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Ralstonia pickettii outbreak in pediatric intensive care units, Peru-2025
Medalit Luna-Vilchez1,2, Mitsi Lorraine Santiago Abal3, Humania Aguirre Chávez3
1Unidad de Atención Integral Especializada, https://ror.org/03yhwzd24Instituto Nacional de Salud del Niño San Borja, Lima, Perú.
Objective:
Ralstonia spp. are opportunistic gram-negative bacilli that persist in aqueous environments and may cause nosocomial outbreaks. We describe an outbreak of bloodstream infections by Ralstonia pickettii associated with contaminated dexmedetomidine.
Methods:
Outbreak investigation, including a case-control study, was conducted in a tertiary pediatric hospital (July 19-August 23, 2025), affecting the Cardiovascular, Pediatric, and Burn Intensive Care Units. Species identification was performed using MALDI-TOF MS. Whole-genome sequencing evaluated clonality and phylogenetic relationships with previously reported outbreaks. Environmental sampling and traceability of medical products identified the outbreak source.
Results:
Eleven R. pickettii bloodstream infections were identified, with 72.73% occurring in the Cardiovascular ICU. The median patient age was 6 months (IQR: 2 mo-7 yr), and fever was the predominant symptom (72.73%). The attack rate was 29.73%, and the case fatality rate was 27.27%. Significant risk factors included exposure to the implicated dexmedetomidine batch (OR 18.75, 95% CI 2.02-173.00, P = .01) and higher dispensed quantity of dexmedetomidine (OR 1.33, 95% CI 1.07-1.67, P = .01). Genomic analysis confirmed clonal R. pickettii (rST-37,889) with close phylogenetic relatedness to outbreaks in Germany and Australia in 2023. All isolates harbored blaOXA-60, blaOXA-22, adeF, and vanH resistance genes. Identical R. pickettii was isolated from the implicated imported dexmedetomidine batch. The outbreak was controlled following withdrawal of the contaminated batch.
Conclusions:
This first reported outbreak of R. pickettii bloodstream infections linked to intrinsically contaminated dexmedetomidine highlights risks from manufacturing failures in global pharmaceutical supply chains and emphasizes the essential role of genomic surveillance in outbreak investigation.
Insights
A Ralstonia pickettii outbreak in a pediatric hospital was linked to contaminated dexmedetomidine. Genomic surveillance identified the source, leading to successful control by withdrawing the affected batch.
Area of Science:
- Medical Microbiology
- Infectious Diseases
- Public Health
Background:
- Ralstonia spp. are opportunistic gram-negative bacilli found in aqueous environments.
- Nosocomial outbreaks caused by Ralstonia spp. pose a significant threat in healthcare settings.
- Dexmedetomidine is a commonly used sedative and analgesic in pediatric intensive care.
Purpose of the Study:
- To describe an outbreak of Ralstonia pickettii bloodstream infections.
- To identify the source and risk factors associated with the outbreak.
- To evaluate the role of genomic surveillance in outbreak investigation.
Main Methods:
- An outbreak investigation including a case-control study was conducted in a tertiary pediatric hospital.
- Species identification was performed using MALDI-TOF MS.
- Whole-genome sequencing and environmental sampling were utilized to identify the outbreak source and clonality.
Main Results:
- Eleven Ralstonia pickettii bloodstream infections were identified, primarily in the Cardiovascular ICU.
- Exposure to a contaminated dexmedetomidine batch was a significant risk factor (OR 18.75).
- Genomic analysis confirmed clonal R. pickettii linked to contaminated dexmedetomidine, with identical bacteria isolated from the drug batch.
Conclusions:
- This outbreak highlights the risk of intrinsically contaminated pharmaceuticals in global supply chains.
- Manufacturing failures can lead to severe nosocomial infections.
- Genomic surveillance is crucial for effective outbreak investigation and control.
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