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Abstracts of Oral Presentations
OA-429 High mortality in African infants living with HIV hospitalized with severe pneumonia
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  1. Bwendo Nduna1,
  2. Cinta Moraleda2,
  3. Jahit Sacaral3,
  4. Judith Beinomugisha4,
  5. Idah Zulu5,
  6. Moses Chitamatanga6,
  7. Pui-Ying Iroh Tam7,
  8. Chimwemwe Chawinga8,
  9. Sheila Fernandez9,
  10. Álvaro Ballesteros2,
  11. Alfeu Passanduca3,
  12. Abner Tagoola10,
  13. Raul Atibo11,
  14. Denis Nansera12,
  15. Mutsa Bwakura-Dangarembizi6,
  16. Lughano Gambi7,
  17. Tisungane Mvalo8,
  18. Lola Madrid2,
  19. Belinda Macmillan13,
  20. Victor Musiime14,
  21. Raoul Moh15,
  22. Chris W Buck3,16,
  23. Chishala Chabala5,
  24. Alfredo Tagarro2,
  25. Pablo Rojo2,17,18,
  26. Trial Empirical19
  1. 1Arthur Davison Children’s Hospital, Zambia
  2. 2Foundation for Biomedical Research of the Hospital Universitario 12 de Octubre-Hospital 12 de Octubre Health Research Institute (i+12), Spain
  3. 3Universidade Eduardo Mondlane Faculdade de Medicina, Mozambique
  4. 4China Uganda Friendship Hospital, Uganda
  5. 5University of Zambia and University Teaching Hospital-Herpez, Zambia
  6. 6University of Zimbabwe Clinical Research Centre, Zimbabwe
  7. 7Malawi-Liverpool-Wellcome Research Programme, Malawi
  8. 8Lilongwe Medical Relief Fund Trust, Malawi
  9. 9Fundaçao Manhiça, Mozambique
  10. 10Jinja Regional Referral Hospital, Uganda
  11. 11Hospital Central de Nampula, Mozambique
  12. 12Mbarara Regional Referral Hospital, Uganda
  13. 13Hospital Central de Beira, Mozambique
  14. 14Makerere University (MU), Uganda
  15. 15Association PAC-CI (PACCI), School of Medicine, Cote d’Ivoire
  16. 16University of California Los Angeles David Geffen School of Medicine, USA
  17. 17Servicio Madrileño de Salud (SERMAS), Spain
  18. 18Complutense University, Spain
  19. 19Empirical Clinical Trial Group

Abstract

Background Children with advanced HIV disease (AHD) are at an increased risk of morbidity and mortality. We describe mortality rates among infants with AHD hospitalized with severe pneumonia.

Methods EMPIRICAL is an ongoing Phase II-III, open-label randomized factorial (2×2) trial supported by EDCTP (GA RIA2017MC_2013/#NCT03915366) to assess the impact of empirical treatment against cytomegalovirus and tuberculosis in infants living with HIV hospitalized with severe pneumonia. The primary endpoint is all-cause mortality at 15-days and 12-months post enrolment. Recruitment is on-going and includes 22 hospitals from 6 African countries (Côte d’Ivoire, Malawi, Mozambique, Uganda, Zambia, Zimbabwe).

Results In March 2023, 431 infants had been recruited and 429 were included in analysis. Their median age was 4.36 months (IQR, 3.18–7.08) and 49% were female; 164 (38%) had a history of maternal and/or infant prophylaxis for prevention-mother-to-child-transmission (PMTCT); 306 (71%) were newly diagnosed of HIV during hospitalization; Median HIV viral load and CD4% were 6.3 logs copies/mL (IQR, 5.8–7.0) and 14.4% (IQR, 9.9–21.6) respectively. 196 (46%) of the infants died within a 6 months follow up period (2.16 months (IQR, 0.26–6.16), 110 (56%) in the first admission and 86 (44%) after it. The main register causes of death are pneumonia 91 (46%), sepsis 32 (16%) and gastroenteritis 10 (5%). An in-depth analysis of deaths is ongoing, including minimally invasive tissue sampling, microbiological and histopathological evaluation.

Conclusion Children living with HIV and severe pneumonia have a very high mortality, both during the initial hospitalization and after hospital discharge. Measures focused on earlier identification and treatment as well as focused on decreasing post-discharge mortality are urgently needed. EMPIRICAL will report on the survival benefit of cytomegalovirus and tuberculosis treatment at trial conclusion. Emphasis should be put into reducing missed opportunities for PMTCT; strengthening early infant diagnosis and antiretrovirals initiation for those who fail PMTCT.

https://doi.org/10.1136/bmjgh-2023-EDC.34

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