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

Details

• Alternative Title:
  PLoS Negl Trop Dis
• Personal Author:
  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
• Description:
  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.
  
  Methodology/Findings
  
  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.
  
  Trial Registration
  
  ClinicalTrials.gov; NCT01586169
  
  
• Subjects:
  Adolescent Adult Aged Albendazole Anthelmintics Anti-Bacterial Agents Azithromycin Chemoprevention Child Child, Preschool Coinfection Drug-Related Side Effects And Adverse Reactions Drug Therapy, Combination Elephantiasis, Filarial Female Humans Ivermectin Male Mali Middle Aged Neglected Diseases Trachoma Young Adult

  More +
• Source:
  PLoS Negl Trop Dis. 2013; 7(5).
• Document Type:
  Journal Article
• Volume:
  7
• Issue:
  5
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:d4f158ec9ea2b0efc8719f0fb70b49ef522ac34feeac83160b02cdfee0294a2c
• Download URL:
  https://stacks.cdc.gov/view/cdc/13451/cdc_13451_DS1.pdf
• File Type:
  [PDF - 532.56 KB ]