Azithromycin to prevent post-discharge morbidity and mortality in Kenyan children: A protocol for a randomised, double-blind, placebo-controlled trial (the Toto Bora trial)

BMJ Open

Volumn 7, Issue 12, 2017, Pages

  Pavlinac, Patricia B ^a   Singa, Benson O ^b,c   John Stewart, Grace C ^a,d   Richardson, Barbra A ^a   Brander, Rebecca L ^a   McGrath, Christine J ^a   Tickell, Kirkby D ^a,c   Amondi, Mary ^b   Rwigi, Doreen ^b   Babigumira, Joseph B ^a   Kariuki, Sam ^b   Nduati, Ruth ^e   Walson, Judd L ^a,c,d  

^a UNIVERSITY OF WASHINGTON   (United States)

^b KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^c The Childhood Acute Illness and Nutrition Network (CHAIN)   (Kenya)

^d UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF NAIROBI   (Kenya)

Author keywords

child mortality; post discharge interventions; targeted empiric antibiotic therapy; toto bora trial

Indexed keywords

AZITHROMYCIN; PLACEBO; ANTIINFECTIVE AGENT;

ANTIBIOTIC PROPHYLAXIS; ANTIBIOTIC RESISTANCE; ARTICLE; BACTERIUM ISOLATE; CHILD; CHILDHOOD MORTALITY; CONFIDENTIALITY; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DOUBLE BLIND PROCEDURE; ESCHERICHIA COLI; FEMALE; HOSPITAL DISCHARGE; HOSPITAL READMISSION; HUMAN; INFANT; INTENTION TO TREAT ANALYSIS; INTESTINE INFECTION; KENYAN; MAJOR CLINICAL STUDY; MALE; MORBIDITY; NONHUMAN; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; STREPTOCOCCUS PNEUMONIAE; CHILD DEATH; HOSPITALIZATION; INFECTION; KENYA; METHODOLOGY; MICROBIOLOGY; MORTALITY; PROPORTIONAL HAZARDS MODEL;

ANTI-BACTERIAL AGENTS; AZITHROMYCIN; CHILD; DOUBLE-BLIND METHOD; DRUG RESISTANCE, MICROBIAL; ESCHERICHIA COLI; FEMALE; HOSPITALIZATION; HUMANS; INFANT; INFANT DEATH; INFECTION; KENYA; MALE; MORBIDITY; PATIENT DISCHARGE; PATIENT READMISSION; PROPORTIONAL HAZARDS MODELS; RESEARCH DESIGN; STREPTOCOCCUS PNEUMONIAE;

EID: 85051948366     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2017-019170     Document Type: Article

References (34)

1. GBD 2015 Child Mortality Collaborators. Global, regional, national, and selected subnational levels of stillbirths, neonatal, infant, and under-5 mortality, 1980-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 2016;388:1725-74.
2. Moïsi JC, Gatakaa H, Berkley JA, et al. Excess child mortality after discharge from hospital in Kilifi, Kenya: a retrospective cohort analysis. Bull World Health Organ 2011;89:725-32.
3. Veirum JE, Sodeman M, Biai S, et al. Increased mortality in the year following discharge from a paediatric ward in Bissau, Guinea-Bissau. Acta Paediatr 2007;96:1832-8.
4. Snow RW, Howard SC, Mung'Ala-Odera V, et al. Paediatric survival and re-admission risks following hospitalisation on the Kenyan coast. Trop Med Int Health 2000;5:377-83.
5. Zucker JR, Lackritz EM, Ruebush TK, et al. Childhood mortality during and after hospitalisation in western Kenya: effect of malaria treatment regimens. Am J Trop Med Hyg 1996;55:655-60.
6. Islam MA, Rahman MM, Mahalanabis D, et al. Death in a diarrhoeal cohort of infants and young children soon after discharge from hospital: risk factors and causes by verbal autopsy. J Trop Pediatr 1996;42:342-7.
7. Villamor E, Misegades L, Fataki MR, et al. Child mortality in relation to HIV infection, nutritional status, and socio-economic background. Int J Epidemiol 2005;34:61-8.
8. Phiri KS, Calis JC, Faragher B, et al. Long term outcome of severe anaemia in Malawian children. PLoS One 2008;3:e2903.
9. Wiens MO, Pawluk S, Kissoon N, et al. Pediatric post-discharge mortality in resource poor countries: a systematic review. PLoS One 2013;8:e66698.
10. Bwakura-Dangarembizi M, Kendall L, Bakeera-Kitaka S, et al. A randomized trial of prolonged co-trimoxazole in HIV-infected children in Africa. N Engl J Med 2014;370:41-53.
11. Walker AS, Mulenga V, Ford D, et al. The impact of daily cotrimoxazole prophylaxis and antiretroviral therapy on mortality and hospital admissions in HIV-infected Zambian children. Clin Infect Dis 2007;44:1361-7.
12. Chintu C, Bhat GJ, Walker AS, et al. Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double-blind randomised placebo-controlled trial. Lancet 2004;364:1865-71.
13. Trehan I, Goldbach HS, LaGrone LN, et al. Antibiotics as part of the management of severe acute malnutrition. N Engl J Med 2013;368:425-35.
14. Lockman S, Hughes M, Powis K, et al. Effect of co-trimoxazole on mortality in HIV-exposed but uninfected children in Botswana (the Mpepu Study): a double-blind, randomised, placebo-controlled trial. Lancet Glob Health 2017;5:e491-e500.
15. Berkley JA, Ngari M, Thitiri J, et al. Daily co-trimoxazole prophylaxis to prevent mortality in children with complicated severe acute malnutrition: a multicentre, double-blind, randomised placebocontrolled trial. Lancet Glob Health 2016;4:e464-e473.
16. Porco TC, Gebre T, Ayele B, et al. Effect of mass distribution of azithromycin for trachoma control on overall mortality in Ethiopian children: a randomized trial. JAMA 2009;302:962-8.
17. Keenan JD, Ayele B, Gebre T, et al. Childhood mortality in a cohort treated with mass azithromycin for trachoma. Clin Infect Dis 2011;52:883-8.
18. O'Brien KL, Nohynek H. World Health Organisation Pneumococcal Vaccine Trials Carraige Working Group. Report from a WHO working group: standard method for detecting upper respiratory carriage of Streptococcus pneumoniae. Pediatr Infect Dis J 2003;22:133-40.
19. Satzke C, Turner P, Virolainen-Julkunen A, et al. Standard method for detecting upper respiratory carriage of Streptococcus pneumoniae: updated recommendations from the World Health Organisation Pneumococcal Carriage Working Group. Vaccine 2013;32:165-79.
20. Serina P, Riley I, Stewart A, et al. A shortened verbal autopsy instrument for use in routine mortality surveillance systems. BMC Med 2015;13:302.
21. Serina P, Riley I, Stewart A, et al. Improving performance of the Tariff Method for assigning causes of death to verbal autopsies. BMC Med 2015;13:291.
22. WHO. Making choices in health: WHO guide to cost-effectiveness analysis, 2003.
23. Murray CJ, Vos T, Lozano R, et al. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2197-223.
24. Salomon JA, Vos T, Hogan DR, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet 2012;380:2129-43.
25. Gold M, Siegel JE, Russell LB, et al. Cost-effectiveness in health and medicine. New York: Oxford University Press, 1996.
26. Drummond MF, Torrance GW, O'Brien BJ, et al. Methods for the economic evaluation of healthcare programmes. 3rd edn. New York: Oxford University Press, 2005.
27. Laxminarayan R, Mills AJ, Breman JG, et al. Advancement of global health: key messages from the Disease Control Priorities Project. Lancet 2006;367:1193-208.
28. Jamison DT, Measham A, Alleyne G, et al. Disease control priorities in developing countries. 2nd edn: Oxford University Press, 2006.
29. Abdullahi O, Karani A, Tigoi CC, et al. The prevalence and risk factors for pneumococcal colonisation of the nasopharynx among children in Kilifi District, Kenya. PLoS One 2012;7:e30787.
30. Rodrigues F, Foster D, Caramelo F, et al. Progressive changes in pneumococcal carriage in children attending daycare in Portugal after 6 years of gradual conjugate vaccine introduction show falls in most residual vaccine serotypes but no net replacement or trends in diversity. Vaccine 2012;30:3951-6.
31. Grivea IN, Tsantouli AG, Michoula AN, et al. Dynamics of Streptococcus pneumoniae nasopharyngeal carriage with high heptavalent pneumococcal conjugate vaccine coverage in Central Greece. Vaccine 2011;29:8882-7.
32. Skalet AH, Cevallos V, Ayele B, et al. Antibiotic selection pressure and macrolide resistance in nasopharyngeal Streptococcus pneumoniae: a cluster-randomized clinical trial. PLoS Med 2010;7:e1000377.
33. Adetifa IM, Antonio M, Okoromah CA, et al. Pre-vaccination nasopharyngeal pneumococcal carriage in a Nigerian population: epidemiology and population biology. PLoS One 2012;7:e30548.
34. Hill PC, Akisanya A, Sankareh K, et al. Nasopharyngeal carriage of Streptococcus pneumoniae in Gambian villagers. Clin Infect Dis 2006;43:673-9.