Clinical trial NCT02401204: Bacterial Transmission Dynamics Study
Official title: Bacterial Transmission Surveillance in Neonatal Intensive Care Unit: Transmission Dynamics and Drug Resistance Patterns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Transmission Surveillance
Neonatal Intensive Care Unit
Drug Resistance
Keywords: Bacterial transmission
Surveillance
Neonatal
Drug Resistance
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mahidol Oxford Tropical Medicine Research Unit
name: Queen Sirikit National Institute of Child Health
First posted: 2015-03-27
Enrollment: 97
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates up to one month old

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

• There are no exclusion criteria for this study

Primary outcomes:
measure: Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.
timeFrame: During admission in NICU unit
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Queen Sirikit National Institute of Child Health
state: Bangkok
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit
name: Ben Cooper, Dr.
role: PRINCIPAL_INVESTIGATOR
References: