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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607729609431 Date of Registration: 23/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ComBac-Africa
Official scientific title Combating Multidrug-Resistant Gram-Negative Bacteria in Africa through Diagnostic and Antimicrobial Stewardship: A multicentre, prospective quasi-experimental two-stage study
Brief summary describing the background and objectives of the trial Antimicrobial resistance (AMR) is a major threat to public health and the well-being of humans, with high mortality rates of infections caused by MDR GNB. Sub-Saharan Africa (SSA) suffers from a high burden of AMR, but access to adequate microbiological diagnostics for pathogen identification and resistance testing as well as novel antibiotics that are effective against MDR GNB are scarce. Studies from high-income countries show improved survival of patients with such infections, if novel antibiotics against these pathogens are employed in a targeted manner. However, data from low- and middle-income countries (LMICs) is limited. The purpose of this study is to obtain an accurate picture of the epidemiology of MDR GNB bloodstream infections (BSIs) in hospitals in Côte d’Ivoire, Guinea-Bissau and Nigeria, followed by the development and implementation of an evidence-based AMS algorithm, which is coupled to access to antibiotics (i.e. meropenem, ceftazidime-avibactam, cefiderocol and ceftazidime-avibactam + aztreonam) with proven activity against MDR GNB. Taken together, the overall goal is to improve the management of severe infections due to MDR GNB in SSA.
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 Multi-Drug Resistant Gram-Negative bacterial bloodstream infection
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/08/2026
Actual trial start date
Anticipated date of last follow up 30/11/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 1320
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
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment 28 days Providing evidence-based treatment algorithms that enable targeted access to previously unavailable antibiotics (i.e. meropenem, ceftazidime-avibactam, cefiderocol, and ceftazidime-avibactam + aztreonam). In this study stage, a diagnosis-treatment algorithm that will have been developed based on data collected during study stage 1, will be employed as the intervention to guide the choice of antibiotics active against MDR GNB BSIs. Coupled to the algorithm, a set of specific antibiotics will be made available in the different study settings for treatment of patients with bloodstream infections due to MDR GNB, for which no equally effective antibiotics are routinely available in the study countries. Previously held discussions with the regulatory agencies in the study countries will feed into the development of the algorithm. The novel treatment options include antibiotics which retain activity in MDR GNB with specific resistance profiles such as ESBL-producing isolates and those with carbapenem resistance. If an antibiotic is not yet licensed in the study country, its use will follow the European Medicines Agency’s (EMA) licensing recommendations. The novel stage 2 antibiotics will be sourced centrally and will be handled as investigational products in participating countries where they are not locally registered. The following drugs will be used whenever the causative GNB are tested susceptible and when the standard antibiotics are tested as resistant: Meropenem: to be used against ceftriaxone-resistant isolates and/or those with an ESBL or AmpC phenotype (only in individuals aged 3 months and older; off-label use in severely ill, younger children may be applicable in accordance with international guideline recommendations) Ceftazidime/avibactam: to be used against OXA-48 and/or KPC carbapenemase-producing isolates (without age restriction) Cefiderocol: to be used against GNB with resistance against carbapenems and ceftazidime/avibactam (only in individuals a 660
Control Group Diagnostic 28 days In the observational study stage, the locally used antibiotics according to the currently practiced standard of care for the treatment of BSIs due to MDR GNB will be employed and no intervention pertaining to the choice of antibiotics will be carried out. These will include antibiotics such as ceftriaxone, ampicillin-sulbactam, ampicillin + gentamicin or piperacillin/tazobactam that have been used for many years in the different settings, but do not show activity against specific resistance mechanisms such as extended-spectrum beta-lactamases (ESBLs) or carbapenemases. 660 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with detection of a presumably MDR GNB (identified by growth on MDR screening agars or phenotypic resistance to ceftriaxone or meropenem) in ≥1 blood culture bottle Provision of written informed consent to participate in the study by patient or her/his parents/legal (or legally acceptable) representative(s). In severely ill patients, an emergency consenting procedure will be implemented as an alternative for regular consenting. In addition to the legal guardian’s written consent, oral or written assent will be sought from children aged 6-11 years and 12-17 years, respectively. Age-appropriate assent forms will be used. For neonates and critically ill infants, enrolment will be subject to additional review by the site principal investigator to ensure minimal risk and clear clinical justification. Capability of the patient or her/his parents/ legal representative(s) to understand the purpose and risks of the study, as judged by the recruiting physician Patients with negative blood culture or with detection of Gram-positive bacteria or mycobacteria or fungi in blood culture Patients with GNB in blood culture that are not resistant to third-generation cephalosporins (ceftriaxone) or carbapenems (meropenem) Patients with polymicrobial bloodstream infection (defined as isolation of ≥2 clinically significant microorganisms from blood cultures obtained within the same infectious episode; does not apply when additional organisms are considered likely contaminants rather than true pathogens (e.g. Staphylococcus epidermidis in a single bottle)) Patients with GNB detected in blood cultures and without systemic infection signs, in whom the microbiological finding is unambiguously interpreted as contamination not necessitating antimicrobial treatment Patients already recruited for concurrent participation in other clinical studies or trials Patients with known anaphylactic reactions or severe hypersensitivity to beta-lactam antibiotics Participants in whom initial screening suggests MDR GNB (growth on MDR screening agars or phenotypic resistance to ceftriaxone or meropenem), but confirmatory testing reveals susceptible organisms (GNB in blood culture that are not resistant to ceftriaxone or meropenem), will be considered post-enrolment exclusions. In stage 2, these participants will be followed for a further 24 hours for safety reasons, but will be otherwise excluded from the study. As they will not contribute to the study population, they will be replaced by another participant. In stage 1, safety reporting in participants excluded post-enrolment will depend on the national requirements in the study countries 80 and over: 80+ Year,Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 3 Month(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 17/12/2025 Ethikkommission der Aerztekammer des Saarlandes
Ethics Committee Address
Street address City Postal code Country
Faktoreistrasse 4 Saarbruecken 66111 Germany
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 26/07/2026 National Ethics Committee for Life and Health Sciences
Ethics Committee Address
Street address City Postal code Country
Avenue Jean Paul II Abidjan BP V 4 Cote Divoire
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 02/03/2026 Comite Nacional de Etica em Pesquisa na Saude
Ethics Committee Address
Street address City Postal code Country
861 Bissau Bissau 1004 Guinea-Bisseu
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 15/02/2026 University of Ilorin Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba Road Ilorin 1459 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All-cause mortality at 14 days after enrolment in patients with MDR GNB BSIs (stage 2 vs. stage 1) 14 days post-intervention
Secondary Outcome All-cause mortality at 14 days after enrolment 14 days post-intervention
Secondary Outcome Clinical cure within 7 days +/- 1 day of enrolment (clinical cure is defined as resolution or significant improvement of signs and symptoms of infection (e.g. fever, hemodynamic instability, organ dysfunction)), based on judgement of the responsible clinical investigator using a standardized clinical assessment sheet, in conjunction with laboratory parameters (stage 2 vs. stage 1) Microbiological cure (defined as clearance of bloodstream infection in follow-up blood cultures, i.e. ≥1 negative blood culture bottle(s) drawn ≥48 hours after enrolment and no further positive blood culture with the same pathogen identified) (stage 2 vs. stage 1) Adherence to the clinical algorithm by the treating physician(s) in stage 2 Appropriateness of antimicrobial therapy in both study stages All-cause mortality, stratified by pathogen (stage 2 vs stage 1) Adverse event profile of meropenem, ceftazidime-avibactam, cefiderocol and ceftazidime-avibactam plus aztreonam, as applicable (stage 2) Clonality of MDR GNB strains isolated from BSIs at the hospital level (stages 1 and 2 combined) Absolute number and distribution of MDR GNB in patients with BSIs (stages 1 and 2 combined) 7 days Post-intervention
Secondary Outcome All-cause mortality at 28 days after enrolment (stage 2 vs. stage 1) 28 days post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University and Teaching Hospital Cocody Bouldevard de lUniversite Abidjan Cote Divoire
Military Hospital Rue des Courgettes Abidjan Cote Divoire
Simao Mendes National University Hospital Bissau Bissau Guinea-Bisseu
Hospital Militar Principal Bissau Bissau Guinea-Bisseu
Obafemi Awolowo University Teaching Hospital Ilesa Road Ile Ife Nigeria
University of Ilorin Teaching Hospital Old Jebba Road Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Health EDCTP3 European Union Avenue de la Toison dOr Gulden Vlieslaan 56-60 Brussels Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Saarland University Campus Saarbruecken Germany University
COLLABORATORS
Name Street address City Postal code Country
Swiss TPH Kreuzstrasse 2 Allschwill Switzerland
LINQ Management GmbH Trendelenburgstrasse 14A Berlin Germany
Universidade Jean Piaget de Guinea Bissau Campus de Universidade Jean Piaget en Bissau Bissau Guinea-Bisseu
Joseph Sarwuan Tarka University Makurdi Gbajimba Road Benue State Nigeria
Centre for Malaria and Other Tropical DIseases University of Ilorin Teaching Hispital Complex Ilorin Nigeria
Obafemi Awolowo University Ibadan-Ife Road Ile Ife Nigeria
Institut Pasteur de Cote dIvoire Route de Dabou Abidjan Cote Divoire
Centre Suisse de Recherches Scientifique en Cote dIvoire Route de Dabou Abidjan Cote Divoire
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soeren L. Becker soeren.becker@uks.eu +4968411623900 Kirrberger Strasse 100
City Postal code Country Position/Affiliation
Homburg Germany Director of Insitute of Medical Microbiology and Hygiene
Role Name Email Phone Street address
Scientific Enquiries Aaron Aboderin diipo_aboderin@yahoo.com +2348036706730 Ilesha Road
City Postal code Country Position/Affiliation
Ife Nigeria Professor Obafemi Awolowo University Teaching Hospitals
Role Name Email Phone Street address
Public Enquiries Julia Buech j.buech@linq-management.com +491759271631 Trendelenburgstrasse 14A
City Postal code Country Position/Affiliation
Berlin Germany Communication LINQ Management GmbH
Role Name Email Phone Street address
Principal Investigator Aladje Balde aladje@gmail.com +245955343560 Campus de Universidade Jean Piaget en Bissau
City Postal code Country Position/Affiliation
Bissau Guinea-Bisseu President
Role Name Email Phone Street address
Principal Investigator Kalpy Julien Coulibaly kalpyjuliencoulibaly@ipci.ci +2250707915176 01 BP 490
City Postal code Country Position/Affiliation
Abidjan Cote Divoire Principal Investigator at Institut Pasteur de Cote dIvoire
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during the trial, after de-identification, will be made available upon reasonable request. Data that will be shared include participant-level clinical, laboratory, and study outcome data underlying the results reported in the primary publication, along with the study protocol and statistical analysis plan. Access to IPD will be granted to researchers who provide a methodologically sound proposal for secondary analysis. Requests will be reviewed and approved by the study sponsor and coordinating investigator, ensuring compliance with applicable ethical and data protection regulations. Data will be shared after publication of the primary results and in accordance with institutional and consortium data sharing agreements. Identifiable participant information will not be made available. Informed Consent Form,Study Protocol 25 years, May 2025 start and May 2050 end Access to individual participant data will be granted upon reasonable request to qualified researchers who submit a methodologically sound proposal for a clearly defined scientific question. Requests must include a detailed analysis plan and demonstrate appropriate scientific rationale. Proposals will be reviewed and approved by the study sponsor and the principal/coordinating investigator. Data sharing will occur after publication of the primary study results and in accordance with applicable ethical approvals, institutional policies, and data protection regulations (including GDPR where applicable). Data will be provided in de-identified form only, and data use will be limited to the approved purpose as outlined in the request. A data sharing agreement may be required prior to data transfer.
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 Official scientific title 23/07/2026 PACTR Admin Combating Multidrug-Resistant Gram-Negative Bacteria in Africa through Diagnostic and Antimicrobial Stewardship: A multicentre, prospective quasi-experimental two-stage study Combating Multidrug-Resistant Gram-Negative Bacteria in Africa through Diagnostic and Antimicrobial Stewardship: A multicentre, prospective quasi-experimental two-stage study
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 16/07/2026 We have two groups, the most suitable intervention assignment would then be "parallel". Please note that the two groups (one group in stage 1, one group in stage 2) will be assessed at different time points. Single Group Parallel: different groups receive different interventions at same time during study
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 Added post-intervention as per request. Primary Outcome, All-cause mortality at 14 days after enrolment in patients with MDR GNB BSIs (stage 2 vs. stage 1) , 14 days Primary Outcome, All-cause mortality at 14 days after enrolment in patients with MDR GNB BSIs (stage 2 vs. stage 1) , 14 days post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/07/2026 Will divide into separate outcomes, changed according to request Secondary Outcome, All-cause mortality at 28 days after enrolment (stage 2 vs. stage 1) Clinical cure within 7 days +/- 1 day of enrolment (clinical cure is defined as resolution or significant improvement of signs and symptoms of infection (e.g. fever, hemodynamic instability, organ dysfunction)), based on judgement of the responsible clinical investigator using a standardized clinical assessment sheet, in conjunction with laboratory parameters (stage 2 vs. stage 1) Microbiological cure (defined as clearance of bloodstream infection in follow-up blood cultures, i.e. ≥1 negative blood culture bottle(s) drawn ≥48 hours after enrolment and no further positive blood culture with the same pathogen identified) (stage 2 vs. stage 1) Adherence to the clinical algorithm by the treating physician(s) in stage 2 Appropriateness of antimicrobial therapy in both study stages All-cause mortality, stratified by pathogen (stage 2 vs stage 1) Adverse event profile of meropenem, ceftazidime-avibactam, cefiderocol and ceftazidime-avibactam plus aztreonam, as applicable (stage 2) Clonality of MDR GNB strains isolated from BSIs at the hospital level (stages 1 and 2 combined) Absolute number and distribution of MDR GNB in patients with BSIs (stages 1 and 2 combined) , 7 days, 14 days, 28 days Secondary Outcome, All-cause mortality at 14 days after enrolment , 14 days
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 Will divide into separate outcomes, changed according to request. Added post-intervention. Secondary Outcome, All-cause mortality at 14 days after enrolment , 14 days Secondary Outcome, All-cause mortality at 14 days after enrolment , 14 days post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/07/2026 Will divide into separate outcomes, changed according to request Secondary Outcome, Clinical cure within 7 days +/- 1 day of enrolment (clinical cure is defined as resolution or significant improvement of signs and symptoms of infection (e.g. fever, hemodynamic instability, organ dysfunction)), based on judgement of the responsible clinical investigator using a standardized clinical assessment sheet, in conjunction with laboratory parameters (stage 2 vs. stage 1) Microbiological cure (defined as clearance of bloodstream infection in follow-up blood cultures, i.e. ≥1 negative blood culture bottle(s) drawn ≥48 hours after enrolment and no further positive blood culture with the same pathogen identified) (stage 2 vs. stage 1) Adherence to the clinical algorithm by the treating physician(s) in stage 2 Appropriateness of antimicrobial therapy in both study stages All-cause mortality, stratified by pathogen (stage 2 vs stage 1) Adverse event profile of meropenem, ceftazidime-avibactam, cefiderocol and ceftazidime-avibactam plus aztreonam, as applicable (stage 2) Clonality of MDR GNB strains isolated from BSIs at the hospital level (stages 1 and 2 combined) Absolute number and distribution of MDR GNB in patients with BSIs (stages 1 and 2 combined) , 7 days
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 Will divide into separate outcomes, changed according to request; added post-intervention Secondary Outcome, Clinical cure within 7 days +/- 1 day of enrolment (clinical cure is defined as resolution or significant improvement of signs and symptoms of infection (e.g. fever, hemodynamic instability, organ dysfunction)), based on judgement of the responsible clinical investigator using a standardized clinical assessment sheet, in conjunction with laboratory parameters (stage 2 vs. stage 1) Microbiological cure (defined as clearance of bloodstream infection in follow-up blood cultures, i.e. ≥1 negative blood culture bottle(s) drawn ≥48 hours after enrolment and no further positive blood culture with the same pathogen identified) (stage 2 vs. stage 1) Adherence to the clinical algorithm by the treating physician(s) in stage 2 Appropriateness of antimicrobial therapy in both study stages All-cause mortality, stratified by pathogen (stage 2 vs stage 1) Adverse event profile of meropenem, ceftazidime-avibactam, cefiderocol and ceftazidime-avibactam plus aztreonam, as applicable (stage 2) Clonality of MDR GNB strains isolated from BSIs at the hospital level (stages 1 and 2 combined) Absolute number and distribution of MDR GNB in patients with BSIs (stages 1 and 2 combined) , 7 days Secondary Outcome, Clinical cure within 7 days +/- 1 day of enrolment (clinical cure is defined as resolution or significant improvement of signs and symptoms of infection (e.g. fever, hemodynamic instability, organ dysfunction)), based on judgement of the responsible clinical investigator using a standardized clinical assessment sheet, in conjunction with laboratory parameters (stage 2 vs. stage 1) Microbiological cure (defined as clearance of bloodstream infection in follow-up blood cultures, i.e. ≥1 negative blood culture bottle(s) drawn ≥48 hours after enrolment and no further positive blood culture with the same pathogen identified) (stage 2 vs. stage 1) Adherence to the clinical algorithm by the treating physician(s) in stage 2 Appropriateness of antimicrobial therapy in both study stages All-cause mortality, stratified by pathogen (stage 2 vs stage 1) Adverse event profile of meropenem, ceftazidime-avibactam, cefiderocol and ceftazidime-avibactam plus aztreonam, as applicable (stage 2) Clonality of MDR GNB strains isolated from BSIs at the hospital level (stages 1 and 2 combined) Absolute number and distribution of MDR GNB in patients with BSIs (stages 1 and 2 combined) , 7 days Post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 07/07/2026 Will divide into separate outcomes, changed according to request Secondary Outcome, All-cause mortality at 28 days after enrolment (stage 2 vs. stage 1) , 28 days
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 16/07/2026 Will divide into separate outcomes, changed according to request. Added post-intervention. Secondary Outcome, All-cause mortality at 28 days after enrolment (stage 2 vs. stage 1) , 28 days Secondary Outcome, All-cause mortality at 28 days after enrolment (stage 2 vs. stage 1) , 28 days post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2026 Previously not entered. This is the ethics committee in Cote dIvoire. FALSE, National Ethics Committee for Life and Health Sciences, Avenue Jean Paul II, Abidjan, BP V 4, Cote Divoire, 26 Jul 2026, , +2250505636737, cnesvscotedivoire@gmail.com,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2026 Previously not included. Ethics committee for Guinea Bissau TRUE, Comite Nacional de Etica em Pesquisa na Saude, 861 Bissau, Bissau, 1004, Guinea-Bisseu, , 02 Mar 2026, +245966938511, djicoblama.spccm@gmail.com, 43604_39975_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 07/07/2026 Previously not included. Added as per request. TRUE, University of Ilorin Teaching Hospital Health Research Ethics Committee , Old Jebba Road, Ilorin, 1459, Nigeria, , 15 Feb 2026, +2348035727069, droaafolabi@yahoo.com, 43604_39977_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 06/07/2026 Principal Investigator for Guinea-Bissau added as requested. Principal Investigator, Aladje, Balde, Prof., aladje@gmail.com, , +245955343560, Campus de Universidade Jean Piaget en Bissau, Bissau, , Guinea-Bisseu, President
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 06/07/2026 Principal Investigator for Côte d'Ivoire added as requested. Principal Investigator, Kalpy Julien, Coulibaly, Prof., kalpyjuliencoulibaly@ipci.ci, , +2250707915176, 01 BP 490, Abidjan, , Cote Divoire, Principal Investigator at Institut Pasteur de Cote dIvoire
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 23/07/2026 PACTR Admin ndividual participant data collected during the trial, after de-identification, will be made available upon reasonable request. Data that will be shared include participant-level clinical, laboratory, and study outcome data underlying the results reported in the primary publication, along with the study protocol and statistical analysis plan. Access to IPD will be granted to researchers who provide a methodologically sound proposal for secondary analysis. Requests will be reviewed and approved by the study sponsor and coordinating investigator, ensuring compliance with applicable ethical and data protection regulations. Data will be shared after publication of the primary results and in accordance with institutional and consortium data sharing agreements. Identifiable participant information will not be made available. Individual participant data collected during the trial, after de-identification, will be made available upon reasonable request. Data that will be shared include participant-level clinical, laboratory, and study outcome data underlying the results reported in the primary publication, along with the study protocol and statistical analysis plan. Access to IPD will be granted to researchers who provide a methodologically sound proposal for secondary analysis. Requests will be reviewed and approved by the study sponsor and coordinating investigator, ensuring compliance with applicable ethical and data protection regulations. Data will be shared after publication of the primary results and in accordance with institutional and consortium data sharing agreements. Identifiable participant information will not be made available.