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Turning the tide of antimicrobial resistance in intensive care units in Indonesia


- candidate number23527
- NTR NumberNTR5541
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-dec-2015
- Secondary IDs561/PT02.FK/ETIK/2012  The Ethics Committee of the Faculty of Medicine, Universitas Indonesia
- Public TitleTurning the tide of antimicrobial resistance in intensive care units in Indonesia
- Scientific TitleTurning the tide of antimicrobial resistance in intensive care units in Indonesia
- ACRONYM
- hypothesisA bundle of inexpensive interventions can reduce the emergence and spread of carbapenem non-susceptible Gram-negative bacteria in a low-resource ICU.
- Healt Condition(s) or Problem(s) studiedAntimicrobial resistance , Intensive care
- Inclusion criteriaAll adult patients (age more than 16 years old) admitted to the intensive care unit of Dr Cipto Mangunkusumo Hospital in Jakarta, Indonesia.
- Exclusion criteriaPatients who are discharged within 48 hours from the intensive care unit.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-apr-2013
- planned closingdate31-dec-2015
- Target number of participants550
- Interventions1.Contact Isolation Precautions for patients colonized or infected with a carbapenem non-susceptible Gram-negative bacterium (Pseudomonas aeruginosa, Klebsiella pneumoniae, or Acinetobacter baumannii).
2.Cohorting patients with a carbapenem non-susceptible Gram-negative bacterium (Pseudomonas aeruginosa, Klebsiella pneumoniae, or Acinetobacter baumannii).
3.Source control, for all included patients:
a. Bathing: once daily with chlorhexidine 2%
b. Oral hygiene for intubated patient⇒ 4 times daily --> 2% solutions of chlorhexidine
4. Environmental cleaning
5. Antibiotic Stewardship
- Primary outcomeThe number of patients who acquire carriage or infection with A. baumannii with reduced susceptibility to carbapenems, P. aeruginosa with reduced susceptibility to carbapenems, or K. pneumoniae with reduced susceptibility to carbapenems per 100 patient-days at risk in the ICU.
An acquisition is defined as a screening culture (throat or rectum) or clinical culture with a first detection of either A. baumannii, P. aeruginosa, or K. pneumoniae, all with reduced susceptibility to a carbapenem, that was not yet present on admission or in the first 48 hours of admission. Thus, for each patient, a maximum of three new acquisition events may occur.
- Secondary outcomeMeasures include quantity and quality of antibiotic usage, the in-ICU crude mortality rate, the hand hygiene compliance of health care workers, and environmental contamination of the above mentioned Gram-negative bacteria with reduced susceptibility to carbapanems.
- TimepointsStool or rectum samples and throat samples will be obtained from patients on the ICU on admission, then weekly until discharge from the ICU and on discharge.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Juliette Severin
- CONTACT for SCIENTIFIC QUERIESProf dr Henri A. Verbrugh
- Sponsor/Initiator Faculty of Medicine Universitas Indonesia, Dr Cipto Mangunkusumo Hospital Jakarta, Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Directorate General of Higher Education (DGHE) of Indonesia
- PublicationsN/A
- Brief summaryAntimicrobial resistance of bacteria has emerged worldwide as a major health care problem, but particularly emerges in and affects low-resource countries. It is in the interest of global health that antimicrobial resistance is addressed and combated with a focus on interventions in developing countries. Intensive care units (ICUs) are a hot-spot for the emergence of extremely-drug resistant Gram-negative bacteria. In a pilot study in the ICU of the Dr. Cipto Mangunkusumo Hospital in Jakarta, Indonesia, it was shown that multidrug-resistant (MDR) Pseudomonas aeruginosa, MDR Acinetobacter baumannii, and carbapenem-resistant Klebsiella pneumoniae were prevalent. Containment strategies such as those recommended by the Centers for Disease Control and Prevention (CDC) are, however, difficult to apply because of constrained budgets that demand prioritisation. In our research project we will implement a set of inexpensive interventions on a ICU in Indonesia, and monitor the effect of these interventions in a before-and-after study with a baseline period of 10 months (phase I), a period for the implementation of the bundle of interventions of 2 months (phase II), and an after period of 10 months (phase III). The target microorganisms will be P. aeruginosa, A. baumannii, and K. pneumoniae, all with reduced susceptibility to carbapenem antibiotics. The primary outcome will be the number of patients who acquire carriage or infection with one of the three target microorganisms per 100 patient-days at risk in the ICU.
Our study will result in a scientifically based, efficient strategy to limit the emergence of resistance bacteria in Indonesian ICUs. This programme could be the starting point for a nationwide action in Indonesian ICUs. The results of our study will also be useful for ICUs in other low-resource countries.
- Main changes (audit trail)
- RECORD22-dec-2015 - 31-jan-2016


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