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| Name | Class |
|---|---|
| Atoifi Adventist Hospital, Solomon Islands | UNKNOWN |
| Kirby Institute | OTHER_GOV |
| Murdoch Childrens Research Institute | OTHER |
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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
Difference in the change in prevalence of impetigo between baseline and 12- months between the parallel and the sequential treatment arms.
Secondary Outcomes
Change in the proportion of swab samples from which S. pyogenes is cultured between baseline and follow-up in the two arms
The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parallel Treatment | Other | 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. |
|
| Sequential Treatment | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Impetigo Prevalence at 12 Months | Change in prevalence of impetigo between baseline and 12-months | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 Months |
| Antimicrobial Resistance in Culture Isolates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Marks | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atoifi Adventist Hospital | Atoifi | Malaita Province | Solomon Islands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29985978 | Derived | Marks M, Toloka H, Baker C, Kositz C, Asugeni J, Puiahi E, Asugeni R, Azzopardi K, Diau J, Kaldor JM, Romani L, Redman-MacLaren M, MacLaren D, Solomon AW, Mabey DCW, Steer AC. Randomized Trial of Community Treatment With Azithromycin and Ivermectin Mass Drug Administration for Control of Scabies and Impetigo. Clin Infect Dis. 2019 Mar 5;68(6):927-933. doi: 10.1093/cid/ciy574. |
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Anonymised data may be made available
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Impetigo Prevalence at 12 Months | Change in prevalence of impetigo between baseline and 12-months | 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 | Posted | Number | Cases of impetigo | Baseline and 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michael Marks | London School of Hygiene and Tropical Medicine | 02079272566 | michael.marks@lshtm.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2016 | Nov 7, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012532 | Scabies |
| D015001 | Yaws |
| D007169 | Impetigo |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| D017963 | Azithromycin |
| D026023 | Permethrin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Azithromycin | Drug | 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 | Drug | 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. |
|
The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
| 12 Months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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 | 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 | Posted | Number | Change in number swabs with S.pyogenes | 12 Months |
|
|
|
| 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 | This analysis was restricted to the subset of patients in whom S.pyogenes was isolated on a swab | Posted | Number | Number of swabs | 12 Months |
|
|
|
| 0 |
| 653 |
| 0 |
| 653 |
| 0 |
| 653 |
| EG001 | 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. | 0 | 638 | 0 | 638 | 0 | 638 |
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| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D017192 | Skin Diseases, Bacterial |
| D013207 | Staphylococcal Skin Infections |
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D013290 | Streptococcal Infections |
| D004917 |
| Erythromycin |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011722 | Pyrethrins |
| D000081004 | Cyclopentane Monoterpenes |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| Swabs containing S.pyogenes at 12 months |
|
|
| % Swabs with resistance at 12 months |
|
|