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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
| Project ORBIS | UNKNOWN |
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Trachoma, an ocular infection caused by C. trachomatis, is the second leading cause of blindness worldwide.Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes surgery to correct trichiasis. Despite this encouraging news, under the best of circumstances the recurrence rate of trichiasis following surgery is disappointingly high. The objective of our project is to conduct a randomized, controlled clinical trial of post-surgical antibiotic treatment, comparing oral azithromycin to topical tetracycline, for trichiasis surgical patients in Ethiopia with the goal of determining the impact of treatment on rates of trichiasis recurrence at one and two years.
A randomized clinical trial of the effectiveness of a single dose of azithromycin compared to 6 weeks of topical tetracycline, and the added benefit of family-based azithromycin treatment, in preventing recurrence of trichiasis following surgery is proposed. This will provide the evidence base to inform and change the global public health policy and the donation program policy, regarding post-surgical treatment for trichiasis patients and possibly their families.
The investigators will determine the impact of three treatment strategies following trichiasis surgery on the rate of trichiasis recurrence in the operated eye at six months and one year. A randomized clinical trial of 1425 trichiasis surgical patients will be conducted in Sodo,Ethiopia. The first group (Control Group) will receive topical tetracycline following surgery; the second group (Intervention Patient Group) will receive oral azithromycin; the third group (Intervention Family Group) will receive oral azithromycin, and all family members resident in the patient's household will also receive oral azithromycin. Data will be collected at baseline (pre-surgery) on ocular status and infection status. Data will be collected at the time of surgery on surgery-related variables and surgical and post-operative complications. Additional data will be collected on any surgical complications and early recurrence at the two-week visit when sutures will be removed. A follow up visit at two months will include data collection on recurrence and presence of ocular infection. Evaluations for trichiasis recurrence will occur again at six months and at one year post-surgery. The latter visit will also include data collection on presence of ocular infection in the surgical case, and ocular infection in household members. Evaluation of the risk of recurrence at six months and one, two, and three years within each group will be completed to determine the benefit of using azithromycin compared to topical tetracycline, and the added benefit of family-based treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | topical tetracycline |
|
| Intervention 1 | Active Comparator | oral azithromycin, single 1g dose to subject |
|
| Intervention 2 | Active Comparator | single oral azithromycin dose to subject and immediate family members |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| azithromycin | Drug | oral antibiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Trichiasis in Tetracycline and Azithromycin Groups | Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation. | Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery |
| Recurrent Trichiasis Between Two Azithromycin Arms | 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. | Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Failure | The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject. | 6 weeks |
| Adverse Events | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila K West | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16113353 | Background | Melese M, West ES, Alemayehu W, Munoz B, Worku A, Gaydos CA, West SK. Characteristics of trichiasis patients presenting for surgery in rural Ethiopia. Br J Ophthalmol. 2005 Sep;89(9):1084-8. doi: 10.1136/bjo.2005.066076. | |
| 16424528 | Background | West ES, Munoz B, Imeru A, Alemayehu W, Melese M, West SK. The association between epilation and corneal opacity among eyes with trachomatous trichiasis. Br J Ophthalmol. 2006 Feb;90(2):171-4. doi: 10.1136/bjo.2005.075390. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks |
| FG001 | Intervention 1 | Oral azithromycin,single 1g dose to subject only Antibiotic : Oral azithromycin (1 g) |
| FG002 | Intervention 2 | Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1.5 Month Follow-up |
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| |||||||||||||||||||||
| 6 Month Follow-up |
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| 12 Month Follow-up |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Topical tetracycline ointment to subject. Antibiotic: Topical tetracycline ointment administered twice daily for for 6 weeks |
| BG001 | Intervention1 | Oral azithromycin,single 1g dose to subject Antibiotic : Oral azithromycin (1 g) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent Trichiasis in Tetracycline and Azithromycin Groups | Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation. | Recurrence rates (expressed as person-years) in the tetracycline arm was compared with the 2 azithromycin arms combined (483+ 485= 968 participants) | Posted | Count of Participants | Participants | Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Topical tetracycline Antibiotic:Topical tetracycline | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 1.5 months | Surgical and medical procedures | Non-systematic Assessment | 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. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheila K West | Johns Hopkins University | 410 955 2606 | shwest@jhmi.edu |
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| ID | Term |
|---|---|
| D058457 | Trichiasis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D013752 | Tetracycline |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| topical tetracycline | Drug |
|
| 6 weeks |
| 16033749 | Background | West ES, Alemayehu W, Munoz B, Melese M, Imeru A, West SK. Surgery for Trichiasis, Antibiotics to prevent Recurrence (STAR) Clinical Trial methodology. Ophthalmic Epidemiol. 2005 Aug;12(4):279-86. doi: 10.1080/09286580591005769. |
| 16534049 | Result | West SK, West ES, Alemayehu W, Melese M, Munoz B, Imeru A, Worku A, Gaydos C, Meinert CL, Quinn T. Single-dose azithromycin prevents trichiasis recurrence following surgery: randomized trial in Ethiopia. Arch Ophthalmol. 2006 Mar;124(3):309-14. doi: 10.1001/archopht.124.3.309. |
| 22159169 | Derived | Woreta F, Munoz B, Gower E, Alemayehu W, West SK. Three-year outcomes of the surgery for trichiasis, antibiotics to prevent recurrence trial. Arch Ophthalmol. 2012 Apr;130(4):427-31. doi: 10.1001/archophthalmol.2011.374. Epub 2011 Dec 12. |
| 21051704 | Derived | Gower EW, Merbs SL, Munoz BE, Kello AB, Alemayehu W, Imeru A, West SK. Rates and risk factors for unfavorable outcomes 6 weeks after trichiasis surgery. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2704-11. doi: 10.1167/iovs.10-5161. Print 2011 Apr. |
| 19901217 | Derived | Woreta TA, Munoz BE, Gower EW, Alemayehu W, West SK. Effect of trichiasis surgery on visual acuity outcomes in Ethiopia. Arch Ophthalmol. 2009 Nov;127(11):1505-10. doi: 10.1001/archophthalmol.2009.278. |
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| BG002 | Intervention2 | Oral azithromycin,single 1g dose to subject and immediate family members Antibiotic : Oral azithromycin (1 g) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
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|
|
|
| Primary | Recurrent Trichiasis Between Two Azithromycin Arms | 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. | Posted | Count of Participants | Participants | Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery |
|
|
|
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| Secondary | Surgical Failure | The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
|
| Secondary | Adverse Events | 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 484 |
| 0 |
| 484 |
| 13 |
| 484 |
| EG001 | Intervention | The two azithromycin groups combined Antibiotic: Oral Azithromycin | 0 | 968 | 0 | 968 | 28 | 968 |
|
| 1.5 months | Surgical and medical procedures | Non-systematic Assessment | 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. |
|
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| Organic Chemicals |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |