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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A Cluster Randomized Study of The Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults in Sikasso, Mali
PLoS Neglected Tropical Diseases, Volume 7, No. 5, Article e2221, Year 2013
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Description
Background: Neglected tropical diseases are co-endemic in many areas of the world, including sub Saharan Africa. Currently lymphatic filariasis (albendazole/ivermectin) and trachoma (azithromycin) are treated separately. Consequently, financial and logistical benefit can be gained from integration of preventive chemotherapy programs in such areas. Methodology/Findings: 4 villages in two co-endemic districts (Kolondièba and Bougouni) of Sikasso, Mali, were randomly assigned to coadministered treatment (ivermectin/albendazole/azithromycin) or standard therapy (ivermectin/albendazole with azithromycin 1 week later). These villages had previously undergone 4 annual MDA campaigns with ivermectin/albendazole and 2 with azithromycin. One village was randomly assigned to each treatment arm in each district. There were 7515 eligible individuals in the 4 villages, 3011(40.1%) of whom participated in the study. No serious adverse events occurred, and the majority of adverse events were mild in intensity (mainly headache, abdominal pain, diarrhoea and "other signs/symptoms"). The median time to the onset of the first event, of any type, was later (8 days) in the two standard treatment villages than in the co-administration villages. Overall the number of subjects reporting any event was similar in the co-administration group compared to the standard treatment group [18.7% (281/1501) vs. 15.8% (239/1510)]. However, the event frequency was higher in the coadministration group (30.4%) than in the standard treatment group (11.0%) in Kolondièba, while the opposite was observed in Bougouni (7.1% and 20.9% respectively). Additionally, the overall frequency of adverse events in the co-administration group (18.7%) was comparable to or lower than published frequencies for ivermectin+albendazole alone. Conclusions: These data suggest that co-administration of ivermectin+albendazole and azithromycin is safe; however the small number of villages studied and the large differences between them resulted in an inability to calculate a meaningful overall estimate of the difference in adverse event rates between the regimens. Further work is therefore needed before co-administration can be definitively recommended. Trial Registration: ClinicalTrials.gov; NCT01586169. © 2013 Coulibaly et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3649960/bin/pntd.0002221.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3649960/bin/pntd.0002221.s002.tif
https://efashare.b-cdn.net/share/pmc/articles/PMC3649960/bin/pntd.0002221.s003.tiff
https://efashare.b-cdn.net/share/pmc/articles/PMC3649960/bin/pntd.0002221.s004.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC3649960/bin/pntd.0002221.s005.pdf
Authors & Co-Authors
Coulibaly, Youssouf
Mali, Bamako
Centre National D'appui à la Lutte Contre la Maladie
Mali
Faculty of Medicine of Bamako
Dicko, Ilo O.
Mali
Faculty of Medicine of Bamako
Keita, Modibo T.
Mali, Bamako
Centre National D'appui à la Lutte Contre la Maladie
Keita, Mahamadou Minamba
Mali, Bamako
Centre National D'appui à la Lutte Contre la Maladie
Doumbia, Moussa F.
Mali, Bamako
Centre National D'appui à la Lutte Contre la Maladie
Daou, Adama
Mali, Bamako
Centre National D'appui à la Lutte Contre la Maladie
Haidara, Fadima Cheick
Mali, Bamako
Centre National D'appui à la Lutte Contre la Maladie
Sankare, Moussa Hama
Mali, Bamako
Direction Nationale de la Santé
Horton, John
United Kingdom, Hitchin
Tropical Projects
Whately-Smith, Caroline
United Kingdom, Kings Langley
Whately-smith Limited
Sow, Samba Ousmane
Mali, Bamako
Centre National D'appui à la Lutte Contre la Maladie
Statistics
Citations: 26
Authors: 11
Affiliations: 5
Identifiers
Doi:
10.1371/journal.pntd.0002221
ISSN:
19352727
e-ISSN:
19352735
Research Areas
Cancer
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Mali