Condition category
Infections and Infestations
Date applied
27/05/2017
Date assigned
26/07/2017
Last edited
26/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Staphylococcus aureus is a bacterium that is carried by 30% of humans, mainly in the nose and on the skin. Humans and S. aureus generally co-exist well. Sometimes, S. aureus may cause an infection, such as wound infections after surgery. These infections can be treated with antibiotics. During the last decades, the amount of S. aureus that is resistant to many of the antibiotics used to treat infections, the so-called MRSA (methicillin-resistant S. aureus) has increased, both in the community and hospital setting. Although the frequency varies among regions and countries, MRSA has been found worldwide. The burden of disease, however, seems to be higher in developing countries compared to developed countries. Effective actions to prevent or reduce the spread of MRSA within healthcare facilities have been conducted in several developed countries. However, the preventive actions have not been implemented in healthcare settings in resource-limited countries, since other healthcare issues such as HIV/AIDS, malaria, and tuberculosis are commonly prioritized on the public health care agendas in these countries. Active actions to prevent MRSA transmission (spreading) could reduce the amount of MRSA infections in developing countries such as Indonesia. The aim of this study is to design feasible actions to prevent further transmission of MRSA in the surgery ward of the Dr. Saiful Anwar Hospital in Malang, Indonesia, and to measure the effect of introducing these preventive measures on the transmission and acquisition of MRSA.

Who can participate?
All patients admitted to the study rooms in the surgery ward.

What does the study involve?
Participating patients and healthcare workers are screened for MRSA. Patients are screened for MRSA at admission to the hospital, day five of hospitalization, and at discharge. This is done through swabs of the nose, throat and open skin areas. Participating healthcare workers are screened twice through swabs of the nose, throat and skin lesions. Preventative measures are introduced to the hospital to reduce the level of MRSA transmission. These include hand washing education, treating MRSA positive participants with a decolonization therapy (a therapy body wash and nasal ointment to get rid of any MRSA) and cleaning the surgery ward twice. Participants are rescreened again for MRSA to see if the MRSA rates have been reduced.

What are the possible benefits and risks of participating?
Participants may benefit from being identified that they carry MRSA and being offered eradication therapy to prevent infections. This can also decrease the risk of transmission. Some risks involved in the study include reactions to the swabs (sneezing, gaggin, irritation) as well as sensitivity to the decolonization therapy.

Where is the study run from?
This study is being run by Erasmus University Medical Center (Netherlands) and takes place in the Dr Saiful Anwar hospital (Indonesia)

When is the study starting and how long is it expected to run for?
January 2012 to April 2017

Who is funding the study?
Erasmus University Medical Center (Netherlands)

Who is the main contact?
Dr Juliette Severin
j.severin@erasmusmc.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Juliette Severin

ORCID ID

Contact details

Department of Medical Microbiology and Infectious Diseases
Erasmus University Medical Center
‘s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 10 703 35 10
j.severin@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRSA2012/FKUB-RSSA

Study information

Scientific title

Intervention study for the containment of methicillin-resistant Staphylococcus aureus (MRSA) in a surgical ward of a low resource hospital in Indonesia

Acronym

Study hypothesis

The aim of this study is to design feasible actions to prevent further transmission of MRSA in the surgery ward of the Dr. Saiful Anwar Hospital in Malang, Indonesia, and to measure the effect of introducing these preventive measures on the transmission and acquisition of MRSA.

Ethics approval

Medical Ethics Committee of Dr. Saiful Anwar hospital, Malang, Indonesia, 09/05/2012, ref: 129/EC/KEPK-JK/05/2012

Study design

Interventional non randomised single-centre cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

MRSA

Intervention

This study consists of three phases and takes place over a period of 24 weeks.

Phase 1: Pre-intervention phase (ten weeks)
During the first phase screening of patients, health-care workers and the environment are screened to monitor the epidemiology of S. aureus on the surgery ward. Screening of patient is conducted three times: at admission, at day five of hospitalisation, and at discharge by culturing swabs of anterior nares, throat, and open skin lesion (if present). When a patient is still hospitalised at the end of the phase 1, they are screened again at the end of this phase. Screening of healthcare workers and the environment is conducted twice: at the beginning and at the end of this phase. Also, the rate of compliance of the healthcare workers with the World Health Organization (WHO) guidelines for hand hygiene is measured. The compliance of the healthcare workers with the guidelines from the WHO for hand hygiene is observed repeatedly throughout the study. During these observations the observers (2 Indonesian students and 2 Dutch students, all trained) use the five moments of hand hygiene as defined by the WHO and counted the times the healthcare workers performed proper hand hygiene during these moments as they occurred. The five moments of hand hygiene according to the WHO are:
1. Before touching a patient.
2. Before a clean or aseptic procedure.
3. After body fluid exposure risk.
4. After touching a patient.
5. After touching patient surroundings (for example after touching the bed or table of a patient).
The observation is conducted two to three times per day to get enough observation moments.

Phase 2: Intervention phase (four weeks):
During this phase a bundle of preventive measures will be introduced in the ward in order to lower the acquisition rate of MRSA among patients and healthcare workers and to reduce the level of contamination of the environment with MRSA. Also, an educational program will be undertaken to improve compliance of the nursing staff with hand hygiene guidelines.

The bundle of preventive actions consists of:
1. An hand-hygiene educational program, as part of the preventive measures, was undertaken to improve the compliance of healthcare workers with the hand hygiene guideline and included weekly presentations, distribution of information sheets and leaflets, and hanging large posters in the ward. In addition, we installed a bottle of 500 ml chlorhexidine-containing hand glycerin alcohol 0.5% at each bedside, and teaching the healthcare workes about proper hand hygiene according to WHO guideline
2. Cohorting all MRSA-positive patients behind a screen
3. Treating all MRSA-positive patients and healthcare workers with a decolonization therapy consisting of mupirocin dermatological cream 2% (Bactoderm cream, PT. Ikapharmindo Putramas, Indonesia) to both nares twice daily for five days plus chlorhexidine medicated soap 4% (Hibiscrub, Astra Zeneca) for 7 days. Patients and healthcare workers who carried MRSA in their throat were offered trimethoprim/sulfamethoxazole oral therapy 960 mg 2 twice daily
4. Cleaning and disinfecting the environment of the surgery ward twice, once at the beginning and once at the end of this phase using sodium hypochlorite 0.05% (for surfaces) and alcohol 70% (for instruments)

During this period the screening of MRSA is continued for patients. Healthcare workers and the environment are screened once at the beginning of this phase. When a patient is still hospitalized at the end of phase 2, he/she will be screened again at the end of this phase. Hand hygiene compliance will not be measured during this phase, since the researchers will be actively involved in instructing the healthcare workers to perform proper hand hygiene at the appropriate times.

Phase 3: Post-intervention phase (ten weeks):
During the last phase the epidemiology of S. aureus and compliance to hand hygiene guidelines in the surgery ward is monitored as described for Phase 1 in order to observe the effects of the implemented preventive measures.

During the study period the methicillin-resistant S. aureus (MRSA) and methicillin-sensitive S. aureus (MSSA)-acquisition rate among patients, the number of MRSA and MSSA positive healthcare workers, and the level of contamination of the environment with MRSA or MSSA are measured

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

MRSA acquisition rate is measured by dividing the number of acquisition events of MRSA by the number of patient-days at risk in 1000 patient days.

Secondary outcome measures

1. Compliance rate for hand hygiene is assessed as the percentage of correct hand hygiene actions undertaken on moments when hand hygiene was considered necessary according to the WHO “five moments" at the pre-intervention phase and post-intervention phase.
2. Environmental contamination rate of MRSA is assessed as the percentage of environmental samples showing MRSA positive cultures on two screening moments in both the pre-intervention phase and post-intervention phase.

Overall trial start date

20/01/2012

Overall trial end date

23/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients admitted to the study rooms in surgery ward
2. Patients with complete culture sets, i.e. nose and throat swab taken on admission and either at day-5 hospitalization or at discharge (or both)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450 patients per each phase

Participant exclusion criteria

Patients leaving the room within 48 hours of admission.

Recruitment start date

03/07/2012

Recruitment end date

22/08/2013

Locations

Countries of recruitment

Indonesia

Trial participating centre

Dr. Saiful Anwar Hospital
Jalan Jaksa Agung Suprapto No. 2
Malang
65111
Indonesia

Sponsor information

Organisation

Erasmus University Medical Center

Sponsor details

Department of Medical Microbiology and Infectious Diseases
‘s-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 10 703 35 10
j.severin@erasmusmc.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus University Medical Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned to submit the manuscript to Infection Control and Hospital Epidemiology in October 2017.

IPD sharing statement:
The datasets generated during and/or analyzed during the current study are/will be available upon request from dewi_santosa@yahoo.com

Intention to publish date

31/10/2017

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes