NeoSep1
A global study comparing and ranking novel and currently used antibiotic regimens for the empiric treatment of newborns hospitalised with severe sepsis.
Sponsored by GARDP, NeoSep1 will involve around 1,200 newborns in African countries. With additional support, GARDP will expand the trial to countries in Asia Pacific.
The entire study will include 3,000 newborns aged 28 days or less who are in hospital with a clinical diagnosis of sepsis and to be treated with antibiotics.
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Why is NeoSep1 needed?
- Many newborns, especially in resource-limited settings, face a high risk of death due to severe infections and sepsis.
- Infections are increasingly caused by bacteria that no longer respond to commonly used antibiotics, including those recommended by the World Health Organization. This is making treatment more and more difficult.
- There is a growing need for new, effective antibiotic combinations to combat sepsis in newborns, especially as resistance to current treatments is on the rise.
Trial objectives
NeoSep1 aims to:
- Evaluate how well different antibiotic combinations work compared to current global standards, and rank them according to effectiveness and safety.
- Identify the best second-line antibiotics for babies who do not improve or deteriorate after first-line treatment.
Trial activities:
Before the trial begins, each site will select up to eight of the following first-line treatment regimens from the provided list.
The selection of the most clinically appropriate first-line treatment regimens for each site will be determined collaboratively between the site and the trial team, considering site-specific and baby-specific factors (e.g., whether a baby has early or late onset sepsis).
- Ampicillin + Gentamicin
- Cefotaxime or ceftriaxone
- Fosfomycin + Amikacin
- Flomoxef + Amikacin
- Fosfomycin + Flomoxef
- Ceftazidime
- Ceftazidime + Amikacin
- Piperacillin/Tazobactam
- Piperacillin/Tazobactam + Amikacin
- Meropenem
Once the trial starts:
- Babies will receive first-line antibiotics for approximately 7-10 days.
- If a baby’s condition worsens or doesn’t improve as expected, second-line antibiotics will be given to see if they do better with different treatments.
- Second-line antibiotics may be chosen randomly from a set of options, if clinically appropriate, and will be different from the first-line treatment.
- Babies will be monitored for 90 days, with follow-up visits or calls at 28 and 90 days to check on their progress.
Who participates?
In Africa, NeoSep1 will be carried out in 8 sites:
- Kumasi Centre for Collaborative Research in Tropical Medicine, Kumasi, Ghana
- Kilifi County Hospital, Kilifi, Kenya
- Mbagathi Hospital, Nairobi, Kenya
- Coast General Teaching and Referral Hospital, Mombasa, Kenya
- Chris Hani Baragwanath Hospital, Johannesburg, South Africa
- Tygerberg Hospital, Cape Town, South Africa
- Kawempe National Referral Hospital, Kampala, Uganda
- Mulago Specialised Women and Neonatal Hospital, Kampala, Uganda
