Feasibility and safety of mass drug coadministration with azithromycin and ivermectin for the control of neglected tropical diseases: A single-arm intervention trial
The Lancet Global Health Sep 20, 2018
Romani L, et al. - In the largest trial so far, researchers studied the impact of mass drug administration in the Solomon Islands for controlling trachoma and scabies using ivermectin and azithromycin, which are crucial drugs in controlling neglected tropical diseases worldwide. In a population of more than 26,000 people, the coadministration of regimens based on ivermectin and azithromycin was demonstrated to be safe and feasible. Coadministration of mass drug administration based on these two drugs creates new potential for the control of these types of diseases.
Methods
- For trachoma elimination, researchers administered an azithromycin-based mass drug administration regimen in line with standard recommendations (oral azithromycin or topical tetracycline).
- At the same time, they offered an ivermectin-based mass drug administration regimen (oral ivermectin or topical permethrin), with a further dose 7–14 days later, using a modified version of a regimen demonstrated to be effective for scabies control.
- They performed safety assessments on all participants 7–14 days later.
- A more detailed safety assessment was performed on participants in ten randomly selected sentinel villages.
- Before and after the mass drug administration, they also obtained routine health system reports of hospital or clinic admissions and deaths to compare health outcomes in the 12-month period.
Results
- Researchers enrolled 26,188 participants in this study, which was 99.3% of the estimated resident population as determined at the 2009 census.
- Trachoma regimen was provided to 25,717 (98.2%) and the first dose of the scabies regimen was administered to 25,819 (98.6%) between September 1, and October 2, 2015.
- In this study, 21,931 (83.7%) participants received a second dose of the scabies regimen.
- In 571 (2.6%) of the entire study population and 58 (4.1%) of participants in the ten sentinel villages, mild and transient adverse events were recorded.
- The numbers of hospital admissions (1,530 vs 1,602) and deaths (73 vs 83) were similar in the 12 months before and after the mass drug administration.
- In the month after the mass drug administration, they reported admission of 84 individuals to hospital and two deaths, compared with a monthly median of 116 admissions (IQR 106–159) and six deaths (IQR 4–7) in the 12 months before and after the mass drug administration.
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