Rapid Molecular Test to Detect Bloodstream Infection in Newborns and Children Suspected of Sepsis

What this Trial Is About

Babies and children are at risk of bloodstream infections called sepsis, which can be hard to diagnose because symptoms are often unclear and common in non-sick children. This research is evaluating whether Molecular Culture, a PCR-based test that identifies bacterial pathogens within 4 hours, is more accurate than traditional blood culture methods for diagnosing sepsis in newborns and children. The study aims to reduce unnecessary antibiotic use, which can harm beneficial gut bacteria and contribute to antibiotic resistance. The study observes children from newborns up to 18 years old who undergo blood collection for conventional culture as part of their standard care. Molecular Culture uses DNA profiling with specific PCR primers to detect a wide range of bacteria quickly, unlike the slower conventional blood culture which can take 36 to 72 hours. Several groups in the study include early-onset sepsis, late-onset sepsis, and children receiving follow-up blood tests after antibiotic initiation to compare diagnostic accuracy. Participants will have blood samples taken for both Molecular Culture and conventional blood culture, with results compared up to two weeks after sampling. Researchers will assess how well Molecular Culture detects bacteria and clinical sepsis compared to traditional methods. The study includes monitoring antibiotic use and clinical outcomes, aiming to improve early detection and guide faster decisions about starting or stopping antibiotics in children suspected of sepsis.

Molecular Culture for the Diagnosis of Pediatric Sepsis