The Impact of Anthelmintic Treatment on the Incidence of Diarrheal Disease in Vietnamese School Children
NCT ID: NCT02597556
Last Updated: 2016-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-02-29
2016-05-31
Brief Summary
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This study will recruit 350 helminth-infected and 350 helminth-uninfected children aged 6-15 years. Recruited children will be randomized to receive either anthelmintic or placebo treatment once every three months and will be monitored for incidences of diarrheal disease for 12 months. At the 12-month time point, all children will receive anthelmintic treatment. Blood and stool samples will be collected throughout the study and used for evaluation of anemia and host immune responses, and for classification of gut microbes and parasite detection, respectively. The interventional study proposed here will provide an important first test of whether anthelmintic treatments have any indirect effects on infections caused by diarrheal pathogens.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Albendazole
Albendazole will be administered as a single 400mg chewable tablet at 0, 3, 6, 9, and 12 months.
Albendazole
A single 400mg dose of Albendazole administered at 0, 3, 6, 9, and 12 months.
Placebo
Matching Placebo will be administered as a single chewable tablet at 0, 3, 6, and 9 months. At month 12, all participants will receive a single 400mg Albendazole tablet.
Placebo
Matching placebo tablet administered at 0, 3, 6, and 9 months. At month 12, all participants will receive a single dose of 400mg Albendazole.
Interventions
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Albendazole
A single 400mg dose of Albendazole administered at 0, 3, 6, 9, and 12 months.
Placebo
Matching placebo tablet administered at 0, 3, 6, and 9 months. At month 12, all participants will receive a single dose of 400mg Albendazole.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent from a parent or guardian
* Written assent from children \>10 years of age
* Subjects that are both hookworm-positive and anemic, as defined by the WHO guidelines
6 Years
15 Years
ALL
Yes
Sponsors
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Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
OTHER
Ho Chi Minh Preventive Medicine Centre, Vietnam
UNKNOWN
Princeton University
OTHER
Cu Chi Health Department
UNKNOWN
Oxford University Clinical Research Unit, Vietnam
OTHER
Responsible Party
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Principal Investigators
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Stephen Baker, PhD
Role: PRINCIPAL_INVESTIGATOR
Oxford University Clinical Research Unit
Nghia Ho Dang Trung, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Pham Ngoc Thach University of Medicine
Andrea Graham, PhD
Role: PRINCIPAL_INVESTIGATOR
Princeton University, USA
Jacqueline Leung, MA
Role: STUDY_DIRECTOR
Princeton University, USA
Locations
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Cu Chi, Viet Nam
Ho Chi Minh City, , Vietnam
Countries
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References
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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. Proc Biol Sci. 2013 Aug 28;280(1769):20131671. doi: 10.1098/rspb.2013.1671. Print 2013 Oct 22.
Ezenwa VO, Jolles AE. Epidemiology. Opposite effects of anthelmintic treatment on microbial infection at individual versus population scales. Science. 2015 Jan 9;347(6218):175-7. doi: 10.1126/science.1261714.
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 Mar;136(3):305-16. doi: 10.1017/S0031182008005404. Epub 2009 Jan 21.
Knowles SC, Fenton A, Petchey OL, Jones TR, Barber R, Pedersen AB. Stability of within-host-parasite communities in a wild mammal system. Proc Biol Sci. 2013 May 15;280(1762):20130598. doi: 10.1098/rspb.2013.0598. Print 2013 Jul 7.
Pedersen AB, Antonovics J. Anthelmintic treatment alters the parasite community in a wild mouse host. Biol Lett. 2013 May 8;9(4):20130205. doi: 10.1098/rsbl.2013.0205. Print 2013 Aug 23.
Nacher M. Worms and malaria: resisting the temptation to generalize. Trends Parasitol. 2006 Aug;22(8):350-1; author reply 351-2. doi: 10.1016/j.pt.2006.06.003. Epub 2006 Jun 23. No abstract available.
Rousham EK. An increase in Giardia duodenalis infection among children receiving periodic Anthelmintic treatment in Bangladesh. J Trop Pediatr. 1994 Dec;40(6):329-33. doi: 10.1093/tropej/40.6.329.
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. Cochrane Database Syst Rev. 2015 Jul 23;2015(7):CD000371. doi: 10.1002/14651858.CD000371.pub6.
Leung JM, Hong CT, Trung NH, Thi HN, Minh CN, Thi TV, Hong DT, Man DN, Knowles SC, Wolbers M, Hoang Nle T, Thwaites G, Graham AL, Baker S. The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trial. Trials. 2016 Jun 6;17(1):279. doi: 10.1186/s13063-016-1406-1.
Related Links
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Oxford University Clinical research Unit
Other Identifiers
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16EN
Identifier Type: -
Identifier Source: org_study_id