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Partnership for Rapid Elimination of Trachoma (PRET)

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ClinicalTrials.gov Identifier: NCT00792922
Recruitment Status : Completed
First Posted : November 18, 2008
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Trachoma
Intervention: Drug: Azithromycin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

The study recruited communities with trachoma rates 20 % or higher from 3 countries - Tanzania, Gambia and Niger.

Protocol Enrollment refers to the number of communities, not the number of participants enrolled.

The final analysis was done at community level.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Reporting Groups
  Description
≥90% Coverage With Azithromycin Target

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

80%-89% Coverage With Azithromycin Target

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

≥90% Coverage With Azithromycin , Treatment Based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, treatment will be every 6-months for children ages twelve and under.

Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.

80%-89% Coverage With Azithromycin : Treatment Based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, treatment will be every 6-months for children ages twelve and under.

Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.


Participant Flow for 2 periods

Period 1:   At Baseline
    ≥90% Coverage With Azithromycin Target   80%-89% Coverage With Azithromycin Target   ≥90% Coverage With Azithromycin , Treatment Based   80%-89% Coverage With Azithromycin : Treatment Based
Participants Units (community) Participants Units (community) Participants Units (community) Participants Units (community)
STARTED    [1]   32    [1]   32    [1]   32    [1]   32 
Niger    [1]   12    [1]   12    [1]   12    [1]   12 
Gambia    [1]   12    [1]   12    [1]   12    [1]   12 
Tanzania    [1]   8    [1]   8    [1]   8    [1]   8 
COMPLETED    [1]   32    [1]   32    [1]   32    [1]   32 
NOT COMPLETED                         
[1] the trial was conducted at community level and data reported per community basis

Period 2:   At 3 Years
    ≥90% Coverage With Azithromycin Target   80%-89% Coverage With Azithromycin Target   ≥90% Coverage With Azithromycin , Treatment Based   80%-89% Coverage With Azithromycin : Treatment Based
Participants Units (community) Participants Units (community) Participants Units (community) Participants Units (community)
STARTED    [1]   40    [1]   40    [1]   24    [1]   24 
Niger    [2]   12    [2]   12    [2]   12    [2]   12 
Gambia    [2]   12    [2]   12    [2]   12    [2]   12 
Tanzania    [2]   16    [2]   16    [2]   0    [2]   0 
COMPLETED    [2]   40    [2]   40    [2]   24    [2]   24 
NOT COMPLETED                         
[1] In Tanzania, units in treatment arm analyzed with antibiotic arm as tf rate was not <5% by 18 months the trial was conducted at community level and data reported per community basis
[2] the trial was conducted at community level and data reported per community basis



  Baseline Characteristics

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.

For the final analysis the main effect of stop rule was not considered in Tanzania since no communities had prevalence < 5%.Only the main effect of coverage was analyzed there.

In Gambia and Niger stop rule was applied and analyzed along with the main effect of coverage.


Reporting Groups
  Description
≥90% Coverage With Azithromycin Target

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

80%-89% Coverage With Azithromycin Target

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

≥90% Coverage With Azithromycin , Treatment Based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, treatment will be every 6-months for children ages twelve and under.

Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.

80%-89% Coverage With Azithromycin : Treatment Based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, treatment will be every 6-months for children ages twelve and under.

Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.

Total Total of all reporting groups

Baseline Measures
   ≥90% Coverage With Azithromycin Target   80%-89% Coverage With Azithromycin Target   ≥90% Coverage With Azithromycin , Treatment Based   80%-89% Coverage With Azithromycin : Treatment Based   Total 
Overall Units Analyzed (Community) 
[Units: Community]
 40   40   24   24   128 
Age, Customized [1] [2] 
[Units: Community]
Count of Units
         
Age not analyzed   NA [1]   NA [1]   NA [1]   NA [1]   NA [2] 
[1] We collected and analyzed data at 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/Gender, Customized [1] [2] [3] 
[Units: Community]
Count of Units
         
Sex/Gender not analyzed   NA [2]   NA [2]   NA [2]   NA [2]   NA [3] 
[1] We collected and analyzed data at community level.Sex/Gender was not part of final analysis.
[2] We analyzed the data on community level. Gender was not part of final analyses
[3] Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment [1] 
[Units: Community]
         
Tanzania   16   16   0   0   32 
Gambia   12   12   12   12   48 
Niger   12   12   12   12   48 
[1] We collected and analyzed data at community level.


  Outcome Measures

1.  Primary:   Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline   [ Time Frame: At baseline ]

2.  Primary:   Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  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

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00792922     History of Changes
Other Study ID Numbers: NA_00018439
First Submitted: November 17, 2008
First Posted: November 18, 2008
Results First Submitted: April 13, 2017
Results First Posted: July 18, 2017
Last Update Posted: July 18, 2017