Trial Outcomes & Findings for Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia (NCT NCT00347776)
NCT ID: NCT00347776
Last Updated: 2017-08-07
Results Overview
Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.
COMPLETED
PHASE4
1452 participants
Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery
2017-08-07
Participant Flow
Patients were randomly assigned initially to receive single dose of oral azithromycin to subject or single dose of azithromycin to subject \& immediate family members or topical tetracycline ointment to subject groups.1 yr data suggested no difference in outcome between 2 azithromycin arms.These 2 groups were combined into 1 group in final analysis.
Participant milestones
| Measure |
Control
Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
|
Intervention 1
Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g)
|
Intervention 2
Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
|
|---|---|---|---|
|
1.5 Month Follow-up
STARTED
|
484
|
483
|
485
|
|
1.5 Month Follow-up
COMPLETED
|
470
|
475
|
473
|
|
1.5 Month Follow-up
NOT COMPLETED
|
14
|
8
|
12
|
|
6 Month Follow-up
STARTED
|
470
|
475
|
473
|
|
6 Month Follow-up
COMPLETED
|
448
|
462
|
455
|
|
6 Month Follow-up
NOT COMPLETED
|
22
|
13
|
18
|
|
12 Month Follow-up
STARTED
|
448
|
462
|
455
|
|
12 Month Follow-up
COMPLETED
|
425
|
446
|
436
|
|
12 Month Follow-up
NOT COMPLETED
|
23
|
16
|
19
|
Reasons for withdrawal
| Measure |
Control
Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
|
Intervention 1
Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g)
|
Intervention 2
Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
|
|---|---|---|---|
|
1.5 Month Follow-up
Death
|
2
|
0
|
0
|
|
1.5 Month Follow-up
reached the endpoint
|
12
|
8
|
12
|
|
6 Month Follow-up
Death
|
2
|
1
|
3
|
|
6 Month Follow-up
reached endpont
|
20
|
12
|
15
|
|
12 Month Follow-up
Lost to Follow-up
|
7
|
6
|
6
|
|
12 Month Follow-up
Death
|
3
|
4
|
4
|
|
12 Month Follow-up
Reached endpoint
|
13
|
6
|
9
|
Baseline Characteristics
Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
Baseline characteristics by cohort
| Measure |
Control
n=484 Participants
Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks
|
Intervention1
n=483 Participants
Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
|
Intervention2
n=485 Participants
Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
|
Total
n=1452 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.0 years
STANDARD_DEVIATION 12.8 • n=39 Participants
|
48.5 years
STANDARD_DEVIATION 13.0 • n=41 Participants
|
50.0 years
STANDARD_DEVIATION 12.6 • n=35 Participants
|
48.9 years
STANDARD_DEVIATION 13.0 • n=31 Participants
|
|
Sex: Female, Male
Female
|
390 Participants
n=39 Participants
|
366 Participants
n=41 Participants
|
365 Participants
n=35 Participants
|
1121 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=39 Participants
|
117 Participants
n=41 Participants
|
120 Participants
n=35 Participants
|
331 Participants
n=31 Participants
|
|
Region of Enrollment
Ethiopia
|
484 Participants
n=39 Participants
|
483 Participants
n=41 Participants
|
485 Participants
n=35 Participants
|
1452 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgeryPopulation: Recurrence rates (expressed as person-years) in the tetracycline arm was compared with the 2 azithromycin arms combined (483+ 485= 968 participants)
Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.
Outcome measures
| Measure |
Control
n=484 Participants
Topical tetracycline
Antibiotic:Topical tetracycline
|
Intervention
n=968 Participants
The two azithromycin groups combined
Antibiotic: Oral Azithromycin
|
|---|---|---|
|
Recurrent Trichiasis in Tetracycline and Azithromycin Groups
|
45 Participants
|
62 Participants
|
PRIMARY outcome
Timeframe: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgeryRecurrence of trichiasis :Clinical assessment for recurrence was done by looking for one or more eye lashes touching globe or evidence of epilation. If there was evidence of epilation or if one or more eye lashes were touching the globe, it was considered as recurrence of trichiasis.
Outcome measures
| Measure |
Control
n=483 Participants
Topical tetracycline
Antibiotic:Topical tetracycline
|
Intervention
n=485 Participants
The two azithromycin groups combined
Antibiotic: Oral Azithromycin
|
|---|---|---|
|
Recurrent Trichiasis Between Two Azithromycin Arms
|
26 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 6 weeksThe surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.
Outcome measures
| Measure |
Control
n=484 Participants
Topical tetracycline
Antibiotic:Topical tetracycline
|
Intervention
n=968 Participants
The two azithromycin groups combined
Antibiotic: Oral Azithromycin
|
|---|---|---|
|
Surgical Failure
|
12 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6 weeksAt 6 weeks participants/family members were asked about any hospitalization,death,ocular complaints, gastrointestinal illness or other specific illness or any clinic visit within six weeks of receiving surgery.
Outcome measures
| Measure |
Control
n=484 Participants
Topical tetracycline
Antibiotic:Topical tetracycline
|
Intervention
n=968 Participants
The two azithromycin groups combined
Antibiotic: Oral Azithromycin
|
|---|---|---|
|
Adverse Events
Gastrointestinal complaints/other specific illness
|
6 Participants
|
22 Participants
|
|
Adverse Events
Ocular complaints
|
7 Participants
|
6 Participants
|
Adverse Events
Control
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=484 participants at risk
Topical tetracycline
Antibiotic:Topical tetracycline
|
Intervention
n=968 participants at risk
The two azithromycin groups combined
Antibiotic: Oral Azithromycin
|
|---|---|---|
|
Surgical and medical procedures
1.5 months
|
1.4%
7/484 • At 1.5 months ( 6 weeks) post surgery.Adverse events were defined as death, hospitalization, gastrointestinal illness or other specific illness,ocular complaints. Events were assessed without regard to the specific Adverse Event Term.
At the 1.5-month follow-up visit, specific questions were asked of each subject about himself/herself and all his/her family members about these adverse events. The interviewer was either a physician or a medical assistant
|
0.62%
6/968 • At 1.5 months ( 6 weeks) post surgery.Adverse events were defined as death, hospitalization, gastrointestinal illness or other specific illness,ocular complaints. Events were assessed without regard to the specific Adverse Event Term.
At the 1.5-month follow-up visit, specific questions were asked of each subject about himself/herself and all his/her family members about these adverse events. The interviewer was either a physician or a medical assistant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place