TrachomaASANTENCT01767506
A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
A study testing Surveillance and treatment with azithromycin of newcomer and traveler families in people with Trachoma, run by Johns Hopkins University at 1 site in United States.
Trial summary
Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Trachoma
- What is being tested?
- Surveillance and treatment with azithromycin of newcomer and traveler families
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Census and Mass Drug Administration (MDA): All persons residing in the 52 study communities will be eligible for both the census and the annual mass azithromycin administrations.
- Intervention: In the 26 intervention communities, active surveillance for new families and returning travelers will be undertaken, and those meeting the criteria below will be eligible for family treatment with azithromycin if:
- Families are "newcomers" and
- They have children under 10 years of age
- They have moved into a new house in the community or into an existing household
- They plan to reside for at least 1 month in the study community and
Show all 25Show fewer
- They have moved from a community that has not had an MDA in the last year
- Families are classified as having traveled and
- They have children under 10 years of age
- They participated in a previous census in the same community
- They left the community for at least 8 weeks (2 months) for an area that has not received MDA in the past year and at least one child has returned and
- They have returned to reside in the community for at least 2 months
- Sentinel Children: In all 52 communities, samples of 135 children will be selected from the community census lists every six months for survey and examination.
- These children:
- must be between 1 year and 9.9 years of age,
- must be a resident in the community and not a short-term (less than 2 months) visitor,
- must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen,
- must be willing to have a swab taken as part of being a sentinel child (this is critical, as each swab result counts towards the criteria for stopping MDA), and
- must have an identifiable guardian capable of providing consent to participate.
- Adult Women: In all 52 communities, samples of 100 women will be selected from the baseline community census list.
- These women:
- must be aged 15 years and over
- must be a resident in the community and not a short term (less than 2 months) visitor
- must not have an ocular condition that precludes grading of scarring on upper conjunctiva
- must be able to provide informed consent.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that all communities would have annual rounds of MDA if infection is greater than 1% or follicular trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment program to identify and treat new families and families who travel after mass treatment. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. The proportion of communities that are able to stop mass treatment will be compared in the group of communities randomized to mass treatment plus the newcomer/traveler treatment program compared to the communities randomized to mass treatment alone after 24 months.
At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months will be surveyed at 30 months. At risk of trachoma re-infection communities have C. trachomatis infection rates less than or equal to 1% or TF < 5% at the time of the 18 month survey. Surveillance of communities for families that meet the newcomer or traveler status will extend 6 months beyond the 24 month survey to 30 months in the intervention communities only. A survey of sentinel children in the intervention and control communities at 30 months will be conducted to assess the level of trachoma and infection in all 38 communities at risk of trachoma re-emergence.
- Conditions
- Trachoma
- Being tested
- Surveillance and treatment with azithromycin of newcomer and traveler families, Usual care
- Keywords
- Trachoma, Azithromycin, Mass treatment
- Medical subject headings
- Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveillance and treatment with azithromycin of newcomer and traveler familiesOther
Also called Zithromax
The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration
Usual careOther
Also called Zithromax
Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community. Receives: Other: Surveillance and treatment with azithromycin of newcomer and traveler families; Other: Usual care |
| Usual Care | Active comparator | Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below
The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm
Measured: 24 months
Secondary outcomes (2)
The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below
Measured: 24 months
The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.
Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center.
If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval.
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionFeb 2016
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 TrachomaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Sheila K West, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767506
- Sponsor's protocol ID
- NA_00076305
- Other IDs
- U10EY022584
- Acronym
- ASANTE
- Status last verified
- Oct 2017
- First submitted
- 9 Jan 2013
- Last updated
- 9 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
West SK, Munoz B, Mkocha H, Dize L, Gaydos CA, Swenor B, Ervin AM, Quinn TC. Treating village newcomers and travelers for trachoma: Results from ASANTE cluster randomized trial. PLoS One. 2017 Jun 29;12(6):e0178595. doi: 10.1371/journal.pone.0178595. eCollection 2017.
PubMed 28662043
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
- ClinicalTrials.gov ID
- NCT01767506
- Acronym / sponsor ID
- ASANTE / NA_00076305
- Conditions
- Trachoma
- Keywords
- Trachoma, Azithromycin, Mass treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 14 Jan 2013 (estimated)
- Results
- Posted 9 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that all communities would have annual rounds of MDA if infection is greater than 1% or follicular trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment program to identify and treat new families and families who travel after mass treatment. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. The proportion of communities that are able to stop mass treatment will be compared in the group of communities randomized to mass treatment plus the newcomer/traveler treatment program compared to the communities randomized to mass treatment alone after 24 months.
At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months will be surveyed at 30 months. At risk of trachoma re-infection communities have C. trachomatis infection rates less than or equal to 1% or TF < 5% at the time of the 18 month survey. Surveillance of communities for families that meet the newcomer or traveler status will extend 6 months beyond the 24 month survey to 30 months in the intervention communities only. A survey of sentinel children in the intervention and control communities at 30 months will be conducted to assess the level of trachoma and infection in all 38 communities at risk of trachoma re-emergence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Surveillance and treatment with azithromycin of newcomer and traveler families, Other: Usual careCommunities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community. |
| Usual Care | Active comparator | Other: Usual careCommunities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (25 listed)
- Census and Mass Drug Administration (MDA): All persons residing in the 52 study communities will be eligible for both the census and the annual mass azithromycin administrations.
- Intervention: In the 26 intervention communities, active surveillance for new families and returning travelers will be undertaken, and those meeting the criteria below will be eligible for family treatment with azithromycin if:
- Families are "newcomers" and
- They have children under 10 years of age
- They have moved into a new house in the community or into an existing household
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Surveillance and treatment with azithromycin of newcomer and traveler familiesAlso: ZithromaxThe intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration | Other | Intervention |
| Usual careAlso: ZithromaxScheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. | Other | Intervention, Usual Care |
Primary outcome
The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below
Time frame: 24 months
The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm
2 secondary outcomes
The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below
Time frame: 24 months
The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.
Time frame: Baseline only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28662043West SK, Munoz B, Mkocha H, Dize L, Gaydos CA, Swenor B, Ervin AM, Quinn TC. Treating village newcomers and travelers for trachoma: Results from ASANTE cluster randomized trial. PLoS One. 2017 Jun 29;12(6):e0178595. doi: 10.1371/journal.pone.0178595. eCollection 2017.
- Individual participant dataSharing planned: Yes
Related trials for Trachoma
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
Active Trachoma
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Active, not recruitingPhase 4
Kebele Elimination of Trachoma for Ocular Health
Trachoma
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.
Sheila K West, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveillance and treatment with azithromycin of newcomer and traveler families in people with Trachoma, run by Johns Hopkins University at 1 site in United States.
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 25 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 9 Oct 2017. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2017). 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?
The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below (time frame: 24 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 NCT01767506, 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 9 Oct 2017.