerciasis, lymphatic filariasis, scabies and some soil-transmitted helminth infections.
The project comes under the IVM-KIDS, a four-year Africa–Europe research partnership, with funding from the European Union’s Horizon Europe Research and Innovation Programme.
It is part of a broader global effort to ensure that mass drug administration (MDA) strategies are as inclusive and effective as possible.
The KCCR-KNUST, in a document copied to the Ghana News Agency (GNA), said children weighing less than 15 kg, broadly corresponding to children under five years of age, were not included in ivermectin-based public health programmes.
“This is because there is not yet sufficient safety evidence to support its use in this group,” the researchers noted.
Professor John Amuasi, the Scientific Project Leader of IVM-KIDS, explaining the objectives of the project’s maiden consortium in-person meeting, hosted by the KCCR-KNUST, in Accra, on Wednesday, said: “The question we are trying to answer is a very practical one.”
“Ivermectin is already an important tool for controlling neglected tropical diseases, but young children are still excluded because we do not yet have enough evidence on them to use it safely.”
“As researchers working in countries where these neglected tropical diseases remain a challenge, we have a responsibility to help generate evidence to inform the control and elimination of these diseases.”
The consortium meeting brought together researchers, clinicians, pharmaceutical experts and public health specialists from Ghana, Kenya, Tanzania, the Democratic Republic of Congo, the United Kingdom, Spain and Switzerland.
It allowed teams responsible for the different components of IVM-KIDS to coordinate the upcoming clinical research, regulatory work, stakeholder engagement and implementation activities to ensure studies conducted across different countries follow a common strategy.
The KCCR-KNUST indicated that the research had particular relevance in Ghana as the country has had decades of experience in the control of neglected tropical diseases, such as onchocerciasis and lymphatic filariasis.
“By extending the reach of these campaigns to children currently untreated, we can improve their lives and accelerate progress towards the elimination goals in the World Health Organisation’s 2021-2030 NTD Roadmap,” Dr Stella Kepha, Principal Research Scientist, Kenya Medical Research Institute (KEMRI), said in an interview.
Professor Michael Marks of the London School of Hygiene and Tropical Medicine (LSHTM), and Principal Investigator of IVM-KIDS, said: “Ivermectin has transformed the control of several parasitic diseases, but the youngest children are still left out because we do not yet have the evidence needed to routinely treat them.”
He expressed optimism that the IVM-KIDS project would help to address that gap by generating the safety, dosing, efficacy, and acceptability data that regulators and policymakers needed.
According to the project’s concept note, over four years, the IVM-KIDS research partnership would conduct a coordinated programme of clinical research to evaluate the safety, pharmacokinetics, and efficacy of ivermectin in children weighing between five and 15 kilogrammes.
“The project will assess both generic ivermectin and a new child-friendly 3mg orodispersible formulation, designed to dissolve in the mouth and make administration easier for this population,” it said.
The clinical research programme includes studies related to Trichuris trichiura, an intestinal parasite that causes anaemia, stunting and impaired development, as well as scabies.
It will also examine appropriate dosing and the acceptability of the new formulation to children and caregivers.
“The aim is not simply to establish whether ivermectin can be safely used in younger children, but to generate evidence strong enough to inform regulators, the World Health Organisation and national neglected tropical disease programmes and extend its indication to include children under 15 kg,” the document said.
GNA
Edited by Agnes Boye-Doe
Reporter: Stephen Asante