Bacterial Transmission Dynamics Study

Drug Resistance Clinical Trial

— BTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401204
• Other study ID #: MODEL1402
• Status: Completed
• Start date: February 2015
• Est. completion date: May 2019

Study information

• Verified date: September 2019
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Transmission Surveillance
• Drug Resistance
• Neonatal Intensive Care Unit

Intervention

Other:
• Longitudinal 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.

Locations

Country	Name	City	State
Thailand	Queen Sirikit National Institute of Child Health	Ratchathewi	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Mahidol Oxford Tropical Medicine Research Unit, Queen Sirikit National Institute of Child Health

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of neonates who acquired infection from each expected pathogens during admission in NICU unit.		During admission in NICU unit