A 5-year clinical investigation to improve survival outcomes among high-risk children.

Diarrhoea remains one of the leading causes of death in children under five, and most of those deaths happen in sub-Saharan Africa. Between a quarter and half of watery diarrhoea episodes are caused by bacteria. Even so, WHO guidelines currently recommend against antibiotics for acute watery diarrhoea, and make no recommendation at all for children at high risk of dying from it.

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That gap matters most for children who are also malnourished. Earlier trial data found that children with stunting or wasting who received azithromycin had a 38% reduction in death or hospitalisation. Malnourished children are also more likely to have a bacterialcause for their diarrhoea, and climate change is expected to push that likelihood higher still.

TARGET is a randomised trial comparing three days of azithromycin, three days of ciprofloxacin, and placebo in 2,800 children aged 2 to 59 months who present with acute watery diarrhoea and either stunting or wasting.

Recruitment happens at sites in Kenya (1,800 children) and Tanzania (1,000 children), with each child followed for 90 days. Alongside the trial, we test a point-of-care haemoglobin tool that could helpclinics identify, quickly and cheaply, which children are most likely to benefit from antibiotics.

About

TARGET runs for 54 months, from July 2026 to December 2030, funded by the European Union through the Global Health EDCTP3 Joint Undertaking.

The partners

Governance

Trial locations

Blonde woman smiling and looking at a young girl who is writing on a clipboard with a red pen.

THE PARTNERS

9 organisations

Nine partner organisations across Europe, Africa and North America bring together clinical trial delivery, laboratory science, climate science, social science and policy translation, to make sure the evidence is delivered to the committees responsible for setting clinical guidelines.

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Governance

Advisory board

An independent Project Advisory Board of external experts in paediatrics, clinical trial methodology ,antimicrobial resistance, ethics and climate science reviews TARGET's design and results as the trial progresses.

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trial Location

2 countries, 4 sites

Four sites enrol children into TARGET: three hospitals in Nyanza province, Kenya (Homa Bay County Referral Hospital, Rongo District Hospital and Siaya County Referral Hospital, plus their satellite clinics) and Haydom Lutheran Hospital in Tanzania, plus three nearby dispensaries.