Trial Outcomes & Findings for Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger (NCT NCT00618449)
NCT ID: NCT00618449
Last Updated: 2012-05-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1139 participants
Primary outcome timeframe
1-year post-treatment
Results posted on
2012-05-08
Participant Flow
Recruitment period Jan-08 thru May-09 in ten villages within the Maradi Region of Niger with high prevalence of clinically active trachoma amongst children\<= age 10.
Participant milestones
| Measure |
Two-doses of Azithromycin
Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
Single-dose Azithromcyin
Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
|---|---|---|
|
Overall Study
STARTED
|
679
|
668
|
|
Overall Study
1-month, Post-treatment
|
666
|
656
|
|
Overall Study
1-year, Post-treatment
|
581
|
558
|
|
Overall Study
COMPLETED
|
581
|
558
|
|
Overall Study
NOT COMPLETED
|
98
|
110
|
Reasons for withdrawal
| Measure |
Two-doses of Azithromycin
Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
Single-dose Azithromcyin
Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
98
|
110
|
Baseline Characteristics
Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
Baseline characteristics by cohort
| Measure |
Two-doses of Azithromycin
n=679 Participants
Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
Single-dose Azithromcyin
n=668 Participants
Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
Total
n=1347 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
18.47 years
STANDARD_DEVIATION 17.77 • n=5 Participants
|
19.25 years
STANDARD_DEVIATION 18.66 • n=7 Participants
|
18.86 years
STANDARD_DEVIATION 18.22 • n=5 Participants
|
|
Age, Customized
<=10 years
|
350 participants
n=5 Participants
|
345 participants
n=7 Participants
|
695 participants
n=5 Participants
|
|
Age, Customized
Between 11 and 65 years
|
313 participants
n=5 Participants
|
309 participants
n=7 Participants
|
622 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
352 Participants
n=5 Participants
|
354 Participants
n=7 Participants
|
706 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
327 Participants
n=5 Participants
|
314 Participants
n=7 Participants
|
641 Participants
n=5 Participants
|
|
Region of Enrollment
Niger
|
679 participants
n=5 Participants
|
668 participants
n=7 Participants
|
1347 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1-year post-treatmentPopulation: Per protocol.
Outcome measures
| Measure |
Two-doses of Azithromycin
n=679 Participants
Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
Single-dose Azithromcyin
n=668 Participants
Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
|
|---|---|---|
|
Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]
1-year, post treatment
|
19 Participants
|
12 Participants
|
|
Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]
Baseline, Day-0
|
57 Participants
|
42 Participants
|
|
Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]
1-month, post-treatment
|
5 Participants
|
3 Participants
|
Adverse Events
Two-doses of Azithromycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Single-dose Azithromcyin
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
Julius Schachter, PhD / Emeritus Professor of Laboratory Medicine
University of California, San Francisco
Phone: +1 (415) 824-5115
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place