Trial Outcomes & Findings for A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial (NCT NCT01767506)

NCT ID: NCT01767506

Last Updated: 2017-10-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2017-10-09

Participant Flow

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.

Unit of analysis: community

Participant milestones

Measure	Intervention 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	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. 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.
Overall Study STARTED	0 26	0 26
Overall Study COMPLETED	0 26	0 26
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=26 community 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	Usual Care n=26 community 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 n=52 community Total of all reporting groups
Age, Customized Age not analyzed at community level	NA community n=26 community	NA community n=26 community	NA community n=52 community
Sex: Female, Male Female	NA community n=26 community	NA community n=26 community	NA community n=52 community
Sex: Female, Male Male	NA community n=26 community	NA community n=26 community	NA community n=52 community
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Tanzania	26 community n=26 community	26 community n=26 community	52 community n=52 community

PRIMARY outcome

Timeframe: 24 months

Population: The trial was conducted at the community level

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

Outcome measures

Measure	Intervention n=26 community 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	Usual Care n=26 community 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.
The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below	7 community	4 community

SECONDARY outcome

Timeframe: 24 months

Population: The trial was conducted at the community level

Outcome measures

Measure	Intervention n=26 community 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	Usual Care n=26 community 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.
The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below	21 community	20 community

SECONDARY outcome

Timeframe: Baseline only

Population: The trial was conducted at the community level

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.

Outcome measures

Measure	Intervention n=26 community 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	Usual Care n=26 community 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.
The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.	5.2 community Interval 3.7 to 6.6	4.9 community Interval 3.2 to 6.5

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sheila K West

Johns Hopkins University

Phone: 410 955 2606

Email: shwest@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place