ScabiesPhase 4AIM-SkinNCT02775617

Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

A Phase 4 study testing Ivermectin, Azithromycin and Permethrin in people with Scabies and Yaws, run by London School of Hygiene and Tropical Medicine at 1 site in Solomon Islands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Scabies, Yaws, Impetigo
What is being tested?: Ivermectin, Azithromycin and Permethrin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,291 participants
Where: 1 siteSolomon Islands
Study dates: Jul 2016to 5 Feb 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

All community members are able to be included in the study.

Who cannot join

Allergy to any of the components of the allocated drug regimen

Trial locations and contacts

1 site in 1 country.

Solomon Islands1 site

Atoifi Adventist Hospital
Atoifi, Malaita Province

About this study

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

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

Conditions: Scabies, Yaws, Impetigo
Being tested: Ivermectin, Azithromycin, Permethrin
Medical subject headings: Scabies, Yaws, Impetigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IvermectinDrug
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.
AzithromycinDrug
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.
PermethrinDrug
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.

Study groups in NCT02775617
Study group	Role	What they receive
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. Receives: Drug: Ivermectin; Drug: Azithromycin; Drug: Permethrin
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. Receives: Drug: Ivermectin; Drug: Azithromycin; Drug: Permethrin

What is being measured

The primary outcome is the main question the study is designed to answer.

Impetigo Prevalence at 12 Months
Change in prevalence of impetigo between baseline and 12-months
Measured: Baseline and 12 months

Secondary outcomes (2)

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
Measured: 12 Months
Antimicrobial Resistance in Culture Isolates
The proportion of samples from which a drug-resistant isolate of S.pyogenes is cultured in the two arms
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20165 Feb 2018

First posted17 May 2016 (estimated)
Study startJul 2016
Primary completionAug 2017
Study completion5 Feb 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ScabiesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,291 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02775617
Sponsor's protocol ID: 35148A
Acronym: AIM-Skin
Status last verified: Sep 2019
First submitted: 24 Feb 2016
Last updated: 17 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided: Anonymised data may be made available

Publications

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.
PubMed 29985978

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Scabies trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Combined Azithromycin and Ivermectin Mass Drug Administration for Yaws and Scabies - Impact on Impetigo and Skin Microbiology
ClinicalTrials.gov ID: NCT02775617
Acronym / sponsor ID: AIM-Skin / 35148A
Conditions: Scabies, Yaws, Impetigo
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,291 participants (actual)
Lead sponsor: London School of Hygiene and Tropical MedicineUniversity, hospital or other
Collaborators: Atoifi Adventist Hospital, Solomon Islands, Kirby Institute, Murdoch Childrens Research Institute
Study start: Jul 2016 (actual)
Primary completion: Aug 2017 (actual)
Study completion: 5 Feb 2018 (actual)
First posted: 17 May 2016 (estimated)
Results: Posted 13 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Parallel Treatment	Other	Drug: Ivermectin, Drug: Azithromycin, Drug: PermethrinSite 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	Drug: Ivermectin, Drug: Azithromycin, Drug: PermethrinSite 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

All community members are able to be included in the study.

Key exclusion criteria (1 listed)

Allergy to any of the components of the allocated drug regimen

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IvermectinParticipants 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.	Drug	Parallel Treatment, Sequential Treatment
AzithromycinParticipants 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.	Drug	Parallel Treatment, Sequential Treatment
PermethrinParticipants 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.	Drug	Parallel Treatment, Sequential Treatment

Primary outcome

Impetigo Prevalence at 12 Months
Time frame: Baseline and 12 months
Change in prevalence of impetigo between baseline and 12-months

2 secondary outcomes

Group A Streptococcus at 12 Months
Time frame: 12 Months
Antimicrobial Resistance in Culture Isolates
Time frame: 12 Months

Results and safety

Results posted to the registry on 13 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Parallel Treatment	653	605
Sequential Treatment	638	478

Primary outcome: Impetigo Prevalence at 12 Months

Time frame: Baseline and 12 months. Number. Unit: Cases of impetigo

Measure	Parallel Treatment n = 653	Sequential Treatment n = 638
Cases Impetigo at Baseline	79	66
Cases Impetigo at 12 Months	20	12

Population analysed: 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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Parallel Treatment	0 of 653 (0%)	0 of 653 (0%)	0 of 653
Sequential Treatment	0 of 638 (0%)	0 of 638 (0%)	0 of 638

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29985978Marks 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.
Individual participant dataSharing planned: Undecided. Anonymised data may be made available

Related trials for Scabies

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Marks principal investigator

London School of Hygiene and Tropical Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ivermectin, Azithromycin and Permethrin in people with Scabies and Yaws, run by London School of Hygiene and Tropical Medicine at 1 site in Solomon Islands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Solomon Islands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impetigo Prevalence at 12 Months (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775617, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.