Trial · NCT00347776

Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

NCT00347776, Phase 4, Completed, Johns Hopkins University; results first posted 2017-08-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia. Trials, record NCT00347776. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00347776

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
NCT number: NCT00347776
Status: Completed
Phases: Phase 4
Enrollment: 1,452 participants, actual
Lead sponsor: Johns Hopkins University
Conditions: Trichiasis
Interventions: azithromycin, topical tetracycline
First posted: 2006-07-04
Last updated: 2017-08-07
Results first posted: 2017-08-07
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Recurrent Trichiasis in Tetracycline and Azithromycin Groups	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.
Primary	Recurrent Trichiasis Between Two Azithromycin Arms	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.
Secondary	Surgical Failure	6 weeks	The surgery was considered a failure if one or more eye lashes were touching the globe of the eye of the subject.
Secondary	Adverse Events	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recurrent Trichiasis in Tetracycline and Azithromycin Groups	Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery	Recurrence rates (expressed as person-years) in the tetracycline arm was compared with the 2 azithromycin arms combined (483+ 485= 968 participants)	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Recurrent Trichiasis Between Two Azithromycin Arms	Primary outcome assessed at 2 weeks,1.5 months, 6 months and 12 months post-surgery		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Surgical Failure	6 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Events	6 weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Recurrent Trichiasis in Tetracycline and Azithromycin Groups	Control		45	Participants
Recurrent Trichiasis in Tetracycline and Azithromycin Groups	Intervention		62	Participants
Recurrent Trichiasis Between Two Azithromycin Arms	Intervention1		26	Participants
Recurrent Trichiasis Between Two Azithromycin Arms	Intervention2		36	Participants
Surgical Failure	Control		12	Participants
Surgical Failure	Intervention		20	Participants
Adverse Events	Control	Gastrointestinal complaints/other specific illness	6	Participants
Adverse Events	Intervention	Gastrointestinal complaints/other specific illness	22	Participants
Adverse Events	Control	Ocular complaints	7	Participants
Adverse Events	Intervention	Ocular complaints	6	Participants

Source ClinicalTrials.gov

Participant flow27

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
1.5 Month Follow-up	STARTED	Control	484
1.5 Month Follow-up	STARTED	Intervention 1	483
1.5 Month Follow-up	STARTED	Intervention 2	485
1.5 Month Follow-up	COMPLETED	Control	470
1.5 Month Follow-up	COMPLETED	Intervention 1	475
1.5 Month Follow-up	COMPLETED	Intervention 2	473
1.5 Month Follow-up	NOT COMPLETED	Control	14
1.5 Month Follow-up	NOT COMPLETED	Intervention 1	8
1.5 Month Follow-up	NOT COMPLETED	Intervention 2	12
6 Month Follow-up	STARTED	Control	470

1 to 10 of 27Source ClinicalTrials.gov

See all 27 participant flow

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	1.5 months	Surgical and medical procedures	Control	6	484
other	1.5 months	Surgical and medical procedures	Intervention	22	968
other	1.5 months	Surgical and medical procedures	Control	7	484
other	1.5 months	Surgical and medical procedures	Intervention	6	968

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Control	2	484
Total, all-cause mortality	Intervention	0	968
Total, other adverse events	Control	13	484
Total, other adverse events	Intervention	28	968
Total, serious adverse events	Control	0	484
Total, serious adverse events	Intervention	0	968

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16033749	BACKGROUND	PubMed
16113353	BACKGROUND	PubMed
16424528	BACKGROUND	PubMed
16534049	RESULT	PubMed
19901217	DERIVED	PubMed
21051704	DERIVED	PubMed
22159169	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01EY013878	TRIAL OF ANTIBIOTICS TO REDUCE RECURRENT TRICHIASIS	WEST, SHEILA K	JOHNS HOPKINS UNIVERSITY	NATIONAL EYE INSTITUTE	2002 to 2005

Source NIH RePORTER

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention vs Control: Surgical Failure	Trial comparisons
Intervention1 vs Intervention2: Recurrent Trichiasis Between Two Azithromycin Arms	Trial comparisons
Intervention vs Control: Recurrent Trichiasis in Tetracycline and Azithromycin Groups	Trial comparisons
Intervention vs Control: deaths from any cause	Trial comparisons
Intervention vs Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00347776

GET https://conductscience.org/api/trials/v1/NCT00347776/flow?page=2

API reference For AI assistants