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Rachel V Thomas

Sepsis: India Joins Global Trial To Screen Newborns For Deadly Drug-Resistant Infections

India has joined the Global Antibiotic Research and Development Partnership (GARDP)-led NeoSep1 clinical trial, a landmark international study evaluating new antibiotic treatments for newborns with drug-resistant <a href="https://www.healthandme.com/health/sepsis">sepsis</a>.

Sepsis is the second leading cause of neonatal mortality in India after prematurity and low birth weight, accounting for an estimated 30–40 per cent of all newborn deaths.

The NeoSep1 trial began in India with the first baby enrolled at the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Puducherry, followed by Pt. B.D. Sharma PGIMS in Rohtak. Lokmanya Tilak Municipal Medical College and General Hospital in Mumbai is also expected to begin enrolling newborns soon.

"Every day doctors face the heartbreaking reality of losing babies to sepsis due to lack of safe and effective treatments," said Dr Nishad Plakkal, Principal Investigator of the NeoSep1 trial in India and Associate Dean (Research) and Professor and Head of the Department of Neonatology at JIPMER.

"Having the right antibiotics at the right dose can tip the balance between life and death. This trial offers hope to change that," Plakkal added.

"The trial will give neonatologists new tools, and give babies with sepsis a fighting chance at life," said Sally Ellis, who leads GARDP's Children's Antibiotics Program.

<h2>Why Newborns Are At Greater Risk</h2>

Also read:<a href="https://www.healthandme.com/health-news/us-woman-nearly-died-after-brushing-off-sepsis-symptoms-as-flu-article-154513138" data-type="tilCustomLink">US Woman Nearly Died After Brushing Off Sepsis Symptoms As Flu</a>

According to Ellis, newborns are particularly vulnerable to life-threatening sepsis because of their underdeveloped immune systems.

The growing burden of antibiotic resistance in low- and middle-income countries (LMICs) has further worsened the problem by reducing the effectiveness of standard treatments. Studies have reported extremely high resistance to the combination of ampicillin and gentamicin, the antibiotic regimen currently recommended by the World Health Organization for the initial treatment of neonatal <a href="https://www.healthandme.com/health/sepsis">sepsis</a>.

"Today, we stand at a tipping point. The antibiotics for newborns that we have relied on for decades are failing against resistant infections in many hospital settings," Ellis said.

Read More: <a href="https://www.healthandme.com/health-news/andhra-pradesh-to-launch-rare-disease-policy-expand-universal-newborn-screening-article-154766853" data-type="tilCustomLink">Andhra Pradesh To Launch Rare Disease Policy, Expand Universal Newborn Screening</a>

An estimated 3 million newborns develop sepsis every year. The condition occurs when the body's response to an infection triggers widespread inflammation, potentially leading to tissue damage, organ failure, and death. More than 90% of neonatal sepsis deaths occur in low- and middle-income countries.

The NeoSep1 trial aims to identify safe and effective antibiotic regimens that can reduce deaths caused by drug-resistant neonatal sepsis.

The first phase of the study, conducted in South Africa and Kenya in 2023, validated the appropriate doses of fosfomycin and flomoxef when used in combination with other antibiotics in newborns.

The second phase is using a Personalised Randomised Controlled Trial (PRACTical) design to evaluate and rank multiple antibiotic regimens for newborns with sepsis. The approach is expected to help clinicians choose the most effective treatments based on local patterns of antibiotic resistance while also informing future national and international treatment guidelines.

The NeoSep1 trial is expected to enroll 3,000 newborns across Asia and Africa by the end of 2028.

Along with India, newborns have already been enrolled in Ghana, Kenya, and South Africa. Hospitals in Vietnam, Pakistan, Malaysia, Bangladesh, and Uganda are also expected to join the study.

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Sepsis is a life-threatening reaction to an infection that harms the immune system, tissues, and organs. It can lead to organ failure or death if not treated urgently, according to the Cleveland Clinic.

According to Sepsis Alliance, the acronym TIME can help people recognize potential warning signs of sepsis and seek urgent medical care.

T — Temperature: Body temperature is unusually high or low.

I — Infection: Signs or symptoms of an infection are present.

M — Mental Decline: Confusion, excessive sleepiness, or difficulty waking up.

E — Extremely Ill: Severe pain, extreme discomfort, or shortness of breath.

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India has joined the Global Antibiotic Research and Development Partnership (GARDP)-led NeoSep1 clinical trial, a landmark international study evaluating new antibiotic treatments for newborns with drug-resistant sepsis.Sepsis is the second leading cause of neonatal mortality in India after prematurity and low birth weight, accounting for an estimated 30–40 per cent of all newborn deaths.The NeoSep1 trial began in India with the first baby enrolled at the Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) in Puducherry, followed by Pt. B.D. Sharma PGIMS in Rohtak. Lokmanya Tilak Municipal Medical College and General Hospital in Mumbai is also expected to begin enrolling newborns soon."Every day doctors face the heartbreaking reality of losing babies to sepsis due to lack of safe and effective treatments," said Dr Nishad Plakkal, Principal Investigator of the NeoSep1 trial in India and Associate Dean (Research) and Professor and Head of the Department of Neonatology at JIPMER."Having the right antibiotics at the right dose can tip the balance between life and death. This trial offers hope to change that," Plakkal added."The trial will give neonatologists new tools, and give babies with sepsis a fighting chance at life," said Sally Ellis, who leads GARDP's Children's Antibiotics Program.Why Newborns Are At Greater RiskAlso read:US Woman Nearly Died After Brushing Off Sepsis Symptoms As FluAccording to Ellis, newborns are particularly vulnerable to life-threatening sepsis because of their underdeveloped immune systems.The growing burden of antibiotic resistance in low- and middle-income countries (LMICs) has further worsened the problem by reducing the effectiveness of standard treatments. Studies have reported extremely high resistance to the combination of ampicillin and gentamicin, the antibiotic regimen currently recommended by the World Health Organization for the initial treatment of neonatal sepsis."Today, we stand at a tipping point. The antibiotics for newborns that we have relied on for decades are failing against resistant infections in many hospital settings," Ellis said.What Is The NeoSep1 Trial?Read More: Andhra Pradesh To Launch Rare Disease Policy, Expand Universal Newborn ScreeningAn estimated 3 million newborns develop sepsis every year. The condition occurs when the body's response to an infection triggers widespread inflammation, potentially leading to tissue damage, organ failure, and death. More than 90% of neonatal sepsis deaths occur in low- and middle-income countries.The NeoSep1 trial aims to identify safe and effective antibiotic regimens that can reduce deaths caused by drug-resistant neonatal sepsis.The first phase of the study, conducted in South Africa and Kenya in 2023, validated the appropriate doses of fosfomycin and flomoxef when used in combination with other antibiotics in newborns.The second phase is using a Personalised Randomised Controlled Trial (PRACTical) design to evaluate and rank multiple antibiotic regimens for newborns with sepsis. The approach is expected to help clinicians choose the most effective treatments based on local patterns of antibiotic resistance while also informing future national and international treatment guidelines.The NeoSep1 trial is expected to enroll 3,000 newborns across Asia and Africa by the end of 2028.Along with India, newborns have already been enrolled in Ghana, Kenya, and South Africa. Hospitals in Vietnam, Pakistan, Malaysia, Bangladesh, and Uganda are also expected to join the study.   Warning Signs of SepsisSepsis is a life-threatening reaction to an infection that harms the immune system, tissues, and organs. It can lead to organ failure or death if not treated urgently, according to the Cleveland Clinic.According to Sepsis Alliance, the acronym TIME can help people recognize potential warning signs of sepsis and seek urgent medical care.T — Temperature: Body temperature is unusually high or low.I — Infection: Signs or symptoms of an infection are present.M — Mental Decline: Confusion, excessive sleepiness, or difficulty waking up.E — Extremely Ill: Severe pain, extreme discomfort, or shortness of breath.

sepsis: india joins global trial to screen newborns for deadly drug-resistant infections

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