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Trial record 43 of 103 for:    IVERMECTIN

Azithromycin - Ivermectin Mass Drug Administration for Skin Disease (AIM-Skin)

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ClinicalTrials.gov Identifier: NCT02775617
Recruitment Status : Completed
First Posted : May 17, 2016
Results First Posted : September 13, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborators:
Atoifi Adventist Hospital, Solomon Islands
Kirby Institute
Murdoch Childrens Research Institute
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Scabies
Yaws
Impetigo
Interventions Drug: Ivermectin
Drug: Azithromycin
Drug: Permethrin
Enrollment 1291
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Parallel Treatment Sequential Treatment
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 653 [1] 638 [2]
Completed 605 [3] 478 [4]
Not Completed 48 160
[1]
Participants are seen at via a survey of the community. 92.6% of the resident population
[2]
Participants are seen at via a survey of the community. 88.9% of the resident population
[3]
Participants are seen at via a survey of the community. 96.3% of the resident population
[4]
Participants are seen at via a survey of the community. 76.2% of the resident population
Arm/Group Title Parallel Treatment Sequential Treatment Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 653 638 1291
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 653 participants 638 participants 1291 participants
24
(10 to 45)
25
(12 to 47)
25
(10 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 653 participants 638 participants 1291 participants
Female
335
  51.3%
312
  48.9%
647
  50.1%
Male
318
  48.7%
326
  51.1%
644
  49.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 653 participants 638 participants 1291 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
653
 100.0%
638
 100.0%
1291
 100.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Solomon Islands Number Analyzed 653 participants 638 participants 1291 participants
653 638 1291
1.Primary Outcome
Title Impetigo Prevalence at 12 Months
Hide Description Change in prevalence of impetigo between baseline and 12-months
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title Parallel Treatment Sequential Treatment
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 653 638
Measure Type: Number
Unit of Measure: Cases of impetigo
Cases Impetigo at Baseline Number Analyzed 653 participants 638 participants
79 66
Cases Impetigo at 12 Months Number Analyzed 605 participants 478 participants
20 12
2.Secondary Outcome
Title Group A Streptococcus at 12 Months
Hide Description Change in the percentage of swab samples from which S. pyogenes is cultured between baseline and 12 month follow-up in the two arms
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description

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

Arm/Group Title Parallel Treatment Sequential Treatment
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 54 41
Measure Type: Number
Unit of Measure: Change in number swabs with S.pyogenes
Swabs containing S.pyogenes at baseline Number Analyzed 38 participants 35 participants
17 28
Swabs containing S.pyogenes at 12 months Number Analyzed 16 participants 6 participants
4 1
3.Secondary Outcome
Title Antimicrobial Resistance in Culture Isolates
Hide Description The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was restricted to the subset of patients in whom S.pyogenes was isolated on a swab
Arm/Group Title Parallel Treatment Sequential Treatment
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 33 34
Measure Type: Number
Unit of Measure: Number of swabs
% Swabs with resistance at baseline Number Analyzed 17 participants 28 participants
0 0
% Swabs with resistance at 12 months Number Analyzed 16 participants 6 participants
0 0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Parallel Treatment Sequential Treatment
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Parallel Treatment Sequential Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/653 (0.00%)   0/638 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Parallel Treatment Sequential Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/653 (0.00%)   0/638 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Parallel Treatment Sequential Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/653 (0.00%)   0/638 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Michael Marks
Organization: London School of Hygiene and Tropical Medicine
Phone: 02079272566
EMail: michael.marks@lshtm.ac.uk
Layout table for additonal information
Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02775617     History of Changes
Other Study ID Numbers: 35148A
First Submitted: February 24, 2016
First Posted: May 17, 2016
Results First Submitted: November 8, 2018
Results First Posted: September 13, 2019
Last Update Posted: September 17, 2019