Antibiotic Resistant InfectionNCT05293483
The Impact of Covid-19 Hospital Care on the Prevalence of MDRO in Indonesia
An observational study of Antibiotic Resistant Infection and COVID-19, run by Erasmus Medical Center at 2 sites in Indonesia.
Trial summary
The effect of the COVID-19 pandemic on the emergence and spread of antibiotic-resistant bacteria is largely unknown, especially in low-resource settings. We aim to investigate the prevalence and relatedness of multidrug-resistant bacteria among patients in both COVID-19 and non-COVID-19 wards in two hospitals in… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Antibiotic Resistant Infection, COVID-19
- How many people
- 1,110 participants
- Where
- 2 sitesIndonesia
- Study dates
- 7 Mar 2022to 7 Mar 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients will be actively screened for MDRO carriage on the day of discharge and 30 days post-discharge from the COVID-19 ward and the non-COVID-19 ward (ICU and internal medicine wards)
Who may be able to join
- All adult patients discharged from Covid wards and non Covid wards (ICU and internal medicine wards)
Who cannot join
- Patients discharged within 48 hours of admission
- Patients who either live outside the city of Malang or their address is unclear
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites, 2 recruiting
- Not yet recruiting
Ngudi Waluyo hospital
Blitar, East Java
Etty F Ruliatna, dr, etty97@gmail.com
Sofiyana A Sahara, dr, sofianaanissahara@gmail.com
- Recruiting
dr. Saiful Anwar hospital
Malang, East Java, 65111
Dewi Santosaningsih, PhD, +62-341-569117 ext. 111, dewi.santosa@ub.ac.id
Shod A Dzulkarnaen, Master, shodazul@gmail.com
About this study
Official title: The Impact of Hospital Care for COVID-19 on the Prevalence of Multidrug-resistant Microorganisms Among Patients Compared to Non-COVID-19 Hospital Care in Limited-resource Hospitals in Indonesia
The effect of the COVID-19 pandemic on the emergence and spread of antibiotic-resistant bacteria is largely unknown, especially in low-resource settings. We aim to investigate the prevalence and relatedness of multidrug-resistant bacteria among patients in both COVID-19 and non-COVID-19 wards in two hospitals in Indonesia. Bacterial isolates will be collected from clinical sample and by screening of patients at discharge followed by 30 days after discharge. Aspects of hospital care that may be different in COVID-19 wards versus non-COVID-19 wards and that are considered important determinants for antimicrobial resistance (AMR) will be measured: hand hygiene compliance, use of personal protective equipment, and antibiotic use. Comparison of these data from COVID-19 wards to non-COVID-19 wards will increase our understanding of multidrug-resistant bacteria and provide further insight into the effect of interventions for AMR.
The hypothesis of this study are: 1) the prevalence of multidrug-resistant bacteria in COVID-19 wards is higher than non-COVID-19 wards; 2) there is a relatedness of multidrug-resistant bacteria circulating either in the COVID-19 wards or non-COVID-19 wards; 3) the hand-hygiene compliance is lower in the COVID-19 wards than non-COVID-19 wards, however the personal protective equipment use compliance is higher in the COVID-19 wards than non-COVID-19 wards; 4) the antibiotic use in non-COVID-19 wards is better qualitatively; 5) the use of Ciprofloxacin, Gentamicin, and Ceftriaxone in non-COVID-19 wards is higher than in COVID-19 wards.
Read the detailed description
The overall objective of the study is to reveal the impact of hospital care for COVID-19 patients on the prevalence of MDRO among COVID-19 patients, compared to non-COVID-19 hospital care and the prevalence of MDRO among non-COVID-19 patients, with its underlying determinants in limited-resource hospitals in Indonesia.
Specific aims of the study:
- To measure the prevalence of MDRO in the COVID-19 wards compared to non-COVID-19 wards.
- To investigate the transmission of the most prevalent MDRO in the COVID-19 wards compared to non-COVID-19 wards.
- To analyze the hand hygiene compliance and use of PPE in COVID-19 wards compared to non-COVID-19 wards.
- To analyze the antibiotic use in COVID-19 wards compared to non-COVID-19 wards.
Design of the study:
A prospective, observational cohort study will be performed in both COVID-19 wards and non-COVID-19 wards of a secondary care and a tertiary care hospital in the province of East Java in Indonesia. Both intensive care units (ICUs) and non-ICUs will be used. The tertiary care hospital in Malang is the Dr. Saiful Anwar hospital with 882 beds. Currently, 80 COVID-19 patients are admitted each month. The secondary care hospital has 250 beds, and approximately 25 COVID-19 patients are admitted each month.
The specific aims will be addressed as follows:
- MDRO prevalence The following MDROs will be included: MRSA, ESBL-producing Escherichia coli, ESBL-producing and carbapenemase-producing K. pneumoniae, carbapenem-resistant P. aeruginosa, and carbapenem-resistant A. baumannii. These will be searched for and collected via two approaches:
- Detection by routine clinical cultures from patients during their hospital stay, both in the COVID-19 wards and non-COVID-19 wards. Blood, lower respiratory tract specimens, pus, and urine will be eligible for inclusion in the study. Identification and antibiotic susceptibility testing of the MDROs will be performed by the Vitek2 system. Demographic data and data on medical history, in-hospital mortality, length of stay, and antibiotic use will be collected from the medical records, according to the national regulations of medical research. The overall number of clinical cultures and their results will be collected for prevalence calculations (WHOnet).
- As results from clinical cultures only reveal the tip of the MDRO iceberg, adult patients will be actively screened for MDRO carriage on the day of discharge and 30 days post-discharge from the COVID-19 ward and the non-COVID-19 ward, after informed consent. Discharge screening has been used as an approach in previous studies, and shown to be useful to detect MDRO transmission in the hospital. Screening on admission would be useful as well, but is not feasible on the COVID-wards due to workload when a patient is ill and needs immediate care. The 30-day post-discharge screening is a novel approach which may reveal MDROs that are still undetectable (i.e. in lowloads) in or on the patient's body on the moment of discharge, for example due to antibiotic use. All adult patients discharged from these wards are eligible for inclusion in the study. However, patients discharged within 48 hours of admission and patients who either live outside the city of Malang or their address is unclear are excluded. The 30-day post-discharge screening can be organized via the local public health centre. Sample size consideration: We expect to include at least 500 COVID-19 patients and 500 non-COVID-19 patients for MDRO detection from clinical culture, and at least 120 COVID-19 and 120 non-COVID-19 patients for active screening. Microbiological methods: Anterior nares and rectal swabs will be taken from each patient for discharge and post-discharge screening using sterile cotton swabs and transported to the laboratory in Amies transport medium for further processing within 24 hours of sampling. Isolation and identification of MDROs from the swabs will be performed as previously described. Confirmation of ESBL production will be done with the combination disk test, carbapenemase production with the CIM test. Isolates will be stored in duplicate as was done in our previous studies.
- Analysis of MDRO transmission Detection of common resistance genes (i.e. mecA, blaNDM etc.) will be conducted by polymerase chain reaction. The clonality of MDROs will be evaluated for the most prevalent MDROs: by spa/MLVA typing (MRSA) and whole genome sequencing (Gram-negative MDRO; Illumina/nanopore).
- Hand hygiene and PPE The direct observation method will be applied to establish hand hygiene compliance rate and use of PPE (gloves, gowns, masks). This will be done monthly during the one year period that bacterial isolates are collected.
- Antibiotic use analysis Qualitative evaluation of antibiotic use will be performed by the Gyssens' algorithm and subsequent comparison of COVID-19 patients and non-COVID-19 patients either with or without MDRO infection or colonization. Furthermore, the DDD value of ceftriaxone, gentamicin, and ciprofloxacin will be compared.
- Conditions
- Antibiotic Resistant Infection, COVID-19
- Keywords
- Antimicrobial resistant, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 | Not described | |
| non-COVID-19 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidrug resistant bacteria prevalence
MRSA, ESBL-producing Escherichia coli, ESBL-producing and carbapenemase-producing K. pneumoniae, carbapenem-resistant P. aeruginosa, and carbapenem-resistant A. baumannii will be searched for via two approaches including clinical culture and active screening among COVID-19 patients and non -COVID-19 patients.
Measured: One year
Multidrug resistant bacteria transmission
Detection of common resistance genes (i.e. mecA, blaNDM etc.) will be conducted by polymerase chain reaction. The clonality of MDROs will be evaluated for the most prevalent MDROs: by spa/MLVA typing (MRSA) and whole genome sequencing (Gram-negative MDRO; Illumina/nanopore).
Measured: One year
Hand Hygiene and Personal Protective Equipment Use Compliance
The direct observation method will be applied to establish hand hygiene compliance rate and use of PPE (gloves, gowns, masks).
Measured: One year
Antibiotic use analysis
Qualitative evaluation of antibiotic use will be performed by the Gyssens' algorithm and subsequent comparison of COVID-19 patients and non-COVID-19 patients either with or without MDRO infection or colonization. Furthermore, the DDD value of ceftriaxone, gentamicin, and ciprofloxacin will be compared.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start7 Mar 2022
- Primary completion7 Dec 2022 (estimated)
- Study completion7 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistant InfectionStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,110 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- British Society for Antimicrobial Chemotherapy, University of Brawijaya, Saiful Anwar Hospital, Ngudi Waluyo Hospital
- Responsible party
- Principal investigator, Juliëtte Severin, Erasmus Medical Center
- Investigators
- Dewi Santosaningsih, PhD, Principal investigator, Dpt Clin Microbiology, Faculty of Medicine, Brawijaya University/Dr Saiful Anwar Hospital, Malang, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293483
- Sponsor's protocol ID
- 400/213/K.3/302/2021
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- Individual data sharing
- No
Publications
Saharman YR, Karuniawati A, Sedono R, Aditianingsih D, Sudarmono P, Goessens WHF, Klaassen CHW, Verbrugh HA, Severin JA. Endemic carbapenem-nonsusceptible Acinetobacter baumannii-calcoaceticus complex in intensive care units of the national referral hospital in Jakarta, Indonesia. Antimicrob Resist Infect Control. 2018 Jan 12;7:5. doi: 10.1186/s13756-017-0296-7. eCollection 2018.
PubMed 29344351Hsu LY, Apisarnthanarak A, Khan E, Suwantarat N, Ghafur A, Tambyah PA. Carbapenem-Resistant Acinetobacter baumannii and Enterobacteriaceae in South and Southeast Asia. Clin Microbiol Rev. 2017 Jan;30(1):1-22. doi: 10.1128/CMR.masthead.30-1. Epub 2016 Oct 19.
PubMed 27795305Clancy CJ, Nguyen MH. Coronavirus Disease 2019, Superinfections, and Antimicrobial Development: What Can We Expect? Clin Infect Dis. 2020 Dec 17;71(10):2736-2743. doi: 10.1093/cid/ciaa524.
PubMed 32361747Rawson TM, Moore LSP, Zhu N, Ranganathan N, Skolimowska K, Gilchrist M, Satta G, Cooke G, Holmes A. Bacterial and Fungal Coinfection in Individuals With Coronavirus: A Rapid Review To Support COVID-19 Antimicrobial Prescribing. Clin Infect Dis. 2020 Dec 3;71(9):2459-2468. doi: 10.1093/cid/ciaa530.
PubMed 32358954Lestari ES, Severin JA, Filius PM, Kuntaman K, Duerink DO, Hadi U, Wahjono H, Verbrugh HA; Antimicrobial Resistance in Indonesia: Prevalence and Prevention (AMRIN). Antimicrobial resistance among commensal isolates of Escherichia coli and Staphylococcus aureus in the Indonesian population inside and outside hospitals. Eur J Clin Microbiol Infect Dis. 2008 Jan;27(1):45-51. doi: 10.1007/s10096-007-0396-z. Epub 2007 Oct 13.
PubMed 17934766Santosaningsih D, Santoso S, Budayanti NS, Kuntaman K, Lestari ES, Farida H, Hapsari R, Hadi P, Winarto W, Milheirico C, Maquelin K, Willemse-Erix D, van Belkum A, Severin JA, Verbrugh HA. Epidemiology of Staphylococcus aureus harboring the mecA or Panton-Valentine leukocidin genes in hospitals in Java and Bali, Indonesia. Am J Trop Med Hyg. 2014 Apr;90(4):728-34. doi: 10.4269/ajtmh.13-0734. Epub 2014 Feb 24.
PubMed 24567320Saharman YR, Pelegrin AC, Karuniawati A, Sedono R, Aditianingsih D, Goessens WHF, Klaassen CHW, van Belkum A, Mirande C, Verbrugh HA, Severin JA. Epidemiology and characterisation of carbapenem-non-susceptible Pseudomonas aeruginosa in a large intensive care unit in Jakarta, Indonesia. Int J Antimicrob Agents. 2019 Nov;54(5):655-660. doi: 10.1016/j.ijantimicag.2019.08.003. Epub 2019 Aug 7.
PubMed 31398483Saharman YR, Karuniawati A, Sedono R, Aditianingsih D, Goessens WHF, Klaassen CHW, Verbrugh HA, Severin JA. Clinical impact of endemic NDM-producing Klebsiella pneumoniae in intensive care units of the national referral hospital in Jakarta, Indonesia. Antimicrob Resist Infect Control. 2020 May 11;9(1):61. doi: 10.1186/s13756-020-00716-7.
PubMed 32393386van der Zwaluw K, de Haan A, Pluister GN, Bootsma HJ, de Neeling AJ, Schouls LM. The carbapenem inactivation method (CIM), a simple and low-cost alternative for the Carba NP test to assess phenotypic carbapenemase activity in gram-negative rods. PLoS One. 2015 Mar 23;10(3):e0123690. doi: 10.1371/journal.pone.0123690. eCollection 2015.
PubMed 25798828Santosaningsih D, Erikawati D, Santoso S, Noorhamdani N, Ratridewi I, Candradikusuma D, Chozin IN, Huwae TECJ, van der Donk G, van Boven E, Voor In 't Holt AF, Verbrugh HA, Severin JA. Intervening with healthcare workers' hand hygiene compliance, knowledge, and perception in a limited-resource hospital in Indonesia: a randomized controlled trial study. Antimicrob Resist Infect Control. 2017 Feb 16;6:23. doi: 10.1186/s13756-017-0179-y. eCollection 2017.
PubMed 28239452
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hospital Care for COVID-19 on the Prevalence of Multidrug-resistant Microorganisms Among Patients Compared to Non-COVID-19 Hospital Care in Limited-resource Hospitals in Indonesia
- ClinicalTrials.gov ID
- NCT05293483
- Acronym / sponsor ID
- 400/213/K.3/302/2021
- Conditions
- Antibiotic Resistant Infection, COVID-19
- Keywords
- Antimicrobial resistant, COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,110 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- British Society for Antimicrobial Chemotherapy, University of Brawijaya, Saiful Anwar Hospital, Ngudi Waluyo Hospital
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Dec 2022 (estimated)
- Study completion
- 7 Mar 2023 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of the COVID-19 pandemic on the emergence and spread of antibiotic-resistant bacteria is largely unknown, especially in low-resource settings. We aim to investigate the prevalence and relatedness of multidrug-resistant bacteria among patients in both COVID-19 and non-COVID-19 wards in two hospitals in Indonesia. Bacterial isolates will be collected from clinical sample and by screening of patients at discharge followed by 30 days after discharge. Aspects of hospital care that may be different in COVID-19 wards versus non-COVID-19 wards and that are considered important determinants for antimicrobial resistance (AMR) will be measured: hand hygiene compliance, use of personal protective equipment, and antibiotic use. Comparison of these data from COVID-19 wards to non-COVID-19 wards will increase our understanding of multidrug-resistant bacteria and provide further insight into the effect of interventions for AMR.
The hypothesis of this study are: 1) the prevalence of multidrug-resistant bacteria in COVID-19 wards is higher than non-COVID-19 wards; 2) there is a relatedness of multidrug-resistant bacteria circulating either in the COVID-19 wards or non-COVID-19 wards; 3) the hand-hygiene compliance is lower in the COVID-19 wards than non-COVID-19 wards, however the personal protective equipment use compliance is higher in the COVID-19 wards than non-COVID-19 wards; 4) the antibiotic use in non-COVID-19 wards is better qualitatively; 5) the use of Ciprofloxacin, Gentamicin, and Ceftriaxone in non-COVID-19 wards is higher than in COVID-19 wards.
Detailed description
The overall objective of the study is to reveal the impact of hospital care for COVID-19 patients on the prevalence of MDRO among COVID-19 patients, compared to non-COVID-19 hospital care and the prevalence of MDRO among non-COVID-19 patients, with its underlying determinants in limited-resource hospitals in Indonesia.
Specific aims of the study:
- To measure the prevalence of MDRO in the COVID-19 wards compared to non-COVID-19 wards.
- To investigate the transmission of the most prevalent MDRO in the COVID-19 wards compared to non-COVID-19 wards.
- To analyze the hand hygiene compliance and use of PPE in COVID-19 wards compared to non-COVID-19 wards.
- To analyze the antibiotic use in COVID-19 wards compared to non-COVID-19 wards.
Design of the study:
A prospective, observational cohort study will be performed in both COVID-19 wards and non-COVID-19 wards of a secondary care and a tertiary care hospital in the province of East Java in Indonesia. Both intensive care units (ICUs) and non-ICUs will be used. The tertiary care hospital in Malang is the Dr. Saiful Anwar hospital with 882 beds. Currently, 80 COVID-19 patients are admitted each month. The secondary care hospital has 250 beds, and approximately 25 COVID-19 patients are admitted each month.
The specific aims will be addressed as follows:
- MDRO prevalence The following MDROs will be included: MRSA, ESBL-producing Escherichia coli, ESBL-producing and carbapenemase-producing K. pneumoniae, carbapenem-resistant P. aeruginosa, and carbapenem-resistant A. baumannii. These will be searched for and collected via two approaches:
- Detection by routine clinical cultures from patients during their hospital stay, both in the COVID-19 wards and non-COVID-19 wards. Blood, lower respiratory tract specimens, pus, and urine will be eligible for inclusion in the study. Identification and antibiotic susceptibility testing of the MDROs will be performed by the Vitek2 system. Demographic data and data on medical history, in-hospital mortality, length of stay, and antibiotic use will be collected from the medical records, according to the national regulations of medical research. The overall number of clinical cultures and their results will be collected for prevalence calculations (WHOnet).
- As results from clinical cultures only reveal the tip of the MDRO iceberg, adult patients will be actively screened for MDRO carriage on the day of discharge and 30 days post-discharge from the COVID-19 ward and the non-COVID-19 ward, after informed consent. Discharge screening has been used as an approach in previous studies, and shown to be useful to detect MDRO transmission in the hospital. Screening on admission would be useful as well, but is not feasible on the COVID-wards due to workload when a patient is ill and needs immediate care. The 30-day post-discharge screening is a novel approach which may reveal MDROs that are still undetectable (i.e. in lowloads) in or on the patient's body on the moment of discharge, for example due to antibiotic use. All adult patients discharged from these wards are eligible for inclusion in the study. However, patients discharged within 48 hours of admission and patients who either live outside the city of Malang or their address is unclear are excluded. The 30-day post-discharge screening can be organized via the local public health centre. Sample size consideration: We expect to include at least 500 COVID-19 patients and 500 non-COVID-19 patients for MDRO detection from clinical culture, and at least 120 COVID-19 and 120 non-COVID-19 patients for active screening. Microbiological methods: Anterior nares and rectal swabs will be taken from each patient for discharge and post-discharge screening using sterile cotton swabs and transported to the laboratory in Amies transport medium for further processing within 24 hours of sampling. Isolation and identification of MDROs from the swabs will be performed as previously described. Confirmation of ESBL production will be done with the combination disk test, carbapenemase production with the CIM test. Isolates will be stored in duplicate as was done in our previous studies.
- Analysis of MDRO transmission Detection of common resistance genes (i.e. mecA, blaNDM etc.) will be conducted by polymerase chain reaction. The clonality of MDROs will be evaluated for the most prevalent MDROs: by spa/MLVA typing (MRSA) and whole genome sequencing (Gram-negative MDRO; Illumina/nanopore).
- Hand hygiene and PPE The direct observation method will be applied to establish hand hygiene compliance rate and use of PPE (gloves, gowns, masks). This will be done monthly during the one year period that bacterial isolates are collected.
- Antibiotic use analysis Qualitative evaluation of antibiotic use will be performed by the Gyssens' algorithm and subsequent comparison of COVID-19 patients and non-COVID-19 patients either with or without MDRO infection or colonization. Furthermore, the DDD value of ceftriaxone, gentamicin, and ciprofloxacin will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 | – | – |
| non-COVID-19 | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients will be actively screened for MDRO carriage on the day of discharge and 30 days post-discharge from the COVID-19 ward and the non-COVID-19 ward (ICU and internal medicine wards)
Key inclusion criteria (1 listed)
- All adult patients discharged from Covid wards and non Covid wards (ICU and internal medicine wards)
Key exclusion criteria (2 listed)
- Patients discharged within 48 hours of admission
- Patients who either live outside the city of Malang or their address is unclear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multidrug resistant bacteria prevalence
Time frame: One year
MRSA, ESBL-producing Escherichia coli, ESBL-producing and carbapenemase-producing K. pneumoniae, carbapenem-resistant P. aeruginosa, and carbapenem-resistant A. baumannii will be searched for via two approaches including clinical culture and active screening among COVID-19 patients and non -COVID-19 patients.
Multidrug resistant bacteria transmission
Time frame: One year
Detection of common resistance genes (i.e. mecA, blaNDM etc.) will be conducted by polymerase chain reaction. The clonality of MDROs will be evaluated for the most prevalent MDROs: by spa/MLVA typing (MRSA) and whole genome sequencing (Gram-negative MDRO; Illumina/nanopore).
Hand Hygiene and Personal Protective Equipment Use Compliance
Time frame: One year
The direct observation method will be applied to establish hand hygiene compliance rate and use of PPE (gloves, gowns, masks).
Antibiotic use analysis
Time frame: One year
Qualitative evaluation of antibiotic use will be performed by the Gyssens' algorithm and subsequent comparison of COVID-19 patients and non-COVID-19 patients either with or without MDRO infection or colonization. Furthermore, the DDD value of ceftriaxone, gentamicin, and ciprofloxacin will be compared.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Background: PubMed 29344351Saharman YR, Karuniawati A, Sedono R, Aditianingsih D, Sudarmono P, Goessens WHF, Klaassen CHW, Verbrugh HA, Severin JA. Endemic carbapenem-nonsusceptible Acinetobacter baumannii-calcoaceticus complex in intensive care units of the national referral hospital in Jakarta, Indonesia. Antimicrob Resist Infect Control. 2018 Jan 12;7:5. doi: 10.1186/s13756-017-0296-7. eCollection 2018.
- Background: PubMed 27795305Hsu LY, Apisarnthanarak A, Khan E, Suwantarat N, Ghafur A, Tambyah PA. Carbapenem-Resistant Acinetobacter baumannii and Enterobacteriaceae in South and Southeast Asia. Clin Microbiol Rev. 2017 Jan;30(1):1-22. doi: 10.1128/CMR.masthead.30-1. Epub 2016 Oct 19.
- Background: PubMed 32361747Clancy CJ, Nguyen MH. Coronavirus Disease 2019, Superinfections, and Antimicrobial Development: What Can We Expect? Clin Infect Dis. 2020 Dec 17;71(10):2736-2743. doi: 10.1093/cid/ciaa524.
- Background: PubMed 32358954Rawson TM, Moore LSP, Zhu N, Ranganathan N, Skolimowska K, Gilchrist M, Satta G, Cooke G, Holmes A. Bacterial and Fungal Coinfection in Individuals With Coronavirus: A Rapid Review To Support COVID-19 Antimicrobial Prescribing. Clin Infect Dis. 2020 Dec 3;71(9):2459-2468. doi: 10.1093/cid/ciaa530.
- Background: PubMed 17934766Lestari ES, Severin JA, Filius PM, Kuntaman K, Duerink DO, Hadi U, Wahjono H, Verbrugh HA; Antimicrobial Resistance in Indonesia: Prevalence and Prevention (AMRIN). Antimicrobial resistance among commensal isolates of Escherichia coli and Staphylococcus aureus in the Indonesian population inside and outside hospitals. Eur J Clin Microbiol Infect Dis. 2008 Jan;27(1):45-51. doi: 10.1007/s10096-007-0396-z. Epub 2007 Oct 13.
- Background: PubMed 24567320Santosaningsih D, Santoso S, Budayanti NS, Kuntaman K, Lestari ES, Farida H, Hapsari R, Hadi P, Winarto W, Milheirico C, Maquelin K, Willemse-Erix D, van Belkum A, Severin JA, Verbrugh HA. Epidemiology of Staphylococcus aureus harboring the mecA or Panton-Valentine leukocidin genes in hospitals in Java and Bali, Indonesia. Am J Trop Med Hyg. 2014 Apr;90(4):728-34. doi: 10.4269/ajtmh.13-0734. Epub 2014 Feb 24.
- Background: PubMed 31398483Saharman YR, Pelegrin AC, Karuniawati A, Sedono R, Aditianingsih D, Goessens WHF, Klaassen CHW, van Belkum A, Mirande C, Verbrugh HA, Severin JA. Epidemiology and characterisation of carbapenem-non-susceptible Pseudomonas aeruginosa in a large intensive care unit in Jakarta, Indonesia. Int J Antimicrob Agents. 2019 Nov;54(5):655-660. doi: 10.1016/j.ijantimicag.2019.08.003. Epub 2019 Aug 7.
- Background: PubMed 32393386Saharman YR, Karuniawati A, Sedono R, Aditianingsih D, Goessens WHF, Klaassen CHW, Verbrugh HA, Severin JA. Clinical impact of endemic NDM-producing Klebsiella pneumoniae in intensive care units of the national referral hospital in Jakarta, Indonesia. Antimicrob Resist Infect Control. 2020 May 11;9(1):61. doi: 10.1186/s13756-020-00716-7.
- Background: PubMed 25798828van der Zwaluw K, de Haan A, Pluister GN, Bootsma HJ, de Neeling AJ, Schouls LM. The carbapenem inactivation method (CIM), a simple and low-cost alternative for the Carba NP test to assess phenotypic carbapenemase activity in gram-negative rods. PLoS One. 2015 Mar 23;10(3):e0123690. doi: 10.1371/journal.pone.0123690. eCollection 2015.
- Background: PubMed 28239452Santosaningsih D, Erikawati D, Santoso S, Noorhamdani N, Ratridewi I, Candradikusuma D, Chozin IN, Huwae TECJ, van der Donk G, van Boven E, Voor In 't Holt AF, Verbrugh HA, Severin JA. Intervening with healthcare workers' hand hygiene compliance, knowledge, and perception in a limited-resource hospital in Indonesia: a randomized controlled trial study. Antimicrob Resist Infect Control. 2017 Feb 16;6:23. doi: 10.1186/s13756-017-0179-y. eCollection 2017.
- Individual participant dataSharing planned: No
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INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dewi Santosaningsih, PhD principal investigator
Dpt Clin Microbiology, Faculty of Medicine, Brawijaya University/Dr Saiful Anwar Hospital, Malang, Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Resistant Infection and COVID-19, run by Erasmus Medical Center at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dewi Santosaningsih, PhD (+62-341-569117 ext. 111, dewi.santosa@ub.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multidrug resistant bacteria prevalence (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293483, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.