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

<div><p>Background</p><p>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.</p> <p>Methodology/Findings</p><p>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.</p> <p>Conclusions</p><p>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.</p> <p>Trial Registration</p><p>ClinicalTrials.gov; <a href="http://clinicaltrials.gov/ct2/show/NCT01586169" target="_blank">NCT01586169</a></p> </div

Prevalence of trachoma in the Kayes region of Mali eight years after stopping mass drug administration

<div><p>Background</p><p>In 2009, three years after stopping mass treatment with azithromycin, a trachoma impact survey in four health districts in the Kayes region of Mali found a prevalence of trachomatous inflammation—follicular (TF) among children aged 1 to 9 years of >5% and a trachomatous trichiasis (TT) prevalence within the general population (≥1-year-old) of <1%. As a result, the government’s national trachoma program expanded trichiasis surgery and related activities required to achieve trachoma elimination.</p><p>Methodology/Principal findings</p><p>In 2015, to assess progress towards elimination, a follow-up impact survey was conducted in the Kayes, Kéniéba, Nioro and Yélimané health districts. The survey used district level two-stage cluster random sampling methodology with 20 clusters of 30 households in each evaluation unit. Subjects were eligible for examination if they were ≥1 year. TF and TT cases were identified and confirmed by experienced ophthalmologists. In total 14,159 people were enumerated and 11,620 (82%) were examined. TF prevalence (95% confidence interval (CI)) was 0.5% (0.3–1%) in Kayes, 0.8% (0.4–1.7%) in Kéniéba, 0.2% (0–0.9%) in Nioro and 0.3% (0.1–1%) in Yélimané. TT prevalence (95% CI) was 0.04% (0–0.25%) in Kayes, 0.29% (0.11–0.6%) in Kéniéba, 0.04% (0–0.25%) in Nioro and 0.07% (0–0.27%) in Yélimané.</p><p>Conclusions/Significance</p><p>Eight years after stopping MDA and intensifying trichiasis surgery outreach campaigns, all four districts reached the TF elimination threshold of <5% and three of four districts reached the TT elimination threshold of <0.1%.</p></div

Comparison of trachoma TF and TT prevalence between 2009 and 2015.

<p>Comparison of trachoma TF and TT prevalence between 2009 and 2015.</p

Prevalence of active trachoma (TF) and trichiasis (TT) in four districts in Kayes region in 2015.

<p>Prevalence of active trachoma (TF) and trichiasis (TT) in four districts in Kayes region in 2015.</p

Clean faces and access to latrines and water sources in the surveyed clusters in Kayes region in 2015.

<p>Clean faces and access to latrines and water sources in the surveyed clusters in Kayes region in 2015.</p