Trial Outcomes & Findings for Azithromycin - Ivermectin Mass Drug Administration for Skin Disease (NCT NCT02775617)
NCT ID: NCT02775617
Last Updated: 2019-09-17
Results Overview
Change in prevalence of impetigo between baseline and 12-months
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1291 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2019-09-17
Participant Flow
Participant milestones
| Measure |
Parallel Treatment
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
Sequential Treatment
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
|---|---|---|
|
Overall Study
STARTED
|
653
|
638
|
|
Overall Study
COMPLETED
|
605
|
478
|
|
Overall Study
NOT COMPLETED
|
48
|
160
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Azithromycin - Ivermectin Mass Drug Administration for Skin Disease
Baseline characteristics by cohort
| Measure |
Parallel Treatment
n=653 Participants
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
Sequential Treatment
n=638 Participants
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
Total
n=1291 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
335 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
647 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
318 Participants
n=5 Participants
|
326 Participants
n=7 Participants
|
644 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
653 Participants
n=5 Participants
|
638 Participants
n=7 Participants
|
1291 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Solomon Islands
|
653 participants
n=5 Participants
|
638 participants
n=7 Participants
|
1291 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: At the baseline survey 653 individuals were seen in the Parallel arm and 638 in the sequential treatment arm. At the 12 month survey 605 individuals were seen in the Parallel arm and 478 in the sequential treatment arm
Change in prevalence of impetigo between baseline and 12-months
Outcome measures
| Measure |
Parallel Treatment
n=653 Participants
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
Sequential Treatment
n=638 Participants
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
|---|---|---|
|
Impetigo Prevalence at 12 Months
Cases Impetigo at Baseline
|
79 Cases of impetigo
|
66 Cases of impetigo
|
|
Impetigo Prevalence at 12 Months
Cases Impetigo at 12 Months
|
20 Cases of impetigo
|
12 Cases of impetigo
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Samples were collected at twelve months from individuals with clinical impetigo and cultured for both pyogenic streptococci and S.aureus. This analysis is therefore restricted to the subset of patients who had impetigo from which a swab was collected
Change in the percentage of swab samples from which S. pyogenes is cultured between baseline and 12 month follow-up in the two arms
Outcome measures
| Measure |
Parallel Treatment
n=54 Participants
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
Sequential Treatment
n=41 Participants
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
|---|---|---|
|
Group A Streptococcus at 12 Months
Swabs containing S.pyogenes at baseline
|
17 Change in number swabs with S.pyogenes
|
28 Change in number swabs with S.pyogenes
|
|
Group A Streptococcus at 12 Months
Swabs containing S.pyogenes at 12 months
|
4 Change in number swabs with S.pyogenes
|
1 Change in number swabs with S.pyogenes
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: This analysis was restricted to the subset of patients in whom S.pyogenes was isolated on a swab
The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
Outcome measures
| Measure |
Parallel Treatment
n=33 Participants
Site 1- Parallel Treatment Arm Single dose azithromycin (for yaws) and Ivermectin/Permethrin (for scabies) will be offered on D1. A second dose of Ivermectin/Permethrin will be offered 7-14 days later.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
Sequential Treatment
n=34 Participants
Site 2- Serial Treatment Arm Ivermectin/Permethrin (for scabies) will be offered on D1 with a second dose of Ivermectin/Permethrin offered 7-14 days later..
Single dose azithromycin (for yaws) will be offered at the twelve month follow-up visit.
Ivermectin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
Azithromycin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
Permethrin: Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
|
|---|---|---|
|
Antimicrobial Resistance in Culture Isolates
% Swabs with resistance at baseline
|
0 Number of swabs
|
0 Number of swabs
|
|
Antimicrobial Resistance in Culture Isolates
% Swabs with resistance at 12 months
|
0 Number of swabs
|
0 Number of swabs
|
Adverse Events
Parallel Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sequential Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Michael Marks
London School of Hygiene and Tropical Medicine
Phone: 02079272566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place