Extended antibiotic use creates a cascade of problems. Long or unnecessary antibiotic exposure increases the risk of bacteria developing resistance. These resistant organisms can spread within hospitals and make future infections harder to treat.
Published Nov 01, 2025 | 9:00 AM ⚊ Updated Nov 01, 2025 | 9:00 AM
Synopsis: Shorter antibiotic courses of around seven days can effectively treat many serious infections in newborns without increasing the risk of death or relapse, a landmark new study has found. The findings, drawn from a large Indian-led analysis of international trials, challenge decades of routine practice prescribing ten- to fourteen-day treatments. The researchers say the shorter course could help curb antibiotic resistance and improve care in resource-limited neonatal units.
When a newborn develops a serious infection, antibiotics can mean the difference between life and death. But one question has long divided neonatologists: how long should these life-saving drugs be given?
For decades, the answer has remained the same – ten to fourteen days for blood infections, and sometimes even longer. Yet this approach is not based on rigorous scientific evidence, but rather on a long-standing practice of erring on the side of caution.
Now, a team of Indian neonatologists has found evidence that shorter courses of antibiotics may be just as effective as the standard longer treatments for many common and serious infections in newborns.
The study was a collaboration among seven Indian institutions: the Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh, Surya Hospitals in Mumbai, Kasturba Medical College in Manipal, King Edward Memorial Hospital in Pune, Chettinad Hospital and Research Institute in Chennai, Government Medical College in Chandigarh, and Fernandez Hospital in Hyderabad. Their findings were published in the journal eClinicalMedicine.
“Many newborn infections can be treated with shorter antibiotic courses,” said Dr Saikiran D, Consultant Neonatologist at the Hyderabad-based Fernandez Hospital and a member of the research team, in an interview with South First.
Dr Saikiran said that doctors have long suspected shorter antibiotic courses might work, but lacked the rigorous evidence needed to change practice – until now.
The researchers conducted systematic reviews and meta-analyses of randomised controlled trials published between January 1990 and December 2024. They searched MEDLINE, EMBASE and the Cochrane Library, reviewing 19,541 records before selecting 26 studies that met their criteria.
“We conducted systematic reviews and meta-analyses to determine whether short-course antibiotics are noninferior to ‘standard’ courses for culture-positive sepsis, culture-negative sepsis, UTIs, uncomplicated or complicated meningitis, and fungal sepsis,” the study explains.
The team addressed seven clinical questions, examining whether shorter courses matched standard ones for different types of infections. They also studied strategies based on biomarkers, which help doctors assess whether an infection is resolving and decide when to stop antibiotics.
“Certain blood tests indicate the presence of infection, and these clues are called biomarkers,” the study explains, making the complex science accessible to clinicians and families alike.
Dr Saikiran added that the new approach could help fight antibiotic resistance, reduce hospital infections and improve resource use, especially in settings with high patient loads or limited facilities.
In most hospitals today, antibiotic durations follow routine practice rather than data. A newborn with sepsis typically receives antibiotics for ten to fourteen days, even if recovery occurs earlier. This cautious approach evolved to prevent relapse or death, but it carries hidden costs.
“Evidence-based guidance on antibiotic durations for treating neonatal infections is lacking,” the study notes. “Noninferiority meta-analyses evaluating shorter durations or biomarker-guided durations have not been conducted.”
Extended antibiotic use creates a cascade of problems. Long or unnecessary antibiotic exposure increases the risk of bacteria developing resistance. These resistant organisms can spread within hospitals and make future infections harder to treat. Neonatal intensive care units (NICUs) are particularly vulnerable to such outbreaks.
The study emphasises that while antibiotics save lives, using them too often or for too long fuels antibiotic resistance, making infections harder to treat. “It also exposes vulnerable newborns to side effects, longer hospital stays, and higher costs. Premature and sick newborns receive antibiotics more frequently and for longer periods than older children and adults,” the researchers state.
Prolonged treatment means newborns remain on antibiotics longer than necessary, which can disrupt their gut microbiome, increase side effects and complicate care. The very drugs that save lives can also cause harm when used excessively.
“Unnecessary antibiotic prolongation promotes antimicrobial resistance,” the authors write, highlighting a problem that extends far beyond individual patients to affect entire healthcare systems.
The study’s key findings indicate that about seven days of antibiotics may be sufficient in most cases, instead of the usually recommended ten to fourteen days, without added risk. Stopping treatment when biomarker blood tests turn negative typically results in shorter courses that remain effective and adequate for many newborn infections.
“Compared to standard durations, seven to ten-day antibiotic courses and biomarker-guided courses may be noninferior for treating culture-positive neonatal sepsis and any sepsis, respectively,” the researchers conclude.
However, evidence comparing antibiotic courses of three to four days versus five to seven days remained unclear. “For culture-negative sepsis, shorter courses (three to four days) were noninferior for culture-positive relapses but not noninferior for other outcomes,” the study notes, highlighting the need for further research.
For urinary tract infections, six observational studies showed no significant difference in relapse rates between shorter and longer antibiotic courses. However, “conclusions could not be drawn for UTI or meningitis,” the authors state, citing the lack of reliable randomised evidence.
Only one trial examined meningitis, and no eligible studies existed for complicated meningitis or fungal sepsis. “There were no data for complicated meningitis and fungal sepsis,” the researchers report, pointing to areas where standard long-duration therapy must continue.
Seven randomised controlled trials compared shorter (seven to ten-day) and standard (ten to fourteen-day) antibiotic courses for blood culture-positive sepsis. The results showed that shorter courses carried no higher risk of death or relapse of infection compared with longer ones.
The upper limits of the confidence intervals for risk differences stayed below the pre-specified margins for mortality (one percent) and relapse (three to five percent), meeting the definition of non-inferiority. Shorter courses also reduced total antibiotic use and shortened hospital stays by about three to five days.
Five trials compared biomarker-guided antibiotic discontinuation—using markers such as C-reactive protein or procalcitonin—to standard fixed-duration therapy. Results showed that biomarker-guided stopping carried no association with higher mortality or relapse rates. Antibiotic duration and hospitalisation times were slightly shorter in the biomarker-guided groups.
For suspected but culture-negative sepsis, six trials compared short (three to four-day) and standard (five to seven-day) courses. No deaths occurred in any of the studies. However, the data could not confirm that very short courses are as safe as longer ones.
The researchers stressed that these findings apply to neonates who show clear clinical improvement during treatment. For severe or complicated infections, longer treatment remains recommended until further data become available.
“We conducted a collection of meta-analyses addressing seven related PICO questions comparing various durations of antimicrobials and biomarker-guided versus standard durations in serious neonatal infections,” the authors stated. “Across the meta-analyses, high risk of bias was prevalent.”
However, they acknowledged limitations in their work: “Few original trials were explicitly conducted as noninferiority trials, and the sample sizes generally fell short of the respective optimal information sizes.”
The certainty of evidence varied across different infection types. “For most outcomes, the certainty of evidence (CoE) was low to very low, which reflected high risk of bias and small sample sizes,” the study notes, urging caution in interpretation.
The findings hold relevance for hospitals worldwide, especially in low- and middle-income countries where antibiotic resistance is a major public health concern and neonatal infections remain a leading cause of death.
“Most studies on antibiotic duration for culture-positive sepsis, culture-negative sepsis, and meningitis were conducted in India. Given the distinct pathogen profile and high AMR prevalence in India, generalisability to high-income countries may be limited,” the authors acknowledge, while noting the broader implications.
The study compiled evidence from multiple randomised controlled trials and explicitly applied non-inferiority standards. “To the best of our knowledge, our meta-analyses are the first in this field to explicitly address noninferiority questions,” the researchers state, marking a methodological advance.
If confirmed by further research, the findings could help shape hospital policies on antibiotic stewardship.
“It is possible to safely use shorter antibiotic courses for proven blood infections in newborns, and if widely adopted, it could help fight antibiotic resistance, reduce hospital infections, and improve resource use, especially in hospital settings that have patient overload or limited facilities,” the study adds.
(Edited by Dese Gowda)
