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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
Enrollment 128
Recruitment Details

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  
Arm/Group Title ≥90% Coverage With Azithromycin Target 80%-89% Coverage With Azithromycin Target ≥90% Coverage With Azithromycin , Treatment Based 80%-89% Coverage With Azithromycin : Treatment Based
Hide Arm/Group Description

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

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.

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.

Period Title: At Baseline
Number of participants Number of units (community) Number of participants Number of units (community) Number of participants Number of units (community) Number of participants Number of units (community)
Started NA [1] 32 NA [1] 32 NA [1] 32 NA [1] 32
Niger NA [1] 12 NA [1] 12 NA [1] 12 NA [1] 12
Gambia NA [1] 12 NA [1] 12 NA [1] 12 NA [1] 12
Tanzania NA [1] 8 NA [1] 8 NA [1] 8 NA [1] 8
Completed NA [1] 32 NA [1] 32 NA [1] 32 NA [1] 32
Not Completed NA 0 NA 0 NA 0 NA 0
[1]
the trial was conducted at community level and data reported per community basis
Period Title: At 3 Years
Number of participants Number of units (community) Number of participants Number of units (community) Number of participants Number of units (community) Number of participants Number of units (community)
Started NA [1] 40 NA [1] 40 NA [1] 24 NA [1] 24
Niger NA [2] 12 NA [2] 12 NA [2] 12 NA [2] 12
Gambia NA [2] 12 NA [2] 12 NA [2] 12 NA [2] 12
Tanzania NA [2] 16 NA [2] 16 NA [2] 0 NA [2] 0
Completed NA [2] 40 NA [2] 40 NA [2] 24 NA [2] 24
Not Completed NA 0 NA 0 NA 0 NA 0
[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
Arm/Group Title ≥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
Hide Arm/Group Description

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

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.

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 of all reporting groups
Overall Number of Baseline Participants NA NA NA NA 0
Overall Number of Units Analyzed
Type of Units Analyzed: Community
40 40 24 24 128
Hide Baseline Analysis Population Description
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.
Age, Customized   [1] 
Count of Units
Unit of measure:  Community
Age not analyzed Number Analyzed 40 community 40 community 24 community 24 community 128 community [2] 
NA [3]  NA [3]  NA [3]  NA [3]  NA [4] 
[1]
Measure Analysis Population Description: We collected and analyzed data at community level.Age was not part of final analysis.
[2]
NA participants
[3]
We collected and analyzed data at community level.Age was not part of final analysis.
[4]
Total not calculated because data are not available (NA) in one or more arms.
Sex/Gender, Customized   [1] 
Count of Units
Unit of measure:  Community
Sex/Gender not analyzed Number Analyzed 40 community 40 community 24 community 24 community 128 community [2] 
NA [3]  NA [3]  NA [3]  NA [3]  NA [4] 
[1]
Measure Analysis Population Description: We collected and analyzed data at community level.Sex/Gender was not part of final analysis.
[2]
NA participants
[3]
We analyzed the data on community level. Gender was not part of final analyses
[4]
Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Community
Number Analyzed 40 community 40 community 24 community 24 community 128 community [2] 
Tanzania 16 16 0 0 32
Gambia 12 12 12 12 48
Niger 12 12 12 12 48
[1]
Measure Analysis Population Description: We collected and analyzed data at community level.
[2]
NA participants
1.Primary Outcome
Title Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
Hide Description

Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.

The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.

Time Frame At baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

At baseline 8 communities were randomized to each arm in Tanzania, 12 communities were randomized to each arm in Gambia and Niger.

Stop rule could not be applied in Tanzania.Communities in stop arm were moved to ≥90% coverage or 80%-89% coverage with azithromycin target arm and only main effect of coverage was analyzed in Tanzania.

Arm/Group Title ≥90% Coverage With Azithromycin Target 80%-89% Coverage With Azithromycin Target ≥90% Coveage With Azithromycin , Treatment Based 80%-89% Coverage With Azithromycin : Treatment Based
Hide Arm/Group Description:

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

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.

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.

Overall Number of Participants Analyzed NA NA NA NA
Overall Number of Units Analyzed
Type of Units Analyzed: Community
40 40 24 24
Mean (Standard Deviation)
Unit of Measure: community
Prevalence of trachoma in Tanzania at baseline Number Analyzed 8 community 8 community 8 community 8 community
30.7  (16.3) 30.3  (13.5) 31.1  (9.5) 30.5  (10.4)
C.trachomatis infection in Tanzania at baseline Number Analyzed 8 community 8 community 8 community 8 community
24.6  (12.4) 17.8  (10.3) 23.0  (11.2) 22.4  (23.3)
prevalence of trachoma in Gambia at baseline Number Analyzed 12 community 12 community 12 community 12 community
7.4  (26.1) 5.6  (23.1) 6.2  (24.1) 6.1  (23.8)
C.trachomatis infection in Gambia at baseline Number Analyzed 12 community 12 community 12 community 12 community
0.9  (9.9) 0.7  (8.6) 1.2  (10.8) 0.2  (2.9)
prevalence of trachoma in Niger at baseline Number Analyzed 12 community 12 community 12 community 12 community
28.4  (13.9) 27.0  (17.3) 23.9  (12.0) 24.7  (13.0)
C.trachomatis infection in Niger at baseline Number Analyzed 12 community 12 community 12 community 12 community
21.9  (16.7) 20.5  (16.8) 15.6  (8.8) 24.9  (14.1)
2.Primary Outcome
Title Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
Hide Description

100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia.

50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.

Outcomes are reported at the community level because raw data could not be accessed.

There is no way to determine how many participants were examined in each arm.

Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
We analyzed and reported the results of the trial at community level.
Arm/Group Title ≥90% Coverage With Azithromycin Target 80%-89% Coverage With Azithromycin Target ≥90% Coveage With Azithromycin, Treatment Based 80%-89% Coverage With Azithromycin: Treatment Based
Hide Arm/Group Description:

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

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.

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.

Overall Number of Participants Analyzed NA NA NA NA
Overall Number of Units Analyzed
Type of Units Analyzed: Community
40 40 24 24
Mean (Standard Deviation)
Unit of Measure: community
Prevalence of trachoma (TF) in Tanzania at 3 years Number Analyzed 16 community 16 community 0 community 0 community
9.0  (5.9) 6.1  (4.0)
C.trachomatis infection in Tanzania at 3 years Number Analyzed 16 community 16 community 0 community 0 community
5.4  (3.7) 4.0  (2.7)
Prevalence of trachoma (TF) in Gambia at 3 years Number Analyzed 12 community 12 community 12 community 12 community
3.0  (17.1) 2.3  (14.9) 3.2  (17.6) 2.5  (15.7)
C.trachomatis infection in Gambia at 3 years Number Analyzed 12 community 12 community 12 community 12 community
0.2  (4.1) 1.0  (9.5) 0.7  (8.2) 0.2  (4.2)
Prevalence of trachoma (TF) in Niger at 3 years Number Analyzed 12 community 12 community 12 community 12 community
8.9  (8.8) 7.1  (7.8) 5.4  (3.9) 10.1  (10.5)
C.trachomatis infection in Niger at 3 years Number Analyzed 12 community 12 community 12 community 12 community
7.1  (6.8) 4.6  (7.9) 3.3  (3.6) 4.4  (6.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ≥90% Coverage With Azithromycin Target, 80%-89% Coverage With Azithromycin Target
Comments

This is analysis done in Tanzania:

Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection.

Type of Statistical Test Superiority
Comments Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm & parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % & 97.5 % percentiles were reported.
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-1 to 3.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 80%-89% Coverage With Azithromycin Target
Comments

This is the analysis done in Tanzania:

Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.

Here we are looking at the prevalence of trachoma

Type of Statistical Test Superiority
Comments For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported.
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Ordinary least squares linear regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.6
Confidence Interval (2-Sided) 95%
-0.3 to 5.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ≥90% Coverage With Azithromycin Target, 80%-89% Coverage With Azithromycin Target, ≥90% Coveage With Azithromycin, Treatment Based, 80%-89% Coverage With Azithromycin: Treatment Based
Comments

This is the statistical analysis for Niger:

We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-11.1 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ≥90% Coverage With Azithromycin Target, 80%-89% Coverage With Azithromycin Target, ≥90% Coveage With Azithromycin, Treatment Based, 80%-89% Coverage With Azithromycin: Treatment Based
Comments

This is the statistical analysis for Niger:

We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-7.7 to 12.5
Estimation Comments [Not Specified]
Time Frame 3 years
Adverse Event Reporting Description

Mass drug administration was done for all the communities in each branch. Adverse events were planned to be collected per community per arm.

No adverse event was reported in any community in all three countries.

 
Arm/Group Title ≥90% Coverage With Azithromycin Target 80%-89% Coverage With Azithromycin Target ≥90% Coverage With Azithromycin , Treatment Based 80%-89% Coverage With Azithromycin : Treatment Based
Hide Arm/Group Description

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

Selected communities will receive mass treatment annually for three years.

Azithromycin: Comparison of community coverage rate

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.

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.

All-Cause Mortality
≥90% Coverage With Azithromycin Target 80%-89% Coverage With Azithromycin Target ≥90% Coverage With Azithromycin , Treatment Based 80%-89% Coverage With Azithromycin : Treatment Based
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
≥90% Coverage With Azithromycin Target 80%-89% Coverage With Azithromycin Target ≥90% Coverage With Azithromycin , Treatment Based 80%-89% Coverage With Azithromycin : Treatment Based
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%)   0/32 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
≥90% Coverage With Azithromycin Target 80%-89% Coverage With Azithromycin Target ≥90% Coverage With Azithromycin , Treatment Based 80%-89% Coverage With Azithromycin : Treatment Based
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%)   0/32 (0.00%)   0/32 (0.00%) 
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
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