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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01767506
First Posted: January 14, 2013
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: May 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Trachoma
Interventions: Other: Surveillance and treatment with azithromycin of newcomer and traveler families
Other: Usual care

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (community)

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Intervention   Usual Care
Participants Units (community) Participants Units (community)
STARTED    [1]   26    [2]   26 
COMPLETED    [3]   26    [3]   26 
NOT COMPLETED             
[1] 26 communities were randomized to intervention group The study was conducted at the community level.
[2] 26 communities were randomized to control group The study was conducted at the community level.
[3] The study was conducted at the community level.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
We collected and analyzed data on community level. Age and sex were not part of final analysis.

Reporting Groups
  Description
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.

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

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 Total of all reporting groups

Baseline Measures
   Intervention   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   26   52 
Overall Units Analyzed (Community) 
[Units: Community]
 26   26   52 
Age, Customized [1] [2] 
[Units: Community]
Count of Units
     
Participants Analyzed 
[Units: Participants]
 26   26   52 
Units Analyzed (Community) 
[Units: Community]
 26   26   52 
Age not analyzed at community level   NA [1]   NA [1]   NA [2] 
[1] We collected and analyzed data on community level.Age was not part of final analysis.
[2] Total not calculated because data are not available (NA) in one or more arms.
Sex: Female, Male [1] [2] 
[Units: Community]
Count of Units
     
Participants Analyzed 
[Units: Participants]
 26   26   52 
Units Analyzed (Community) 
[Units: Community]
 26   26   52 
Sex: Female, Male       
Female   NA [1]   NA [1]   NA [2] 
Male   NA [1]   NA [1]   NA [2] 
[1] We collected and analyzed data on community level.Sex was not part of final analysis.
[2] Total not calculated because data are not available (NA) in one or more arms.
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 0   0   0 
Participants Analyzed 
[Units: Participants]
 26   26   52 
Race and Ethnicity Not Collected         0 
[1] Race and Ethnicity were not collected from any participant.
Region of Enrollment 
[Units: Community]
     
Participants Analyzed 
[Units: Participants]
 26   26   52 
Units Analyzed (Community) 
[Units: Community]
 26   26   52 
Tanzania   26   26   52 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below   [ Time Frame: 24 months ]

2.  Secondary:   The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below   [ Time Frame: 24 months ]

3.  Secondary:   The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.   [ Time Frame: Baseline only ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.


Results Point of Contact:  
Name/Title: Sheila K West
Organization: Johns Hopkins University
phone: 410 955 2606
e-mail: shwest@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01767506     History of Changes
Other Study ID Numbers: NA_00076305
U10EY022584 ( U.S. NIH Grant/Contract )
First Submitted: January 9, 2013
First Posted: January 14, 2013
Results First Submitted: May 2, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017