A cluster randomized study of the safety of integrated treatment of trachoma and lymphatic filariasis in children and adults in Sikasso, Mali

• Published in: PLoS neglected tropical diseases 2013-05, Vol.7 (5), p.e2221
• Main Authors: Coulibaly, Yaya Ibrahim, Dicko, Ilo, Keita, Modibo, Keita, Mahamadou Minamba, Doumbia, Moussa, Daou, Adama, Haidara, Fadima Cheick, Sankare, Moussa Hama, Horton, John, Whately-Smith, Caroline, Sow, Samba Ousmane
• Format: Article
• Language: English
• Subjects: Abdomen; Adolescent; Adult; Aged; Albendazole - adverse effects; Albendazole - therapeutic use; Anthelmintics - adverse effects; Anthelmintics - therapeutic use; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Azithromycin - adverse effects; Azithromycin - therapeutic use; Care and treatment; Chemoprevention - adverse effects; Chemoprevention - methods; Chemotherapy; Child; Child, Preschool; Children; Clinical trials; Coinfection - drug therapy; Coinfection - prevention & control; Demographic aspects; Diagnosis; Drug therapy; Drug Therapy, Combination - adverse effects; Drug Therapy, Combination - methods; Drug-Related Side Effects and Adverse Reactions - epidemiology; Drug-Related Side Effects and Adverse Reactions - pathology; Elephantiasis, Filarial - drug therapy; Elephantiasis, Filarial - prevention & control; Female; Filariasis; Health aspects; Health care; Humans; Infections; Ivermectin - adverse effects; Ivermectin - therapeutic use; Male; Mali; Medicine; Middle Aged; Neglected Diseases - drug therapy; Neglected Diseases - prevention & control; Pain; Towns; Trachoma; Trachoma - drug therapy; Trachoma - prevention & control; Tropical diseases; Young Adult
• ISSN: 1935-2735; 1935-2727; 1935-2735
• DOI: 10.1371/journal.pntd.0002221

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. 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. 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. ClinicalTrials.gov; NCT01586169.