Kenya joins international push to develop new antibiotics for vulnerable newborns
By Hellen Shikanda, Health and Science Reporter, Nation Media Group
Kenyan scientists are developing new antibiotics for vulnerable babies aged between zero and 28 days to help treat neonatal sepsis, a life-threatening blood infection. Kenya is one of eight countries globally participating in the NeoSep1 study, which is now entering its second phase. This phase will focus on examining the safety and efficacy of the new antibiotics and how they are likely to reduce deaths related to neonatal sepsis. Dr Christina Obiero, Principal Investigator of the study and a clinician scientist at Kemri-Wellcome Trust, says that apart from developing new treatments for children, the goal is also to address antimicrobial resistance for that age group. “There are high rates of resistance to the currently used antibiotics, including penicillin and gentamicin. We have antimicrobial resistance being a big problem, which affects the outcomes of these babies. Then what are we going to do in case the antibiotics we are using fail to work?” she asks.
Dr Obiero explains that if a baby that young gets sepsis, they may either die or, if they survive, could have poor neurodevelopmental outcomes relating to the brain. “The ones who survive and go home may end up having complications as they grow older. This could range from impairment in their vision, hearing, or their cognitive function,” she explains. On Wednesday this week, the researchers received a green light to start screening and enrolling babies in the study after obtaining parental consent. The babies will then begin receiving the new antibiotics, and the research team will monitor them daily as they receive treatment whilst collecting data and checking for any adverse events. They will be followed up for 90 days. “As we investigate them in the trial, we are also going to be comparing the antibiotic regimens that are currently used in our hospitals, both in the public and private sectors,” she explains.
Dr Obiero explains that the trial will use a combination of drugs—some have been in existence for years but have not been used for children that age, and in Africa. The new combinations include fosfomycin and flomoxef given together or with amikacin. The combinations currently used are penicillin and ampicillin and related antibiotics, cephalosporins, piperacillin, tazobactam or amikacin, and meropenem. She says this study is important because the current guidelines have not been updated with new evidence for over a decade due to limited research on antibiotics in babies. Since antimicrobial resistance is key to this study, all babies enrolled will have a blood culture done, and then the culture results will guide the scientists on decisions around which antibiotics they need to continue with whilst on the ward.
Prof Samuel Kariuki, Continental Lead and Eastern Africa Director for the Drugs for Neglected Diseases initiative, explains that sepsis is a broad term that refers to infections that mainly affect the bloodstream of neonates, but can also affect other tissues and internal organs when it spreads from the bloodstream. “Usually, it’s a very severe disease. If not well managed within a very short time, a lot of these neonates will die within 24 to 48 hours,” he says. He explains that at that young age, the babies’ immune systems are still poorly formed, since they are still developing.
At that age, the natural protection against pathogens is not that great.”These pathogens, most of them, are usually drug resistant to many commonly available drugs. So, the options for treatment are very limited. That’s why new molecules must be developed that are more effective and that will ultimately manage sepsis for young children to be able to save their lives,” he explains. He says that since this is among the first of its kind studies in Africa, the scientists are looking into a rather neglected age group—one which is rarely considered in terms of formulating appropriate drug dosages for their age. “Once we have the outcomes, it will be very useful for other settings of a similar nature, both in the country but also in many other African countries where sepsis is also a big challenge for health,” he adds.
In the country, the study will be conducted at three sites: Coast General Referral Hospital in Mombasa, Mbagathi Hospital in Nairobi, and Kilifi County Referral Hospital in Kilifi. Other countries also conducting a similar study include South Africa, Ghana, India, Bangladesh, Pakistan, Malaysia, and Vietnam. About 3,000 children will be part of it.
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