Trial Outcomes & Findings for Partnership for Rapid Elimination of Trachoma (NCT NCT00792922)
NCT ID: NCT00792922
Last Updated: 2017-07-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
128 participants
Primary outcome timeframe
At baseline
Results posted on
2017-07-18
Participant Flow
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.
Unit of analysis: community
Participant milestones
| Measure |
≥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.
|
|---|---|---|---|---|
|
At Baseline
STARTED
|
0 32
|
0 32
|
0 32
|
0 32
|
|
At Baseline
Niger
|
0 12
|
0 12
|
0 12
|
0 12
|
|
At Baseline
Gambia
|
0 12
|
0 12
|
0 12
|
0 12
|
|
At Baseline
Tanzania
|
0 8
|
0 8
|
0 8
|
0 8
|
|
At Baseline
COMPLETED
|
0 32
|
0 32
|
0 32
|
0 32
|
|
At Baseline
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
At 3 Years
STARTED
|
0 40
|
0 40
|
0 24
|
0 24
|
|
At 3 Years
Niger
|
0 12
|
0 12
|
0 12
|
0 12
|
|
At 3 Years
Gambia
|
0 12
|
0 12
|
0 12
|
0 12
|
|
At 3 Years
Tanzania
|
0 16
|
0 16
|
0 0
|
0 0
|
|
At 3 Years
COMPLETED
|
0 40
|
0 40
|
0 24
|
0 24
|
|
At 3 Years
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
We collected and analyzed data at community level.Age was not part of final analysis.
Baseline characteristics by cohort
| Measure |
≥90% Coverage With Azithromycin Target
n=40 community
Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate
|
80%-89% Coverage With Azithromycin Target
n=40 community
Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate
|
≥90% Coverage With Azithromycin , Treatment Based
n=24 community
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
n=24 community
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
n=128 community
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age not analyzed
|
NA community
n=40 community • We collected and analyzed data at community level.Age was not part of final analysis.
|
NA community
n=40 community • We collected and analyzed data at community level.Age was not part of final analysis.
|
NA community
n=24 community • We collected and analyzed data at community level.Age was not part of final analysis.
|
NA community
n=24 community • We collected and analyzed data at community level.Age was not part of final analysis.
|
NA community
n=128 community • We collected and analyzed data at community level.Age was not part of final analysis.
|
|
Sex/Gender, Customized
Sex/Gender not analyzed
|
NA community
n=40 community • We collected and analyzed data at community level.Sex/Gender was not part of final analysis.
|
NA community
n=40 community • We collected and analyzed data at community level.Sex/Gender was not part of final analysis.
|
NA community
n=24 community • We collected and analyzed data at community level.Sex/Gender was not part of final analysis.
|
NA community
n=24 community • We collected and analyzed data at community level.Sex/Gender was not part of final analysis.
|
NA community
n=128 community • We collected and analyzed data at community level.Sex/Gender was not part of final analysis.
|
|
Region of Enrollment
Tanzania
|
16 community
n=40 community • We collected and analyzed data at community level.
|
16 community
n=40 community • We collected and analyzed data at community level.
|
0 community
n=24 community • We collected and analyzed data at community level.
|
0 community
n=24 community • We collected and analyzed data at community level.
|
32 community
n=128 community • We collected and analyzed data at community level.
|
|
Region of Enrollment
Gambia
|
12 community
n=40 community • We collected and analyzed data at community level.
|
12 community
n=40 community • We collected and analyzed data at community level.
|
12 community
n=24 community • We collected and analyzed data at community level.
|
12 community
n=24 community • We collected and analyzed data at community level.
|
48 community
n=128 community • We collected and analyzed data at community level.
|
|
Region of Enrollment
Niger
|
12 community
n=40 community • We collected and analyzed data at community level.
|
12 community
n=40 community • We collected and analyzed data at community level.
|
12 community
n=24 community • We collected and analyzed data at community level.
|
12 community
n=24 community • We collected and analyzed data at community level.
|
48 community
n=128 community • We collected and analyzed data at community level.
|
PRIMARY outcome
Timeframe: At baselinePopulation: 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.
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.
Outcome measures
| Measure |
≥90% Coverage With Azithromycin Target
n=40 community
Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate
|
80%-89% Coverage With Azithromycin Target
n=40 community
Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate
|
≥90% Coveage With Azithromycin , Treatment Based
n=24 community
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
n=24 community
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.
|
|---|---|---|---|---|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
Prevalence of trachoma in Tanzania at baseline
|
30.7 community
Standard Deviation 16.3
|
30.3 community
Standard Deviation 13.5
|
31.1 community
Standard Deviation 9.5
|
30.5 community
Standard Deviation 10.4
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
C.trachomatis infection in Tanzania at baseline
|
24.6 community
Standard Deviation 12.4
|
17.8 community
Standard Deviation 10.3
|
23.0 community
Standard Deviation 11.2
|
22.4 community
Standard Deviation 23.3
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
prevalence of trachoma in Gambia at baseline
|
7.4 community
Standard Deviation 26.1
|
5.6 community
Standard Deviation 23.1
|
6.2 community
Standard Deviation 24.1
|
6.1 community
Standard Deviation 23.8
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
prevalence of trachoma in Niger at baseline
|
28.4 community
Standard Deviation 13.9
|
27.0 community
Standard Deviation 17.3
|
23.9 community
Standard Deviation 12.0
|
24.7 community
Standard Deviation 13.0
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
C.trachomatis infection in Gambia at baseline
|
0.9 community
Standard Deviation 9.9
|
0.7 community
Standard Deviation 8.6
|
1.2 community
Standard Deviation 10.8
|
0.2 community
Standard Deviation 2.9
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
C.trachomatis infection in Niger at baseline
|
21.9 community
Standard Deviation 16.7
|
20.5 community
Standard Deviation 16.8
|
15.6 community
Standard Deviation 8.8
|
24.9 community
Standard Deviation 14.1
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: We analyzed and reported the results of the trial at community level.
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.
Outcome measures
| Measure |
≥90% Coverage With Azithromycin Target
n=40 community
Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate
|
80%-89% Coverage With Azithromycin Target
n=40 community
Selected communities will receive mass treatment annually for three years.
Azithromycin: Comparison of community coverage rate
|
≥90% Coveage With Azithromycin , Treatment Based
n=24 community
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
n=24 community
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.
|
|---|---|---|---|---|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
Prevalence of trachoma (TF) in Tanzania at 3 years
|
9.0 community
Standard Deviation 5.9
|
6.1 community
Standard Deviation 4.0
|
—
|
—
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
C.trachomatis infection in Tanzania at 3 years
|
5.4 community
Standard Deviation 3.7
|
4.0 community
Standard Deviation 2.7
|
—
|
—
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
Prevalence of trachoma (TF) in Gambia at 3 years
|
3.0 community
Standard Deviation 17.1
|
2.3 community
Standard Deviation 14.9
|
3.2 community
Standard Deviation 17.6
|
2.5 community
Standard Deviation 15.7
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
C.trachomatis infection in Gambia at 3 years
|
0.2 community
Standard Deviation 4.1
|
1.0 community
Standard Deviation 9.5
|
0.7 community
Standard Deviation 8.2
|
0.2 community
Standard Deviation 4.2
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
Prevalence of trachoma (TF) in Niger at 3 years
|
8.9 community
Standard Deviation 8.8
|
7.1 community
Standard Deviation 7.8
|
5.4 community
Standard Deviation 3.9
|
10.1 community
Standard Deviation 10.5
|
|
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
C.trachomatis infection in Niger at 3 years
|
7.1 community
Standard Deviation 6.8
|
4.6 community
Standard Deviation 7.9
|
3.3 community
Standard Deviation 3.6
|
4.4 community
Standard Deviation 6.0
|
Adverse Events
≥90% Coverage With Azithromycin Target
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
80%-89% Coverage With Azithromycin Target
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
≥90% Coverage With Azithromycin , Treatment Based
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
80%-89% Coverage With Azithromycin : Treatment Based
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place