Experiences and challenges of joining a platform trial of Staph aureus bacteraemia in an LMIC- South Africa's experience of the SNAP trial
Introduction: Multisite adaptive platform trials are increasingly recognised as an important contribution to infectious diseases research. To ensure generalisability, it is important to include sites from Low- and Middle-Income Counties (LMIC). The involvement of LMIC countries from study inception...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-03-01
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| Series: | International Journal of Infectious Diseases |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971224006635 |
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| Summary: | Introduction: Multisite adaptive platform trials are increasingly recognised as an important contribution to infectious diseases research. To ensure generalisability, it is important to include sites from Low- and Middle-Income Counties (LMIC). The involvement of LMIC countries from study inception is critical to ensure trial design and protocols are feasible in resource limited settings. Drug trials of patients with bacteraemia are challenging in LMIC due to resource constraints and lack of laboratory infrastructure. South Africa is the first LMIC to join the SNAP adaptive platform trial of Staphylococcus aureus bacteraemia (SAB) following an ex-gratia payment of AUS$ 50,000. We report initial data and challenges encountered during this process. Methods: Funding was received in early 2023 and following full regulatory and ethical approval, the first patient was enrolled in August 2023. One site is currently active, with 1 part-time doctor and 1 part-time study co-ordinator. Two other sites (1 paediatric) have received all approvals and are nearing activation. Multiple applications have been made for further funding. Results: The global SNAP trial is predominantly recruiting in High Income Countries (HIC), 6259 adults have been screened of whom 343 (5%) died prior to pathogen identification, 1732 (28%) were not enrolled, largely due to inability to obtain informed consent. 2054 (33%) were enrolled in the observational registry and 2129 (34%) were randomised. At Helen Joseph Hospital in Johannesburg, 70 patients have been screened (6 (9%) MRSA); 16 (23%) died prior to pathogen identification, 7(10%) could not be enrolled due to non-availability of study staff, 25(36%) others were enrolled in the registry, with most ineligible for randomisation because of inability to obtain informed consent within 72hrs of blood draw, and 13 (19%) were randomised to the SNAP platform. Collection of 90-day mortality data (primary outcome) is 100%. Discussion: Enrolment of participants to bacteraemia trials in LMIC is possible with minimal funding. However, eligibility for randomisation within 72hrs of blood draw is difficult. Frequent stock-outs of media and diffusion disks are key reasons for delayed pathogen identification. Enrolment at weekends is challenging with a small staff compliment. Mortality prior to pathogen identification is high (23%) compared to HIC (5%). This may be a function of delayed presentation to hospital and the delay in pathogen identification in a low resource setting. Ongoing funding for trials such as SNAP is challenging and puts future participation of this important population at risk. Future funding should include capacity building for laboratories to ensure timely identification of pathogens. Conclusion: Despite challenges related to lack of resources and ongoing funding, LMICs can successfully participate in platform bacteraemia trials. |
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| ISSN: | 1201-9712 |