Clinical Trial: Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Impact of Combined Azithromycin and Ivermectin Mass Drug Administration for Yaws and Scabies - Impact on Impetigo and Skin Microbiology

Brief Summary:

This is an open-label prospective community intervention trial to assess the impact of community mass treatment with azithromycin for yaws and ivermectin for scabies, on non-yaws bacterial skin infections.

Communities will be randomised to receive standard treatment for both yaws and scabies either in parallel (site 1) or in sequence (site 2).

Treatment of yaws:

Single dose of Azithromycin (30mg/kg, max 2G).

Treatment of scabies:

Either an oral dose of Ivermectin (200μg/kg) or permethrin cream for those with a contraindication to Ivermectin (WT<15kg, pregnant or breastfeeding women) given in 2 doses 7-14 days apart.

Investigators will complete a clinical and microbiological assessment of bacterial skin disease at baseline and at 12 months to assess the impact of treatment on the prevalence of bacterial infection and the emergence of antimicrobial resistance.

Primary Outcome

  1. Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms.

    Secondary Outcomes

  2. Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
  3. The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms

Detailed Summary:
Sponsor: London School of Hygiene and Tropical Medicine

Current Primary Outcome: Change in Impetigo Prevalence at 12 Months [ Time Frame: Baseline and 12 months ]

Difference in the change in prevalence of impetigo between baseline and 12-months between the parallel and the sequential treatment arms.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Culture Proven Group A Streptococcus at 12 Months [ Time Frame: 12 Months ]
    Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
  • Antimicrobial Resistance in Culture Isolates [ Time Frame: 12 Months ]
    The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms


Original Secondary Outcome:

  • Change in Prevalence of Culture Proven Group A Streptococcus at 12 Months [ Time Frame: Baseline and 12 Months ]
    Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
  • Difference in Proportion of Antimicrobial Resistance in Culture Isolates at 12 Months [ Time Frame: Baseline and 12 Months ]
    The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms


Information By: London School of Hygiene and Tropical Medicine

Dates:
Date Received: February 24, 2016
Date Started: July 2016
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016