Twenty-four Month Outcomes of Extended- Versus Standard-course Antibiotic Therapy in Children Hospitalized With Pneumonia in High-risk Settings: A Randomized Controlled Trial

Author:

Kok Hing C.12ORCID,McCallum Gabrielle B.1,Yerkovich Stephanie T.13,Grimwood Keith45,Fong Siew M.2,Nathan Anna M.6,Byrnes Catherine A.78,Ware Robert S.4,Nachiappan Nachal9,Saari Noorazlina9,Morris Peter S.110,Yeo Tsin W.111,Oguoma Victor M.112,Masters I. Brent313,de Bruyne Jessie A.6,Eg Kah P.6,Lee Bilawara114,Ooi Mong H.1516,Upham John W.17,Torzillo Paul J.1819,Chang Anne B.1313

Affiliation:

1. From the Child and Maternal Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia

2. Department of Pediatrics, Sabah Women and Children’s Hospital, Kota Kinabalu, Sabah, Malaysia

3. Australian Centre for Health Services Innovation, Queensland University of Technology, Brisbane, Queensland, Australia

4. School of Medicine and Dentistry, Griffith University, Gold Coast, Queensland, Australia

5. Departments of Infectious Diseases and Pediatrics, Gold Coast Health, Gold Coast, Queensland,, Australia

6. Department of Pediatrics, University of Malaya, Kuala Lumpur, Malaysia

7. Department of Pediatrics, University of Auckland, Auckland, New Zealand

8. Respiratory Department, Starship Children’s Hospital, Auckland, New Zealand

9. Department of Pediatrics, Tengku Ampuan Rahimah Hospital, Klang, Selangor, Malaysia

10. Department of Pediatrics, Royal Darwin Hospital, Darwin, Northern Territory, Australia

11. Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore

12. Poche Centre for Indigenous Health, The University of Queensland, Brisbane, Queensland, Australia

13. Department of Respiratory and Sleep Medicine, Queensland Children’s Hospital, Brisbane, Queensland, Australia

14. First Nations Leadership & Engagement, Charles Darwin University, Darwin, Northern Territory, Australia

15. Department of Pediatrics, Sarawak General Hospital, Sarawak, Malaysia

16. Institute of Health and Community Medicine, Universiti Malaysia Sarawak, Sarawak, Malaysia

17. Diamantina Institute, The University of Queensland, and Translational Research Institute, Brisbane, Queensland, Australia

18. Central Clinical School, University of Sydney, Sydney, New South Wales, Australia

19. Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.

Abstract

Background: Pediatric community-acquired pneumonia (CAP) can lead to long-term respiratory sequelae, including bronchiectasis. We determined if an extended (13–14 days) versus standard (5–6 days) antibiotic course improves long-term outcomes in children hospitalized with CAP from populations at high risk of chronic respiratory disease. Methods: We undertook a multicenter, double-blind, superiority, randomized controlled trial involving 7 Australian, New Zealand, and Malaysian hospitals. Children aged 3 months to ≤5 years hospitalized with radiographic-confirmed CAP who received 1–3 days of intravenous antibiotics, then 3 days of oral amoxicillin-clavulanate, were randomized to either extended-course (8-day oral amoxicillin-clavulanate) or standard-course (8-day oral placebo) arms. Children were reviewed at 12 and 24 months. The primary outcome was children with the composite endpoint of chronic respiratory symptoms/signs (chronic cough at 12 and 24 months; ≥1 subsequent hospitalized acute lower respiratory infection by 24 months; or persistent and/or new chest radiographic signs at 12-months) at 24-months postdischarge, analyzed by intention-to-treat, where children with incomplete follow-up were assumed to have chronic respiratory symptoms/signs (“worst-case” scenario). Results: A total of 324 children were randomized [extended-course (n = 163), standard-course (n = 161)]. For our primary outcome, chronic respiratory symptoms/signs occurred in 97/163 (60%) and 94/161 (58%) children in the extended-courses and standard-courses, respectively [relative risk (RR) = 1.02, 95% confidence interval (CI): 0.85–1.22]. Among children where all sub-composite outcomes were known, chronic respiratory symptoms/signs between groups, RR = 1.10, 95% CI: 0.69–1.76 [extended-course = 27/93 (29%) and standard-course = 24/91 (26%)]. Additional sensitivity analyses also revealed no between-group differences. Conclusion: Among children from high-risk populations hospitalized with CAP, 13–14 days of antibiotics (versus 5–6 days), did not improve long-term respiratory outcomes.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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