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

Abstract

BackgroundNeglected 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/Findings4 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.ConclusionsThese 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 RegistrationClinicalTrials.gov; NCT01586169

Community seroprevalence survey for yaws and trachoma in the Western Division of Fiji

“…There is also scope for cooperation between mass treatment programs, for example co-administration of ivermectin, albendazole and azithromycin, where more than one treatment is indicated and appropriate safety and efficacy data exist. 26 Our data add to existing data suggesting that yaws is no longer a public health problem in Fiji and that trachoma is not likely to be one of the major causes of blindness in Fiji. Given the mixed findings of trachoma surveys conducted in Fiji early impact assessments should be conducted to guide Ministry of Health trachoma elimination activities.…”

Mass Drug Administration for Trachoma: How Long Is Not Long Enough?

“…They may consider alternatives such as targeted treatment [ 47 ] or biannual treatment [ 8 , 48 ]. There may be substantial cost savings associated with proposed integration of efforts to survey and distribute treatment with programs for other NTDs [ 49 – 51 ]. Most importantly, we must recognize that in the imperfect context in which programs on the ground operate, adding more annual MDAs without regard to coverage, programmatic continuity, and underlying environmental context will not guarantee trachoma elimination.…”

The public health control of scabies: priorities for research and action

“…In addition to the long-standing practice of co-administration with albendazole, large-scale studies have now demonstrated the safety of co-administration with azithromycin, opening the possibility of integrating control of scabies with control of yaws and/or trachoma. [128][129][130] Similarly, early analysis of a multi-national safety cohort study of combination therapy of ivermectin, diethylcarbamazine and albendazole (IDA) for lymphatic filariasis did not reveal safety concerns and administration of this combination of agents has now been recommended for specific epidemiological contexts within WHO guidelines. [131][132][133][134] Monitoring for development of resistance of mites to acaricides will also be important.…”