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Trial record 23 of 201 for:    TETRACYCLINE

Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00347776
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborators:
National Eye Institute (NEI)
Project ORBIS
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Trichiasis
Interventions Drug: azithromycin
Drug: topical tetracycline
Enrollment 1452
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Control Intervention 1 Intervention 2
Hide Arm/Group Description Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g) Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
Period Title: 1.5 Month Follow-up
Started 484 483 485
Completed 470 475 [1] 473 [2]
Not Completed 14 8 12
Reason Not Completed
Death             2             0             0
reached the endpoint             12             8             12
[1]
473 had no recurrence.2 were lost to follow-up but were still eligible for follow-up at next visits
[2]
472 had no recurrence.1 was lost to follow-up but was still eligible for follow-up at next visits
Period Title: 6 Month Follow-up
Started 470 475 473
Completed 448 [1] 462 [2] 455 [3]
Not Completed 22 13 18
Reason Not Completed
Death             2             1             3
reached endpont             20             12             15
[1]
440 had no recurrence.8 were lost to follow-up but were still eligible for follow-up at next visits
[2]
459 had no recurrence.3 were lost to follow-up but were still eligible for follow-up at next visits
[3]
452 had no recurrence.3 were lost to follow-up but were still eligible for follow-up at next visits
Period Title: 12 Month Follow-up
Started 448 462 455
Completed 425 446 436
Not Completed 23 16 19
Reason Not Completed
Lost to Follow-up             7             6             6
Death             3             4             4
Reached endpoint             13             6             9
Arm/Group Title Control Intervention1 Intervention2 Total
Hide Arm/Group Description Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g) Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g) Total of all reporting groups
Overall Number of Baseline Participants 484 483 485 1452
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 484 participants 483 participants 485 participants 1452 participants
48.0  (12.8) 48.5  (13.0) 50.0  (12.6) 48.9  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 484 participants 483 participants 485 participants 1452 participants
Female
390
  80.6%
366
  75.8%
365
  75.3%
1121
  77.2%
Male
94
  19.4%
117
  24.2%
120
  24.7%
331
  22.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethiopia Number Analyzed 484 participants 483 participants 485 participants 1452 participants
484 483 485 1452
1.Primary Outcome
Title Recurrent Trichiasis in Tetracycline and Azithromycin Groups
Hide Description Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.
Time Frame Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Recurrence rates (expressed as person-years) in the tetracycline arm was compared with the 2 azithromycin arms combined (483+ 485= 968 participants)
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Topical tetracycline

Antibiotic:Topical tetracycline

The two azithromycin groups combined

Antibiotic: Oral Azithromycin

Overall Number of Participants Analyzed 484 968
Measure Type: Count of Participants
Unit of Measure: Participants
45
   9.3%
62
   6.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments

The log rank test was done to compare the survival rates between the tetracycline arm and the azithromycin arms combined.

The Cox proportional hazard model was used to evaluate risk factors and adjust for confounding in predicting recurrence.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .047
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.45 to 0.98
Estimation Comments [Not Specified]
2.Primary Outcome
Title Recurrent Trichiasis Between Two Azithromycin Arms
Hide Description

Recurrence 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.

Time Frame Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention1 Intervention2
Hide Arm/Group Description:
Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g)
Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g)
Overall Number of Participants Analyzed 483 485
Measure Type: Count of Participants
Unit of Measure: Participants
26
   5.4%
36
   7.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention1, Intervention2
Comments

We tried to evaluate if treating the immediate family members of the subject with oral azithromycin along with the subject had added advantage in reducing the rate of recurrent trichiasis in comparison to treating the subject alone with oral azithromycin post surgery.

The log rank test was done to compare the survival rates between the two intervention arms.The comparison results were expressed in person-years.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Surgical Failure
Hide Description The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Topical tetracycline

Antibiotic:Topical tetracycline

The two azithromycin groups combined

Antibiotic: Oral Azithromycin

Overall Number of Participants Analyzed 484 968
Measure Type: Count of Participants
Unit of Measure: Participants
12
   2.5%
20
   2.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, Intervention
Comments Surgery was considered a failure if there was trichiasis recurrence at 6 week follow-up.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.36 to 1.10
Estimation Comments Comparison group was the tetracycline group.
4.Secondary Outcome
Title Adverse Events
Hide Description At 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.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Intervention
Hide Arm/Group Description:

Topical tetracycline

Antibiotic:Topical tetracycline

The two azithromycin groups combined

Antibiotic: Oral Azithromycin

Overall Number of Participants Analyzed 484 968
Measure Type: Count of Participants
Unit of Measure: Participants
Gastrointestinal complaints/other specific illness
6
   1.2%
22
   2.3%
Ocular complaints
7
   1.4%
6
   0.6%
Time Frame 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.
Adverse Event Reporting Description

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

 
Arm/Group Title Control Intervention
Hide Arm/Group Description

Topical tetracycline

Antibiotic:Topical tetracycline

The two azithromycin groups combined

Antibiotic: Oral Azithromycin

All-Cause Mortality
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   2/484 (0.41%)   0/968 (0.00%) 
Hide Serious Adverse Events
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/484 (0.00%)   0/968 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   13/484 (2.69%)   28/968 (2.89%) 
Surgical and medical procedures     
1.5 months * [1]  6/484 (1.24%)  22/968 (2.27%) 
1.5 months * [2]  7/484 (1.45%)  6/968 (0.62%) 
*
Indicates events were collected by non-systematic assessment
[1]
Gastrointestinal or other specific illness.Events were assessed without regard to the specific Adverse Event Term.At the 1.5-month follow-up,questions were asked from subject and all his/her family members about these adverse events.Adverse.
[2]
Ocular complaints. At the 1.5-month follow-up,questions were asked from subject and all his/her family members about these adverse events.Adverse Events were assessed without regard to the specific Adverse Event Term.
1.Azithromycin administered was observed.Compliance was 100%.In tetracycline group,only 1st application of ointment was observed.Data on compliance for next 6 weeks were not collected.
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
Layout table for Results Point of Contact information
Name/Title: Sheila K West
Organization: Johns Hopkins University
Phone: 410 955 2606
EMail: shwest@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00347776    
Other Study ID Numbers: U01EY013878 ( U.S. NIH Grant/Contract )
First Submitted: July 3, 2006
First Posted: July 4, 2006
Results First Submitted: April 13, 2017
Results First Posted: August 7, 2017
Last Update Posted: August 7, 2017