The Impact of Covid-19 Hospital Care on the Prevalence of MDRO in Indonesia

NCT05293483 | Unknown

• 1 other identifier: 400/213/K.3/302/2021
• Study Type: observational
• Target: 1,110
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Antibiotic Resistant Infection; COVID-19

Keywords

Antimicrobial resistant; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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).

  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.

  One year

Study Arms (2)

COVID-19

non-COVID-19

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• All adult patients discharged from Covid wards and non Covid wards (ICU and internal medicine wards)

You may not qualify if:

• Patients discharged within 48 hours of admission
• Patients who either live outside the city of Malang or their address is unclear

Sponsors & Collaborators

• Erasmus Medical Center: lead
• British Society for Antimicrobial Chemotherapy: collaborator
• University of Brawijaya: collaborator
• Saiful Anwar Hospital: collaborator
• Ngudi Waluyo Hospital: collaborator

Study Sites (2)

Ngudi Waluyo hospital

Blitar, East Java, Indonesia

NOT YET RECRUITING

dr. Saiful Anwar hospital

Malang, East Java, 65111, Indonesia

RECRUITING

Related Publications (10)

• 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.

  PMID: 29344351 BACKGROUND

• Hsu 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.

  PMID: 27795305 BACKGROUND

• Clancy 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.

  PMID: 32361747 BACKGROUND

• Rawson 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.

  PMID: 32358954 BACKGROUND

• Lestari 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.

  PMID: 17934766 BACKGROUND

• Santosaningsih 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.

  PMID: 24567320 BACKGROUND

• Saharman 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.

  PMID: 31398483 BACKGROUND

• Saharman 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.

  PMID: 32393386 BACKGROUND

• van 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.

  PMID: 25798828 BACKGROUND

• Santosaningsih 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.

  PMID: 28239452 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The bacterial DNA will be extracted from multidrug resistant bacteria isolates obtained from sputum, blood, pus, and urine of patients hospitalized in both COVID-19 wards and non-COVID-19 wards.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dewi Santosaningsih, PhD

  Dpt Clin Microbiology, Faculty of Medicine, Brawijaya University/Dr Saiful Anwar Hospital, Malang, Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dewi Santosaningsih, PhD

CONTACT

+62-341-569117; dewi.santosa@ub.ac.id

Juliëtte A Severin, PhD MD

CONTACT

+31107033510; j.severin@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Medical coordinator Unit infection prevention

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 24, 2022
• Study Start: March 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: March 7, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)