A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01767506
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Trachoma	Other: Surveillance and treatment with azithromycin of newcomer and traveler families; Other: Usual care	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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.	Other: Surveillance and treatment with azithromycin of newcomer and traveler families; 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; Other Names: Zithromax ; Other: Usual care; 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.; Other Names: Zithromax
Active Comparator: Usual Care 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.	Other: Usual care; 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.; Other Names: Zithromax

Outcome Measures

Primary Outcome Measures

1. The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below [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

Secondary Outcome Measures

1. The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below [24 months]

2. The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms. [Baseline only]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

• 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.

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University
• National Eye Institute (NEI)

Investigators

• Principal Investigator: Sheila K West, PhD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01767506
• Other Study ID Numbers: NA_00076305; U10EY022584
• First Posted: Jan 14, 2013
• Last Update Posted: Oct 9, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Johns Hopkins University: Trachoma; Azithromycin; Mass treatment
• Additional relevant MeSH terms: Trachoma; Azithromycin

Study Results

Participant Flow

Pre-assignment Detail	The trial was conducted at the community level and not at the participant level.Therefore, we are presenting the data only at the community level.

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	Communities will receive usual care,including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or Follicular Trachoma (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. Surveillance and treatment with azithromycin of newcomer and traveler families: 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 care: Scheduled 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-e	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. Usual care: 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.
Period Title: Overall Study
STARTED	NA	NA
COMPLETED	NA	NA
NOT COMPLETED	NA	NA

Baseline Characteristics

Arm/Group Title	Intervention	Usual Care	Total
Arm/Group Description	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. Surveillance and treatment with azithromycin of newcomer and traveler families: 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 care: 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-e	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. Usual care: 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.	Total of all reporting groups
Overall Participants	26	26	52
Overall community	26	26	52
Age, Customized (community) [Count of Units]
Age not analyzed at community level	NA	NA	NA
Sex: Female, Male (community) [Count of Units]
Female	NA	NA	NA
Male	NA	NA	NA
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (community) [Number]
Tanzania	26	26	52

Outcome Measures

1. Primary Outcome

Title	The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below
Description	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
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The trial was conducted at the community level

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	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. Surveillance and treatment with azithromycin of newcomer and traveler families: 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 care: 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-e	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. Usual care: 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.
Measure Participants	NA	NA
Measure community	26	26
Count of Units [community]	7	4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 0.56 to 11.9
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		The null hypothesis was that we could further decrease infection to 1% or less in more of the communities in the surveillance intervention arm, compared to control communities.

2. Secondary Outcome

Title	The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

The trial was conducted at the community level

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	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. Surveillance and treatment with azithromycin of newcomer and traveler families: 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 care: 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-e	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. Usual care: 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.
Measure Participants	NA	NA
Measure community	26	26
Count of Units [community]	21	20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Usual Care
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	1
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.9
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.
Description	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.
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

The trial was conducted at the community level

Arm/Group Title	Intervention	Usual Care
Arm/Group Description	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. Surveillance and treatment with azithromycin of newcomer and traveler families: 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 care: 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-e	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. Usual care: 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.
Measure Participants	NA	NA
Measure community	26	26
Mean (95% Confidence Interval) [community]	5.2	4.9

Adverse Events

Time Frame	Adverse event data were collected for 24 months. The Community Health Workers collected data on adverse events after each newcomer and traveler family was identified and treated.
Arm/Group Title	Intervention		Usual Care
Arm/Group Description	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. Surveillance and treatment with azithromycin of newcomer and traveler families: 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 care: 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-e		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. Usual care: 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.
All Cause Mortality
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Serious Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.