Hospital-acquired infections and antibiotic drug resistance in a Vietnamese hospital

ISRCTN	ISRCTN08535695
DOI	https://doi.org/10.1186/ISRCTN08535695
Secondary identifying numbers	ctu04avjun08

Submission date: 16/07/2008
Registration date: 17/07/2008
Last edited: 14/11/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
As healthcare around the world improves and more people are given access to treatment, two new problems emerge: the problem of nosocomial infections and the problem of antimicrobial resistance. Nosocomial infections, also known as hospital-acquired infections, are diseases that are more likely to happen in a hospital environment. They can be diseases that are circulating among doctors, nurses and hospital staff that then get passed on to patients, or diseases that are just more likely to strike people who are already sick. Antimicrobial resistance is the phenomenon of bacteria becoming resistant to the drugs used against them. When an antibiotic drug is used, the bacteria who are resistant will survive and go on to reproduce, while the bacteria who are not resistant perish, so in the end only the bacteria who are resistant remain circulating among people. These two problems are predicted to become increasingly important in Vietnam in the coming years. Advances in hospital care mean patients will come to hospitals more frequently and stay at hospitals longer each time, meaning they will be more exposed to environments in which nosocomial infections occur. Improved access to treatment means more patients will be given antibiotic drugs, increasing the likelihood of bacteria becoming resistant. This study aims to look at how often nosocomial infections occur, as well as how much of the bacteria circulating currently are drug-resistant.

Who can participate?
Patients were recruited to the study from the intensive care unit (ICU) of the National Institute of Infectious and Tropical Diseases (NIITD). Recruited patients had to be adults over 16 years old and had to provide informed consent.

What does the study involve?
This was an observational study, so patients were not given new or extra treatments, they were simply observed and analyzed. Study doctors would take swabs from a patient on admission to the ICU and once per week until discharge. The samples would be stored and analyzed for development of nosocomial infections or antimicrobial resistance.

What are the possible benefits and risks of participating?
The patient may benefit from the study because more intensive investigations are being done which may allow to detect and treat an infection earlier than otherwise. This research involves several tests that are done routinely in these hospitals. There are no major risks. The swabs may cause some slights discomfort but otherwise will cause the patient no harm. Some people may find the weekly visits until discharge inconvenient. There will be no additional costs to the patient if they participate in this study. The study investigators will cover all the costs of any tests undertaken as part of the study.

Where is the study run from?
This study was planned by researchers at the Oxford University Clinical Research Unit in Vietnam, in partnership with the National Institute of Infectious and Tropical Diseases.

When is the study starting and how long is it expected to run for?
Unfortunately this study could not be conducted and no patients were enrolled.

Who is funding the study?
The Wellcome Trust (UK).

Who is the main contact?
Clinical Trials Unit at the Oxford University Clinical Research Unit in Vietnam
Tel: +84 839 241 983

Contact information

Dr Heiman Wertheim
Scientific

National Institute of Infectious and Tropical Diseases (NIITD)
78 Giai Phong Street
Hanoi
-
Viet Nam

Phone	+84 4 576 4320
Email	hwertheim@oucru.org

Study information

Study design	Observational descriptive cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Antimicrobial resistance and nosocomial infections at the Intensive Care Unit of the National Institute of Infectious and Tropical Diseases (NIITD), Hanoi: an observational study
Study objectives	To study the pattern and burden of antimicrobial resistance and nosocomial infections in the intensive care unit of National Institute of Infectious and Tropical Diseases (NIITD).
Ethics approval(s)	Ethics approval pending as of 16/07/2008 from: 1. Oxford Tropical Medicine Research Ethics Committee (OXTREC) (UK) 2. NIITD Ethical Committee (Viet Nam)
Health condition(s) or problem(s) studied	Nosocomial infections
Intervention	The study investigations will consist of bacterial culture from nose swabs, rectal swabs and sputum on admission and once per week until discharge to monitor development of antibiotic resistance. If other specimens for bacterial culture are taken for clinical reasons, these results will be entered onto the database. These specimens will also be stored. Updated 14/11/2013: This study was never conducted as local approval could not be obtained.
Intervention type	Other
Primary outcome measure	1. Proportion of patients colonised with resistant bacteria on admission 2. Rate of acquisition of resistant bacteria during admission 3. Incidence of nosocomial infections (nosocomial infections under investigation are: pneumonia, blood stream infection, urinary tract infection and Clostridium difficile diarrhoea)
Secondary outcome measures	Compare patient characteristics between: 1. Patients who develop nosocomial pneumonia versus those who do not 2. Patients who develop nosocomial blood stream infection versus those who do not 3. Patients who develop nosocomial urinary tract infection versus those who do not 4. Patients who develop Clostridium difficile associated diarrhoea versus those who do not, and 5. Patients with resistant bacteria versus those without
Overall study start date	01/11/2008
Completion date	01/11/2010
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	500
Key inclusion criteria	1. Adult patients, including pregnant women, admitted to the intensive care unit of NIITD 2. Aged over 16 years, both male and female 3. Informed consent signed by the patient or his/her legal guardian
Key exclusion criteria	Absence of informed consent
Date of first enrolment	01/11/2008
Date of final enrolment	01/11/2010

Locations

Countries of recruitment

Viet Nam

Study participating centre

National Institute of Infectious and Tropical Diseases (NIITD)

Hanoi
-
Viet Nam

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom

Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Charity

The Wellcome Trust (UK) (grant ref: 077078)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan