Impetigo, Scabies, Yaws
Conditions
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
Interventions
DRUGIvermectin
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.
DRUGAzithromycin
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.
DRUGPermethrin
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.
Sponsors
Atoifi Adventist Hospital, Solomon Islands
Kirby Institute
Murdoch Childrens Research Institute
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All community members are able to be included in the study.
Exclusion criteria
* Allergy to any of the components of the allocated drug regimen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impetigo Prevalence at 12 Months | Baseline and 12 months | Change in prevalence of impetigo between baseline and 12-months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group A Streptococcus at 12 Months | 12 Months | Change in the percentage of swab samples from which S. pyogenes is cultured between baseline and 12 month follow-up in the two arms |
| Antimicrobial Resistance in Culture Isolates | 12 Months | The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms |
Countries
Solomon Islands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 653 |
| 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. | 638 |
| Total | 1,291 |
Baseline characteristics
| Characteristic | Parallel Treatment | Total | Sequential Treatment |
|---|---|---|---|
| Age, Continuous | 24 years | 25 years | 25 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 653 Participants | 1291 Participants | 638 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Solomon Islands | 653 participants | 1291 participants | 638 participants |
| Sex: Female, Male Female | 335 Participants | 647 Participants | 312 Participants |
| Sex: Female, Male Male | 318 Participants | 644 Participants | 326 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 653 | 0 / 638 |
| other Total, other adverse events | 0 / 653 | 0 / 638 |
| serious Total, serious adverse events | 0 / 653 | 0 / 638 |
Outcome results
Primary
Impetigo Prevalence at 12 Months
Change in prevalence of impetigo between baseline and 12-months
Time frame: Baseline and 12 months
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parallel Treatment | Impetigo Prevalence at 12 Months | Cases Impetigo at Baseline | 79 Cases of impetigo |
| Parallel Treatment | Impetigo Prevalence at 12 Months | Cases Impetigo at 12 Months | 20 Cases of impetigo |
| Sequential Treatment | Impetigo Prevalence at 12 Months | Cases Impetigo at Baseline | 66 Cases of impetigo |
| Sequential Treatment | Impetigo Prevalence at 12 Months | Cases Impetigo at 12 Months | 12 Cases of impetigo |
Secondary
Antimicrobial Resistance in Culture Isolates
The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
Time frame: 12 Months
Population: This analysis was restricted to the subset of patients in whom S.pyogenes was isolated on a swab
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parallel Treatment | Antimicrobial Resistance in Culture Isolates | % Swabs with resistance at baseline | 0 Number of swabs |
| Parallel Treatment | Antimicrobial Resistance in Culture Isolates | % Swabs with resistance at 12 months | 0 Number of swabs |
| Sequential Treatment | Antimicrobial Resistance in Culture Isolates | % Swabs with resistance at baseline | 0 Number of swabs |
| Sequential Treatment | Antimicrobial Resistance in Culture Isolates | % Swabs with resistance at 12 months | 0 Number of swabs |
Secondary
Group A Streptococcus at 12 Months
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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Parallel Treatment | Group A Streptococcus at 12 Months | Swabs containing S.pyogenes at baseline | 17 Change in number swabs with S.pyogenes |
| Parallel Treatment | Group A Streptococcus at 12 Months | Swabs containing S.pyogenes at 12 months | 4 Change in number swabs with S.pyogenes |
| Sequential Treatment | Group A Streptococcus at 12 Months | Swabs containing S.pyogenes at 12 months | 1 Change in number swabs with S.pyogenes |
| Sequential Treatment | Group A Streptococcus at 12 Months | Swabs containing S.pyogenes at baseline | 28 Change in number swabs with S.pyogenes |