TY - JOUR
T1 - The impact of albendazole treatment on the incidence of viral- and bacterialinduced diarrhea in school children in southern Vietnam
T2 - Study protocol for a randomized controlled trial
AU - Leung, Jacqueline M.
AU - Hong, Chau Tran Thi
AU - Trung, Nghia Ho Dang
AU - Thi, Hoa Nhu
AU - Minh, Chau Nguyen Ngoc
AU - Thi, Thuy Vu
AU - Hong, Dinh Thanh
AU - Man, Dinh Nguyen Huy
AU - Knowles, Sarah C.L.
AU - Wolbers, Marcel
AU - Hoang, Nhat Le Thanh
AU - Thwaites, Guy
AU - Graham, Andrea Linn
AU - Baker, Stephen
N1 - Funding Information:
Oxford University is the study sponsor and holds the necessary insurance for the trial. This study is supported by the Grand Challenges in Health Program at Princeton University (ALG, SB, and JML), a National Science Foundation Doctoral Dissertation Improvement Grant (JML and ALG), and the Lewis and Clark Fund for Exploration and Field Research (JML). JML is supported by a National Science Foundation Graduate Research Fellowship, and SB is a Sir Henry Dale fellow, supported by the Wellcome Trust and the Royal Society, UK. The sponsors and funders had no role in the design of this study and will not have any role during its execution, analyses, or decision to submit results.
Publisher Copyright:
© 2016 Leung et al.
PY - 2016
Y1 - 2016
N2 - 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.
AB - 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.
KW - Albendazole
KW - Co-infection
KW - Deworming
KW - Diarrhea
KW - Soil-transmitted helminths
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UR - http://www.scopus.com/inward/citedby.url?scp=85007470677&partnerID=8YFLogxK
U2 - 10.1186/S13063-016-1406-1
DO - 10.1186/S13063-016-1406-1
M3 - Article
C2 - 27266697
AN - SCOPUS:85007470677
SN - 1745-6215
VL - 17
JO - Trials
JF - Trials
IS - 1
M1 - 279
ER -