Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia (STAR)
|ClinicalTrials.gov Identifier: NCT00347776|
Recruitment Status : Completed
First Posted : July 4, 2006
Results First Posted : August 7, 2017
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Trichiasis||Drug: azithromycin Drug: topical tetracycline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1452 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Trial of Antibiotics to Reduce Recurrent Trichiasis (STAR)|
|Study Start Date :||August 2001|
|Primary Completion Date :||December 2003|
|Study Completion Date :||December 2006|
Active Comparator: Control
|Drug: topical tetracycline|
Active Comparator: Intervention 1
oral azithromycin, single 1g dose to subject
Other Name: Zithromax
Active Comparator: Intervention 2
single oral azithromycin dose to subject and immediate family members
Other Name: Zithromax
- Recurrent Trichiasis in Tetracycline and Azithromycin Groups [ Time Frame: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery ]Recurrence of trichiasis : Clinical assessment was done by looking for one or more eye lashes touching globe or evidence of epilation.
- Recurrent Trichiasis Between Two Azithromycin Arms [ Time Frame: Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery ]
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.
- Surgical Failure [ Time Frame: 6 weeks ]The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.
- Adverse Events [ Time Frame: 6 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347776
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Sheila K West||Johns Hopkins University|