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.: PACTR201909715467725 Date of Approval: 20/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Procalcitonin-guided antibiotic therapy for suspected and confirmed sepsis of patients in a surgical-trauma ICU: a prospective, two-period cross-over, interventional study
Official scientific title Procalcitonin-guided antibiotic therapy for suspected and confirmed sepsis of patients in a surgical-trauma ICU: a prospective, two-period cross-over, interventional study
Brief summary describing the background and objectives of the trial Studies on procalcitonin guided antibiotic therapy are mainly from Europe. There are few studies from developing countries on the use of a PCT algorithm for antibiotic stewardship. Most ICU studies contain relatively few numbers of surgical patients. It was useful to have a study that analyses the use of established PCT algorithms in surgical trauma patients in South Africa. The study was carried out to determine if a procalcitonin-guided clinical algorithm would reduce total antibiotic days compared to standard antibiotic treatment in an ICU setting. The study was done in surgical trauma patients with suspected or proven sepsis.
Type of trial CCT
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 Bacterial infections
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2014
Actual trial start date 22/04/2014
Anticipated date of last follow up 30/04/2015
Actual Last follow-up date 14/08/2015
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group not applicable not applicable The initial phase was a period of gathering baseline data on antibiotic prescribing habits in the ICU. Forty patients with suspected or confirmed sepsis were recruited consecutively into the control group between April 2014 and January 2015. All the data described in section 3.2 was collected during this period.Procalcitonin was not routinely measured in patients with suspected or confirmed sepsis and there was no algorithm in place to guide antibiotic treatment based on the PCT.Antibiotics were given according to the existing standard of care and to cover the expected spectrum of micro-organisms. Antibiotics were changed to cover the spectrum of organisms cultured from the site of sepsis. Decisions regarding duration of antibiotic treatment were left at the discretion of the attending doctor. 40 Active-Treatment of Control Group
Experimental Group Procalcitonin group Not applicable Not applicable In the intervention period, 40 patients with confirmed or suspected sepsis were recruited consecutively into the intervention group between February 2015 and July 2015. The PCT level was measured at study recruitment and then on alternate days. Antibiotics were given empirically according to the site-specific ICU algorithm and always covering at least the spectrum of previously prescribed antimicrobials as well as expected organisms. Antibiotics were escalated or de-escalated according to proven culture results. If the PCT decreased by ≥80% from the peak PCT level, or an absolute value of less than 0.5 µg/L clinicians were encouraged to stop antibiotics. Antibiotics were not stopped if there were ongoing signs of sepsis (e.g. temperature ≥ 38.3ºC) with an obvious source of sepsis. The PCT complemented but did not replace clinical decision making and clinicians were able to deviate from the PCT algorithm if the need arose. Although clinicians were encouraged to stop antibiotics according to this PCT algorithm the decision to stop was at the discretion of the attending clinician. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients over the age of 18 years admitted to the trauma ICU with suspected or confirmed bacterial sepsis with written consent and who survived more than 48 hours after study inclusion. Patients in whom consent could not be obtained Patients with severe co-morbidities e.g. congestive cardiac failure, cirrhosis, insulin dependent diabetes, chronic renal failure requiring dialysis, pregnancy and advanced HIV infection with CD4 ˂100 cells/µL. Patients requiring prolonged antibiotic therapy e.g. Clostridium difficile, Listeria monocytogenes, tuberculosis, fungal sepsis, osteomyelitis, lung abscess and sepsis involving a prosthetic device that could not be removed Patients who had received antibiotics for more than 48 hours before enrollment Patients with poor chance of survival (ISS score ≥45, injury critical or untreatable at screening). 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) 18 Year(s) 100 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 12/09/2013 Human Research Ethics Committee of the university of Witwatersrand
Ethics Committee Address
Street address City Postal code Country
Research Office, Faculty of Health Sciences, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Duration of antibiotic treatment for every sepsis episode until 28 days after study inclusion. 2) Clinical outcomes: a. Antibiotic free days alive at 28 days from study inclusion. b. 28 day hospital mortality (death from any cause). c. ICU length of stay. d. Recurrence or relapse of infection 28 days after study inclusion or at death event/discharge from hospital
Secondary Outcome 1) Sources of sepsis as per positive microbiology cultures from clinical specimens with clinical correlation. 2) Bacterial species isolated from clinical specimens and susceptibility profiles. 3) Emergence of multidrug resistant bacteria in the two groups. 4) Profile of procalcitonin concentrations in septic trauma patients. 5) Compliance with procalcitonin study algorithm 6) Clinical outcomes of patients in who study algorithm was over-ruled. 28 days after study inclusion or at death event/discharge from hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Charlotte Maxeke Johannesburg academic hospital Jubilee road Johannesburg 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Rispah Chomba 13 Scott avenue, Edenvale South Africa 1609 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rispah Chomba 13 Scott avenue, Edenvale Johannesburg 1609 South Africa Individual
Secondary Sponsor Trauma intensive care unit Charlotte Maxeke academic hospital Jubilee road Parktown Johannesburg 2196 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Maeyane Steve Moeng Trauma ICU, Area 376, Charlotte Maxeke Johannesburg hospital, 17 Jubilee Road, Parktown Johannesburg 2000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rispah Chomba irungurispah@yahoo.com 27725329502 13 Scott avenue, Edenvale
City Postal code Country Position/Affiliation
Johannesburg 1609 South Africa Pathologist
Role Name Email Phone Street address
Public Enquiries Steve Moeng drmoeng.trauma@gmail.com +27828878621 Trauma ICU, area 376, Charlotte Maxeke academic hospital, Jubilee Rd, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Trauma surgeon
Role Name Email Phone Street address
Scientific Enquiries Warren Lowman Warren.Lowman@wits.ac.za +27829220834 Faculty of health sciences, Department of clinical microbiology, University of Witwatersrand,Jubilee Rd, Parktown,
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Raw data in an Excel spreadsheet Study Protocol Available after study publication from 2020 Controlled access to qualified persons. Decisions to be made by study investigators
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