LOGIN TO YOUR ACCOUNT

Username
Password
Remember Me
Or use your Academic/Social account:

CREATE AN ACCOUNT

Or use your Academic/Social account:

Congratulations!

You have just completed your registration at OpenAire.

Before you can login to the site, you will need to activate your account. An e-mail will be sent to you with the proper instructions.

Important!

Please note that this site is currently undergoing Beta testing.
Any new content you create is not guaranteed to be present to the final version of the site upon release.

Thank you for your patience,
OpenAire Dev Team.

Close This Message

CREATE AN ACCOUNT

Name:
Username:
Password:
Verify Password:
E-mail:
Verify E-mail:
*All Fields Are Required.
Please Verify You Are Human:
fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Leung, Jacqueline M.; Hong, Chau Tran Thi; Trung, Nghia Ho Dang; Thi, Hoa Nhu; Minh, Chau Nguyen Ngoc; Thi, Thuy Vu; Hong, Dinh Thanh; Man, Dinh Nguyen Huy; Knowles, Sarah C. L.; Wolbers, Marcel; Hoang, Nhat Le Thanh; Thwaites, Guy; Graham, Andrea L.; Baker, Stephen (2016)
Publisher: BioMed Central
Journal: Trials
Languages: English
Types: Article
Subjects: Medicine (miscellaneous), Co-infection, Albendazole, Deworming, Soil-transmitted helminths, Study Protocol, Diarrhea, Pharmacology (medical)

Classified by OpenAIRE into

mesheuropmc: parasitic diseases
Background Anthelmintics are one of the more commonly available classes of drugs to treat infections by parasitic helminths (especially nematodes) in the human intestinal tract. As a result of their cost-effectiveness, mass school-based deworming programs are becoming routine practice in developing countries. However, experimental and clinical evidence suggests that anthelmintic treatments may increase susceptibility to other gastrointestinal infections caused by bacteria, viruses, or protozoa. Hypothesizing that anthelmintics may increase diarrheal infections in treated children, we aim to evaluate the impact of anthelmintics on the incidence of diarrheal disease caused by viral and bacterial pathogens in school children in southern Vietnam. Methods/design This is a randomized, double-blinded, placebo-controlled trial to investigate the effects of albendazole treatment versus placebo on the incidence of viral- and bacterial-induced diarrhea in 350 helminth-infected and 350 helminth-uninfected Vietnamese school children aged 6–15 years. Four hundred milligrams of albendazole, or placebo treatment will be administered once every 3 months for 12 months. At the end of 12 months, all participants will receive albendazole treatment. The primary endpoint of this study is the incidence of diarrheal disease assessed by 12 months of weekly active and passive case surveillance. Secondary endpoints include the prevalence and intensities of helminth, viral, and bacterial infections, alterations in host immunity and the gut microbiota with helminth and pathogen clearance, changes in mean z scores of body weight indices over time, and the number and severity of adverse events. Discussion In order to reduce helminth burdens, anthelmintics are being routinely administered to children in developing countries. However, the effects of anthelmintic treatment on susceptibility to other diseases, including diarrheal pathogens, remain unknown. It is important to monitor for unintended consequences of drug treatments in co-infected populations. In this trial, we will examine how anthelmintic treatment impacts host susceptibility to diarrheal infections, with the aim of informing deworming programs of any indirect effects of mass anthelmintic administrations on co-infecting enteric pathogens. Trial registration ClinicalTrials.gov: NCT02597556. Registered on 3 November 2015. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1406-1) contains supplementary material, which is available to authorized users.
  • The results below are discovered through our pilot algorithms. Let us know how we are doing!

    • 1. Pullan RL, Smith JL, Jasrasaria R, Brooker SJ. Global numbers of infection and disease burden of soil transmitted helminth infections in 2010. Parasites & vectors. 2014;7(1):37. doi:10.1186/1756-3305-7-37.
    • 2. Bundy DAP, Chan MS, Medley GF, Jamison D, Savioli L. In: Global epidemiology of infectious disease: Global burden of disease volume IV. Murray CJL, Lopez AD, Mathers CD, editor. Geneva: World Health Organization; 2004. Intestinal nematode infections; pp. 243-300.
    • 3. Chan MS, Medley GF, Jamison D, Bundy DA. The evaluation of potential global morbidity attributable to intestinal nematode infections. Parasitology. 1994;109(Pt 3):373-87.
    • 4. Brooker S. Estimating the global distribution and disease burden of intestinal nematode infections: adding up the numbers-a review. Int J Parasitol. 2010;40(10):1137-44. doi:10.1016/j.ijpara.2010.04.004.
    • 5. Anderson RM, May RMM. Infectious diseases of humans. Oxford: Oxford University Press; 1991.
    • 6. McKay DM. The beneficial helminth parasite? Parasitology. 2006;132(Pt 1):1-12. doi:10.1017/S003118200500884X.
    • 7. Nacher M. Worms and malaria: resisting the temptation to generalize. Trends Parasitol. 2006;22(8):350-1. doi:10.1016/j.pt.2006.06.003. author reply 1-2.
    • 8. Broadhurst MJ, Leung JM, Kashyap V, McCune JM, Mahadevan U, McKerrow JH, et al. IL-22+ CD4+ T cells are associated with therapeutic Trichuris trichiura infection in an ulcerative colitis patient. Sci Transl Med. 2010;2(60): 60ra88. doi:10.1126/scitranslmed.3001500.
    • 9. Montresor A, Crompton DWT, Gyorkos TW, Savioli L. Helminth Control in School-Age Children: A Guide for Managers of Control Programmes. 2002. Geneva: World Health Organization.
    • 10. Taylor-Robinson DC, Maayan N, Soares-Weiser K, Donegan S, Garner P. Deworming drugs for soil-transmitted intestinal worms in children: effects on nutritional indicators, haemoglobin, and school performance. The Cochrane database of systematic reviews. 2015;7, CD000371. doi:10.1002/ 14651858.CD000371.pub6.
    • 11. Mwangi TW, Bethony JM, Brooker S. Malaria and helminth interactions in humans: an epidemiological viewpoint. Ann Trop Med Parasitol. 2006;100(7): 551-70. doi:10.1179/136485906X118468.
    • 12. Hotez PJ, Molyneux DH, Fenwick A, Ottesen E, Ehrlich Sachs S, Sachs JD. Incorporating a rapid-impact package for neglected tropical diseases with programs for HIV/AIDS, tuberculosis, and malaria. PLoS Med. 2006;3(5), e102. doi:10.1371/journal.pmed.0030102.
    • 13. Pedersen AB, Fenton A. The role of antiparasite treatment experiments in assessing the impact of parasites on wildlife. Trends Parasitol. 2015;31(5): 200-11. doi:10.1016/j.pt.2015.02.004.
    • 14. Knowles SC, Fenton A, Petchey OL, Jones TR, Barber R, Pedersen AB. Stability of within-host-parasite communities in a wild mammal system. Proceedings Biological Sciences/The Royal Society. 2013;280(1762):20130598. doi:10.1098/rspb.2013.0598.
    • 15. Pedersen AB, Antonovics J. Anthelmintic treatment alters the parasite community in a wild mouse host. Biol Lett. 2013;9(4):20130205. doi:10.1098/rsbl.2013.0205.
    • 16. Blackwell AD, Martin M, Kaplan H, Gurven M. Antagonism between two intestinal parasites in humans: the importance of co-infection for infection risk and recovery dynamics. Proceedings Biological Sciences/The Royal Society. 2013;280(1769):20131671. doi:10.1098/rspb.2013.1671.
    • 17. Ezenwa VO, Jolles AE. Opposite effects of anthelmintic treatment on microbial infection at individual versus population scales. Science. 2015; 347(6218):175-7. doi:10.1126/science.1261714.
    • 18. Ferrari N, Cattadori IM, Rizzoli A, Hudson PJ. Heligmosomoides polygyrus reduces infestation of Ixodes ricinus in free-living yellow-necked mice, Apodemus flavicollis. Parasitology. 2009;136(3):305-16. doi:10.1017/ S0031182008005404.
    • 19. Rousham EK. An increase in Giardia duodenalis infection among children receiving periodic anthelmintic treatment in Bangladesh. J Trop Pediatr. 1994;40(6):329-33.
    • 20. Jex AR, Lim YA, Bethony JM, Hotez PJ, Young ND, Gasser RB. Soil-transmitted helminths of humans in Southeast Asia-towards integrated control. Adv Parasitol. 2011;74:231-65. doi:10.1016/B978-0-12-385897-9.00004-5.
    • 21. Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012;379(9832): 2151-61. doi:10.1016/S0140-6736(12)60560-1.
    • 22. Thompson CN, Phan MV, Hoang NV, Minh PV, Vinh NT, Thuy CT, et al. A prospective multi-center observational study of children hospitalized with diarrhea in Ho Chi Minh City, Vietnam. Am J Trop Med Hyg. 2015;92(5): 1045-52. doi:10.4269/ajtmh.14-0655.
    • 23. Wang JX, Pan CS, Cui LW, Chen X. Application of a real-time PCR method for detecting and monitoring hookworm Necator americanus infections in Southern China. Asian Pacific journal of tropical biomedicine. 2012;2(12): 925-9. doi:10.1016/S2221-1691(13)60001-5.
    • 24. General Statistics Office of Viet Nam. Population and employment. 2013. http://www.gso.gov.vn/Default_en.aspx?tabid=491. Accessed 8 Mar 2016.
    • 25. Hoa NT, Huong TC, Diep LTN. Knowledge of parents and practice of children in hookworm infestation among primary pupils in Cu Chi district, HCM City. Ho Chi Minh Med Magazine. 2009;13(4):218-24.
    • 26. Hotez PJ, Brindley PJ, Bethony JM, King CH, Pearce EJ, Jacobson J. Helminth infections: the great neglected tropical diseases. J Clin Invest. 2008;118(4): 1311-21. doi:10.1172/JCI34261.
    • 27. Montresor A. Helminth control in school-age children: a guide for managers of control programmes. Geneva: World Health Organization; 2002.
    • 28. Roche M, Layrisse M. The nature and causes of “hookworm anemia.”. Am J Trop Med Hyg. 1966;15(6):1029-102.
    • 29. World Health Organization. Iron deficiency anaemia: assessment, prevention and control. A guide for programme managers. World Health Organization; 2001.
    • 30. World Health Organization. WHO model prescribing information: drugs used in parasitic diseases. Second Edition. 1995. Geneva: World Health Organization.
    • 31. Mejia R, Vicuna Y, Broncano N, Sandoval C, Vaca M, Chico M, et al. A novel, multi-parallel, real-time polymerase chain reaction approach for eight gastrointestinal parasites provides improved diagnostic capabilities to resource-limited at-risk populations. Am J Trop Med Hyg. 2013;88(6): 1041-7. doi:10.4269/ajtmh.12-0726.
    • 32. Dung TT, Phat VV, Nga TV, My PV, Duy PT, Campbell JI, et al. The validation and utility of a quantitative one-step multiplex RT real-time PCR targeting rotavirus A and norovirus. J Virol Methods. 2013;187(1):138-43. doi:10.1016/j. jviromet.2012.09.021.
    • 33. Anders KL, Thompson CN, Thuy NT, Nguyet NM, le Tu TP, Dung TT, et al. The epidemiology and aetiology of diarrhoeal disease in infancy in southern Vietnam: a birth cohort study. Int J Infect Dis. 2015;35:3-10. doi:10. 1016/j.ijid.2015.03.013.
    • 34. World Health Organization. The treatment of diarrhea: a manual for physicians and other senior health workers- 4th revision. 2005. Geneva: World Health Organization.
    • 35. Morris SS, Cousens SN, Lanata CF, Kirkwood BR. Diarrhoea-defining the episode. Int J Epidemiol. 1994;23(3):617-23.
    • 36. Isenbarger DW, Hien BT, Ha HT, Ha TT, Bodhidatta L, Pang LW, et al. Prospective study of the incidence of diarrhoea and prevalence of bacterial pathogens in a cohort of Vietnamese children along the Red River. Epidemiol Infect. 2001;127(2):229-36.
    • 37. Schloss PD, Westcott SL, Ryabin T, Hall JR, Hartmann M, Hollister EB, et al. Introducing mothur: open-source, platform-independent, communitysupported software for describing and comparing microbial communities. Appl Environ Microbiol. 2009;75(23):7537-41. doi:10.1128/AEM.01541-09.
    • 38. Segata N, Izard J, Waldron L, Gevers D, Miropolsky L, Garrett WS, et al. Metagenomic biomarker discovery and explanation. Genome Biol. 2011; 12(6):R60. doi:10.1186/gb-2011-12-6-r60.
    • 39. Trotti A, Colevas AD, Setser A, Rusch V, Jaques D, Budach V, et al. CTCAE v3. 0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 2003;13(3):176-81. doi:10.1016/ S1053-4296(03)00031-6.
    • 40. World Health Organization. Soil-transmitted helminthiases: eliminating soiltransmitted helminthiases as a public health problem in children: progress report 2001-2010 and strategic plan 2011-2020. Geneva: World Health Organization; 2012.
    • 41. Kirwan P, Jackson AL, Asaolu SO, Molloy SF, Abiona TC, Bruce MC, et al. Impact of repeated four-monthly anthelmintic treatment on Plasmodium infection in preschool children: a double-blind placebo-controlled randomized trial. BMC Infect Dis. 2010;10:277. doi:10.1186/1471-2334-10-277.
    • 42. Wiria AE, Hamid F, Wammes LJ, Kaisar MM, May L, Prasetyani MA, et al. The effect of three-monthly albendazole treatment on malarial parasitemia and allergy: a household-based cluster-randomized, double-blind, placebocontrolled trial. PLoS One. 2013;8(3), e57899. doi:10.1371/journal.pone. 0057899.
    • 43. Kepha S, Nuwaha F, Nikolay B, Gichuki P, Mwandawiro CS, Mwinzi PN, et al. Effect of repeated anthelminthic treatment on malaria in school children in Kenya: a randomized, open-label, equivalence trial. J Infect Dis. 2015. doi:10. 1093/infdis/jiv382.
    • 44. Steinmann P, Utzinger J, Du ZW, Jiang JY, Chen JX, Hattendorf J, et al. Efficacy of single-dose and triple-dose albendazole and mebendazole against soil-transmitted helminths and Taenia spp.: a randomized controlled trial. PLoS One. 2011;6(9):e25003. doi:10.1371/journal.pone.0025003.
    • 45. Jia TW, Melville S, Utzinger J, King CH, Zhou XN. Soil-transmitted helminth reinfection after drug treatment: a systematic review and meta-analysis. PLoS Negl Trop Dis. 2012;6(5), e1621. doi:10.1371/journal.pntd.0001621.
    • 46. Horton J. Albendazole: a review of anthelmintic efficacy and safety in humans. Parasitology. 2000;121(Suppl):S113-32.
    • 47. Schmidt WP, Arnold BF, Boisson S, Genser B, Luby SP, Barreto ML, et al. Epidemiological methods in diarrhoea studies-an update. Int J Epidemiol. 2011;40(6):1678-92.
    • 48. Lamberti LM, Fischer Walker CL, Black RE. Systematic review of diarrhea duration and severity in children and adults in low- and middle-income countries. BMC Public Health. 2012;12:276. doi:10.1186/1471-2458-12-276.
    • 49. McSorley HJ, Hewitson JP, Maizels RM. Immunomodulation by helminth parasites: defining mechanisms and mediators. Int J Parasitol. 2013;43(3-4): 301-10. doi:10.1016/j.ijpara.2012.11.011.
    • 50. Leung JM, Loke P. A role for IL-22 in the relationship between intestinal helminths, gut microbiota and mucosal immunity. Int J Parasitol. 2013; 43(3-4):253-7. doi:10.1016/j.ijpara.2012.10.015.
  • No similar publications.

Share - Bookmark

Funded by projects

Cite this article