www.cidrap.umn.edu/antimicrobial-st...natal-sepsis-largely-ineffective-low-resource
Recommended antibiotics for neonatal sepsis largely ineffective in low-resource nations, study finds
Chris Dall, MA
32 minutes ago.
Antimicrobial Stewardship
Sepsis
New data presented at the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases (ESCMID) in Munich highlight the challenge of treating a deadly infection in newborns in low- and middle-income countries (LMICs).
The data are from the BARNARDS (Burden of Antibiotic Resistance in Neonates from Developing Societies) II study, a prospective study investigating antibiotic use and clinical outcomes in newborns with sepsis in Pakistan, Nigeria, and Bangladesh. An estimated 200,000 newborns die each year from sepsis, which occurs when bacteria or fungi enter the bloodstream and trigger a systemic, overwhelming inflammatory reaction. More than 90% of those deaths are in LMICs.
The World Health Organization (WHO) recommends the combination of ampicillin plus gentamicin for empiric treatment of neonatal sepsis. But the first BARNARDS study, conducted from 2015 through 2018, found extremely high rates of resistance to the combination therapy, raising questions over whether the WHO should revise its recommendations.
The findings from BARNARDS II, a prospective study led by researchers from the University of Oxford’s Ineos Oxford Institute (IOI), are no different. Of the 14,259 newborns treated empirically for suspected sepsis from February 2024 to October 2025 at 13 neonatal units in the three countries, only 40 received the ampicillin-gentamicin combination. Analysis of 2,821 culture-confirmed cases with pathogen identification and antibiotic-susceptibility data found that ampicillin-gentamicin would have been active against only 25% of those cases.
“In these settings, ampicillin and gentamicin would have provided limited coverage against the locally prevalent, highly resistant pathogens,” lead author Kathryn Thomson, PhD, of IOI, said in an ESCMID press release yesterday.
Thomson and her colleagues said the limited ineffectiveness of ampicillin and gentamicin explains why clinicians opted for other two-drug combinations, most frequently amikacin plus cefotaxime.
“Rather than reflecting poor adherence to guidelines, this likely represents adaptation to local resistance patterns and the challenges of applying global treatment recommendations in these environments,” she said.
No ‘one-size-fits-all’ approach
Still, only 37% of the culture-confirmed sepsis case-patients received appropriate empiric therapy, which was associated with a 17.9% mortality rate. Mortality for inappropriate empiric therapy was nearly twofold higher (32.1%) in the unadjusted analyses, but adjusted analysis found that underlying clinical factors, primarily gestational age, were largely responsible for the higher mortality rate.
The authors note that one of the problems with the WHO recommendation for empiric treatment of neonatal sepsis is that it’s based on data from high-income countries, and the distribution of pathogens and patterns of antimicrobial resistance (AMR) are much different in LMICs. Treatment needs to be administered within hours to prevent tissue damage, organ failure, and death in newborns, who are highly vulnerable to drug-resistant infections, but clinicians in LMICs have limited local data to guide appropriate antibiotic therapy.
In these settings, ampicillin and gentamicin would have provided limited coverage against the locally prevalent, highly resistant pathogens.
Co-author Timothy Walsh, DSc, also of IOI, said the findings show that the “one-size-fits-all” approach for neonatal sepsis treatment guidelines is “unlikely to be effective globally.”
“Even across the countries included in this study, we observed important differences in both the pathogens responsible for infection and their resistance profiles,” Walsh said.
Walsh added that improving neonatal sepsis outcomes in LMICs will require locally informed empiric treatment strategies, enhanced diagnostics, continued AMR surveillance, and sustainable access to effective antibiotics.
Recommended antibiotics for neonatal sepsis largely ineffective in low-resource nations, study finds
Chris Dall, MA
32 minutes ago.
Antimicrobial Stewardship
Sepsis
New data presented at the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases (ESCMID) in Munich highlight the challenge of treating a deadly infection in newborns in low- and middle-income countries (LMICs).
The data are from the BARNARDS (Burden of Antibiotic Resistance in Neonates from Developing Societies) II study, a prospective study investigating antibiotic use and clinical outcomes in newborns with sepsis in Pakistan, Nigeria, and Bangladesh. An estimated 200,000 newborns die each year from sepsis, which occurs when bacteria or fungi enter the bloodstream and trigger a systemic, overwhelming inflammatory reaction. More than 90% of those deaths are in LMICs.
The World Health Organization (WHO) recommends the combination of ampicillin plus gentamicin for empiric treatment of neonatal sepsis. But the first BARNARDS study, conducted from 2015 through 2018, found extremely high rates of resistance to the combination therapy, raising questions over whether the WHO should revise its recommendations.
The findings from BARNARDS II, a prospective study led by researchers from the University of Oxford’s Ineos Oxford Institute (IOI), are no different. Of the 14,259 newborns treated empirically for suspected sepsis from February 2024 to October 2025 at 13 neonatal units in the three countries, only 40 received the ampicillin-gentamicin combination. Analysis of 2,821 culture-confirmed cases with pathogen identification and antibiotic-susceptibility data found that ampicillin-gentamicin would have been active against only 25% of those cases.
“In these settings, ampicillin and gentamicin would have provided limited coverage against the locally prevalent, highly resistant pathogens,” lead author Kathryn Thomson, PhD, of IOI, said in an ESCMID press release yesterday.
Thomson and her colleagues said the limited ineffectiveness of ampicillin and gentamicin explains why clinicians opted for other two-drug combinations, most frequently amikacin plus cefotaxime.
“Rather than reflecting poor adherence to guidelines, this likely represents adaptation to local resistance patterns and the challenges of applying global treatment recommendations in these environments,” she said.
No ‘one-size-fits-all’ approach
Still, only 37% of the culture-confirmed sepsis case-patients received appropriate empiric therapy, which was associated with a 17.9% mortality rate. Mortality for inappropriate empiric therapy was nearly twofold higher (32.1%) in the unadjusted analyses, but adjusted analysis found that underlying clinical factors, primarily gestational age, were largely responsible for the higher mortality rate.
The authors note that one of the problems with the WHO recommendation for empiric treatment of neonatal sepsis is that it’s based on data from high-income countries, and the distribution of pathogens and patterns of antimicrobial resistance (AMR) are much different in LMICs. Treatment needs to be administered within hours to prevent tissue damage, organ failure, and death in newborns, who are highly vulnerable to drug-resistant infections, but clinicians in LMICs have limited local data to guide appropriate antibiotic therapy.
In these settings, ampicillin and gentamicin would have provided limited coverage against the locally prevalent, highly resistant pathogens.
Co-author Timothy Walsh, DSc, also of IOI, said the findings show that the “one-size-fits-all” approach for neonatal sepsis treatment guidelines is “unlikely to be effective globally.”
“Even across the countries included in this study, we observed important differences in both the pathogens responsible for infection and their resistance profiles,” Walsh said.
Walsh added that improving neonatal sepsis outcomes in LMICs will require locally informed empiric treatment strategies, enhanced diagnostics, continued AMR surveillance, and sustainable access to effective antibiotics.