A Cluster Randomized Study of the Safety of Integrated Treatment of Trachoma and Lymphatic Filariasis in Children and Adults in Sikasso,Mali

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.