Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509707655659 Date of Registration: 10/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pathogen colonisation status and antimicrobial prescription in critically ill adults
Official scientific title Pathogen colonisation status and antimicrobial prescription in critically ill adults
Brief summary describing the background and objectives of the trial Increased broad-spectrum antimicrobial use is a recognised driver of antimicrobial resistance. The fragility of the clinical status in critically ill patients often necessitates prescription of broad-spectrum antimicrobial agents if bacterial sepsis cannot be conclusively excluded. The ensuing selective pressure changes the bacterial ecology of the unit. The burden of underlying comorbidities in critically ill adults is high, and the use of supportive or life-saving interventions is routine, resulting in a population that is at higher risk for hospital acquired infection compared to other population groups. A central tenet in the pathogenesis of infection is that colonisation precedes invasive infection. Strategies such as identification of colonisation may provide decision support to clinicians to withhold broad-spectrum antimicrobial use in non-colonised patients to disrupt this cycle. Research question: Can identification of critically ill adults colonised with selected pathogens of concern guide antimicrobial therapy and infection control interventions? Core objectives: - To compare the performance of active surveillance cultures with standard of care, represented by clinically guided cultures, in detecting colonisation with pathogens of concern among critically ill adults. - To model the transmission dynamics of pathogens of concern within the intensive care unit (including prevalence of colonisation on admission, change in colonisation status during admission, molecular relatedness and development of hospital acquired infection) - To measure the effect of knowledge of colonisation status with multidrug resistant Gram negative bacilli on broad-spectrum antimicrobial use. Pathogen of concern in this study: extended spectrum beta-lactamase producing Enterobacterales, carbapenem resistant Enterobacterales, carbapenem resistant Acinetobacter baumannii)
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Multidrug resistant Gram negative bacilli, infection prevention and control, antimicrobial use
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/09/2025
Actual trial start date
Anticipated date of last follow up 01/11/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 894
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Active serial surveillance cultures for multidrug resistant Gram negative bacilli in adult ICUs Before: Observational component (6 months). No intervention. After: Collection of active surveillance cultures from 4 specific body sites every 72-96 hours of ICU admission (6 months) 6 months for each arm, total 12 months Participants admitted into the ICUs will have data collected (as in the observational arm) as well as the collection of superficial swabs from 4 different body sites (or a tracheal aspirate sample if the participant is intubated). These swabs will be processed and the presence of specific multidrug resistant Gram negatives will be noted (ESBL-producing Enterobacterales, carbapenem-resistant Enterobacterales, carbapenem-resistant Acinetobacter baumannii). Results will be reported on the laboratory information system. Should these organisms be present, healthcare workers in the unit will be made aware and clinicians may use these results to guide antimicrobial prescription in the setting of a clinical deterioration. We will assess at unit level whether antimicrobial use for specific broad-spectrum agents (carbapenems, colistin) will be impacted, and whether the hospital-acquired infection rate changes in comparison with the observational component. 894
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All participants above the age of 13 years admitted to the medical or surgical ICUs at Tygerberg Hospital Participants with: - bleeding disorders - severe coagulopathy - substantial local pathology (e.g. Fournier’s gangrene) and/or other conditions as judged by the attending clinician in whom collection of active surveillance culture samples will pose significant risk 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 120 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/02/2025 SU HREC 2
Ethics Committee Address
Street address City Postal code Country
Stellenbosch University Faculty of Medicine and Health Sciences, Tygerberg Campus, Francie Van Zyl Avenue, Parow, Cape Town Cape Town 7500 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Aggregated antimicrobial use in the ICUs, specifically the carbapenems and colistin End of trial
Secondary Outcome 30-day all cause and in-hospital mortality End of trial
Primary Outcome Hospital acquired infection rate in the ICUs End of trial
Secondary Outcome Attributable mortality in participants colonised with pathogens of concern End of trial
Secondary Outcome Performance of active surveillance cultures compared with standard of care in detecting colonisation with pathogens of concern End of trial
Secondary Outcome Transmission dynamics of pathogens of concern within the ICUs End of trial
Secondary Outcome Strain relatedness of pathogens of concern within the ICUs End of trial
Secondary Outcome Cost effectiveness of serial active surveillance cultures compared with standard of care End of trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tygerberg Hospital Francie Van Zyl Avenue, Parow Cape Town 7500 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University Staff Doctoral Programme 123 Francis Baard Street Pretoria 0002 South Africa
South African Medical Research Council 1 Soutpansberg Road Pretoria 0001 South Africa
SU FMHS Early Career Research Fund Ryneveld Street Stellenbosch 7602 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Not applicable - NA - South Africa NA
COLLABORATORS
Name Street address City Postal code Country
Prof MJM Bonten Provinciehuis, Archimedeslaan 6 Utrecht 3584 Netherlands
Prof CFN Koegelenberg Tygerberg Hospital, Francie Van Zyl Avenue, Parow Cape Town 7500 South Africa
Prof JJ Taljaard Tygerberg Hospital, Francie Van Zyl Avenue, Parow Cape Town 7500 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kessendri Reddy kreddy@sun.ac.za +27219384021 Tygerberg Hospital, Francie Van Zyl Avenue, Parow
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Pathologist and Senior lecturer
Role Name Email Phone Street address
Public Enquiries Kessendri Reddy kreddy@sun.ac.za +27219384021 Tygerberg Hospital, Francie Van Zyl Avenue, Parow
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Pathologist and Senior lecturer
Role Name Email Phone Street address
Scientific Enquiries Kessendri Reddy kreddy@sun.ac.za +27219384021 Tygerberg Hospital, Francie Van Zyl Avenue, Parow
City Postal code Country Position/Affiliation
Cape Town 7500 South Africa Pathologist and Senior lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, appendices) Study Protocol Immediately following publication, ending 5 years following article publication Controlled access, for individual participant data meta-analysis and/or reasonable specific aims in an approved proposal, with investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose. Proposals should be directed to kreddy@sun.ac.za and will be evaluated by the PI and supervisor team. To gain access, data requestors will need to sign a data access/data sharing agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 02/09/2025 Trial consists of two arms (before and after), each of which will recruit 447 participants. Total anticipated participants = 894. 447 894
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/08/2025 Could not capture details on before and after arm separately, so revised the entry to include both Experimental Group, After, Collection of active surveillance cultures from 4 specific body sites every 72-96 hours of ICU admission, 6 months, Participants admitted into the ICUs will have data collected (as in the observational arm) as well as the collection of superficial swabs from 4 different body sites (or a tracheal aspirate sample if the participant is intubated). These swabs will be processed and the presence of specific multidrug resistant Gram negatives will be noted (ESBL-producing Enterobacterales, carbapenem-resistant Enterobacterales, carbapenem-resistant Acinetobacter baumannii). Results will be reported on the laboratory information system. Should these organisms be present, healthcare workers in the unit will be made aware and clinicians may use these results to guide antimicrobial prescription in the setting of a clinical deterioration. We will assess at unit level whether antimicrobial use for specific broad-spectrum agents (carbapenems, colistin) will be impacted, and whether the hospital-acquired infection rate changes in comparison with the observational component., 447, Experimental Group, Before and After trial, Before: Observational component (6 months). No intervention. After: Collection of active surveillance cultures from 4 specific body sites every 72-96 hours of ICU admission (6 months), 6 months for each arm, total 12 months, Participants admitted into the ICUs will have data collected (as in the observational arm) as well as the collection of superficial swabs from 4 different body sites (or a tracheal aspirate sample if the participant is intubated). These swabs will be processed and the presence of specific multidrug resistant Gram negatives will be noted (ESBL-producing Enterobacterales, carbapenem-resistant Enterobacterales, carbapenem-resistant Acinetobacter baumannii). Results will be reported on the laboratory information system. Should these organisms be present, healthcare workers in the unit will be made aware and clinicians may use these results to guide antimicrobial prescription in the setting of a clinical deterioration. We will assess at unit level whether antimicrobial use for specific broad-spectrum agents (carbapenems, colistin) will be impacted, and whether the hospital-acquired infection rate changes in comparison with the observational component., 894,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/09/2025 Could not capture details on before and after arm separately, so revised the entry to include both Experimental Group, Before and After trial, Before: Observational component (6 months). No intervention. After: Collection of active surveillance cultures from 4 specific body sites every 72-96 hours of ICU admission (6 months), 6 months for each arm, total 12 months, Participants admitted into the ICUs will have data collected (as in the observational arm) as well as the collection of superficial swabs from 4 different body sites (or a tracheal aspirate sample if the participant is intubated). These swabs will be processed and the presence of specific multidrug resistant Gram negatives will be noted (ESBL-producing Enterobacterales, carbapenem-resistant Enterobacterales, carbapenem-resistant Acinetobacter baumannii). Results will be reported on the laboratory information system. Should these organisms be present, healthcare workers in the unit will be made aware and clinicians may use these results to guide antimicrobial prescription in the setting of a clinical deterioration. We will assess at unit level whether antimicrobial use for specific broad-spectrum agents (carbapenems, colistin) will be impacted, and whether the hospital-acquired infection rate changes in comparison with the observational component., 894, Experimental Group, Active serial surveillance cultures for multidrug resistant Gram negative bacilli in adult ICUs, Before: Observational component (6 months). No intervention. After: Collection of active surveillance cultures from 4 specific body sites every 72-96 hours of ICU admission (6 months), 6 months for each arm, total 12 months, Participants admitted into the ICUs will have data collected (as in the observational arm) as well as the collection of superficial swabs from 4 different body sites (or a tracheal aspirate sample if the participant is intubated). These swabs will be processed and the presence of specific multidrug resistant Gram negatives will be noted (ESBL-producing Enterobacterales, carbapenem-resistant Enterobacterales, carbapenem-resistant Acinetobacter baumannii). Results will be reported on the laboratory information system. Should these organisms be present, healthcare workers in the unit will be made aware and clinicians may use these results to guide antimicrobial prescription in the setting of a clinical deterioration. We will assess at unit level whether antimicrobial use for specific broad-spectrum agents (carbapenems, colistin) will be impacted, and whether the hospital-acquired infection rate changes in comparison with the observational component., 894,