title: A cluster randomized study of the safety of integrated treatment of trachoma and lymphatic filariasis in children and adults in Sikasso, Mali.
abstract: 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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov; NCT01586169.
authors.affiliation: Centre National d'Appui à la Lutte contre la Maladie, Bamako, Mali.
authors.forename: Yaya Ibrahim
authors.initials: YI
authors.lastname: Coulibaly
authors.forename: Ilo
authors.initials: I
authors.lastname: Dicko
authors.forename: Modibo
authors.initials: M
authors.lastname: Keita
authors.forename: Mahamadou Minamba
authors.initials: MM
authors.lastname: Keita
authors.forename: Moussa
authors.initials: M
authors.lastname: Doumbia
authors.forename: Adama
authors.initials: A
authors.lastname: Daou
authors.forename: Fadima Cheick
authors.initials: FC
authors.lastname: Haidara
authors.forename: Moussa Hama
authors.initials: MH
authors.lastname: Sankare
authors.forename: John
authors.initials: J
authors.lastname: Horton
authors.forename: Caroline
authors.initials: C
authors.lastname: Whately-Smith
authors.forename: Samba Ousmane
authors.initials: SO
authors.lastname: Sow
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015766:Albendazole / Q000009:adverse effects / Q000627:therapeutic use; D000871:Anthelmintics / Q000009:adverse effects* / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D017963:Azithromycin / Q000009:adverse effects / Q000627:therapeutic use; D018890:Chemoprevention / Q000009:adverse effects / Q000379:methods; D002648:Child; D002675:Child, Preschool; D060085:Coinfection / Q000188:drug therapy / Q000517:prevention & control; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004605:Elephantiasis, Filarial / Q000188:drug therapy* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007559:Ivermectin / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008302:Mali; D008875:Middle Aged; D058069:Neglected Diseases / Q000188:drug therapy / Q000517:prevention & control; D014141:Trachoma / Q000188:drug therapy* / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000871:Anthelmintics; D000900:Anti-Bacterial Agents; D007559:Ivermectin; D017963:Azithromycin; D015766:Albendazole