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Bacterial Transmission Dynamics Study

Bacterial Transmission Surveillance in Neonatal Intensive Care Unit: Transmission Dynamics and Drug Resistance Patterns

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02401204
Acronym
BTS
Enrollment
97
Registered
2015-03-27
Start date
2015-02-28
Completion date
2019-05-31
Last updated
2019-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Transmission Surveillance, Drug Resistance, Neonatal Intensive Care Unit

Keywords

Bacterial transmission, Surveillance, Neonatal, Drug Resistance

Brief summary

Infections with multiply antibiotic-resistant bacteria represent a major cause of preventable morbidity and mortality amongst hospitalized neonates worldwide. In Southeast Asia, where antibiotic-resistance is a major problem, Gram-negative bacteria account for the majority of such infections. The most common pathogens are Acinetobacter spp., Pseudomonas aeruginosa, Enterobacter spp., Escherichia coli and Klebsiella pneumonia. The great majority of infections with these pathogens represent asymptomatic carriage, though in the absence of routine screening for asymptomatic carriage reliable estimates of the prevalence, rates of transmission between patients, and rates of importation from the community are lacking. Moreover, current understanding of the degree and manner in which different antibiotics act to select for such resistant organisms is rudimentary.

Detailed description

Objectives: To quantify the prevalence of drug-resistant Gram-negative pathogens on admission to a neonatal intensive care unit and during subsequent days of hospital stay. To quantify rates of patient-to-patient transmission for key organisms, to characterize how patient antibiotic use impacts on the ward-level dynamics of such organisms. Methods: All infants admitted to the unit over a period of one year for whom the parent/guardian gives informed consent will be included. In addition to routine demographic and clinical data for included patients, full patient-level data on antibiotic use within the ward will also be recorded. Carriage of resistant Gram-negative organisms will be determined though rectal swabs, tracheal aspirates (for ventilated patients) and stool samples taken on admission and at twice weekly intervals. Antibiotic-resistant Gram-negative bacteria will be cultured and their resistant patterns determined. Selected environmental surfaces will also be sampled to detect contamination with such organisms. For the most important organisms (Acinetobacter spp. and Klebsiella spp.) whole genome sequencing will be used in conjunction with Bayesian data augmentation techniques to determine transmission pathways and the impact of antibiotic use on the transmission and persistence of such organisms within the hospital ward.

Interventions

OTHERLongitudinal surveillance study

Regular specimens will be routinely collected as standard of practice. A rectal swab and stool specimen will be collected twice a week since first admission on NICU until discharge from NICU. If participant is intubated/ventilated, a throat swab will be collected.

Sponsors

Mahidol Oxford Tropical Medicine Research Unit
CollaboratorOTHER
Queen Sirikit National Institute of Child Health
CollaboratorOTHER_GOV
University of Oxford
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 1 Months
Healthy volunteers
No

Inclusion criteria

* All neonates admitted to QSNICH NICU * Parent/legal guardian gives written informed consent

Exclusion criteria

• There are no

Design outcomes

Primary

MeasureTime frame
Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.During admission in NICU unit

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026