TrachomaPhase 4PRETNCT00792922

Partnership for Rapid Elimination of Trachoma

A Phase 4 study testing Azithromycin in people with Trachoma, run by Johns Hopkins University at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages Up to 5 yearsHealthy volunteers can take part
Conditions the study is for: Trachoma
What is being tested?: Azithromycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: 3 sitesin 2 countries
Study dates: May 2008to Jun 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Communities are located in the target districts and accessible by vehicle
The community leaders consent to have the community enrolled
Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
The community size is <5,000 persons or >250 persons.
If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:
The child is age 5 years or younger

Show all 10Show fewer

The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).
The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)
The child must have an identifiable guardian capable of providing consent to participate.

Who cannot join

None listed.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Johns Hopkins University
Baltimore, Maryland, 21205
UCSF Proctor Foundation
San Francisco, California, 94143

Other trials in United States

United Kingdom1 site

London School of Hygiene and Tropical Medicine
London, WC1E 7HT

Other trials in United Kingdom

About this study

Official title: Research to Programs for Trachoma Elimination: Antibiotic Trial

Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious 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 the 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 the use of antibiotic treatment to reduce the community pool of infection with C. trachomatis. The objective of this study is to conduct a randomized, community-based trial in three countries (Niger, Tanzania and The Gambia), representing different baseline endemicities, of alternative coverages and frequencies of administration of mass antibiotic treatment as well as to determine the cost-effectiveness of these different strategies from a program perspective.

Read the detailed description

A randomized, 2x2 factorial designed trial will be implemented in each of the three countries. Communities will be randomized to two different coverage targets (80%-89% versus ≥90%) for three years of mass treatment.

In The Gambia and Tanzania, communities will be further randomized to yearly mass treatment versus mass treatment at baseline followed by yearly mass treatment only if trachoma prevalence in sentinel children is greater than 5%. The communities will continue to be followed and treatment will resume if trachoma prevalence is found to be 20% or greater at the 12 or 18 month surveys.

In Niger, communities will be randomized to the different coverage levels for annual mass azithromycin distribution and further randomized to biannual treatment at the two coverage targets for children ages twelve or younger.

Cross-sectional rates of trachoma and infection will be determined by examining sentinel children, age five years or younger, randomly selected from each community based on a community census. The census will be updated each year, and villages will be monitored at baseline, 6, 12, 18, 24, 30, and 36 months for infection and clinical disease.

The three-year study is in accord with the WHO guidelines which recommend three years of annual mass treatment followed by a re-survey to determine need for further treatment. The investigators will evaluate the efficacy of guiding further mass treatment according to a laboratory test for Chlamydia or WHO guidelines. Where investigators estimate communities have infection rates less than 5% in sentinel children, or trachomatous inflammation (TF) ( rates less than 5%, the community will be "graduated" from further mass treatment and followed for up to three years to look for evidence of re-emergent infection and disease. If rates of infection are found to be 20% or more return at the 12 or 18 month survey, mass treatment will be re-initiated.

Conditions: Trachoma
Being tested: Azithromycin
Keywords: Trachoma, Azithromycin, Mass treatment
Medical subject headings: Trachoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzithromycinDrug
Also called Zithromax
Comparison of community coverage rate
AzithromycinDrug
Also called Zithromax
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.

Study groups in NCT00792922
Study group	Role	What they receive
≥90% coverage with azithromycin target	Active comparator	Selected communities will receive mass treatment annually for three years. Receives: Drug: Azithromycin
80%-89% coverage with azithromycin target	Active comparator	Selected communities will receive mass treatment annually for three years. Receives: Drug: Azithromycin
≥90% coverage with azithromycin , treatment based	Active comparator	Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Receives: Drug: Azithromycin
80%-89% coverage with azithromycin : treatment based	Active comparator	Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.
The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.
Measured: At baseline
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma \& CT infection in Tanzania \& Gambia.
50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.
Outcomes are reported at the community level because raw data could not be accessed.
There is no way to determine how many participants were examined in each arm.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2008Jun 2014

First posted18 Nov 2008 (estimated)
Study startMay 2008
Primary completionJun 2013
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for TrachomaStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Model description: The study was a factorial study model to begin with in all 3 countries (Niger,Tanzania and Gambia) but because we never stopped treatment in Tanzania and Niger site.Hence the study design was collapsed to a simple design in Tanzania and Niger.The study model was kept as a factorial design for the Gambia site. Protocol Enrollment refers to the number of communities, not the number of participants enrolled.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00792922
Sponsor's protocol ID: NA_00018439
Acronym: PRET
Status last verified: Jun 2017
First submitted: 17 Nov 2008
Last updated: 18 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Oldenburg CE, Amza A, Cooley G, Kadri B, Nassirou B, Arnold BF, Rosenthal PJ, O'Brien KS, West SK, Bailey RL, Porco TC, Keenan JD, Lietman TM, Martin DL. Biannual versus annual mass azithromycin distribution and malaria seroepidemiology among preschool children in Niger: a sub-study of a cluster randomized trial. Malar J. 2019 Dec 3;18(1):389. doi: 10.1186/s12936-019-3033-2.
PubMed 31796025
Kim JS, Oldenburg CE, Cooley G, Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Keenan JD, Gaynor BD, Porco TC, Lietman TM, Martin DL. Community-level chlamydial serology for assessing trachoma elimination in trachoma-endemic Niger. PLoS Negl Trop Dis. 2019 Jan 28;13(1):e0007127. doi: 10.1371/journal.pntd.0007127. eCollection 2019 Jan.
PubMed 30689671
Keenan JD, Chin SA, Amza A, Kadri B, Nassirou B, Cevallos V, Cotter SY, Zhou Z, West SK, Bailey RL, Porco TC, Lietman TM; Rapid Elimination of Trachoma (PRET) Study Group. The Effect of Antibiotic Selection Pressure on the Nasopharyngeal Macrolide Resistome: A Cluster-randomized Trial. Clin Infect Dis. 2018 Nov 13;67(11):1736-1742. doi: 10.1093/cid/ciy339.
PubMed 29897440
O'Brien KS, Cotter SY, Amza A, Kadri B, Nassirou B, Stoller NE, Zhou Z, West SK, Bailey RL, Keenan JD, Porco TC, Lietman TM. Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger. Pediatr Infect Dis J. 2018 Nov;37(11):1082-1086. doi: 10.1097/INF.0000000000001992.
PubMed 29561511
Oldenburg CE, Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Porco TC, Gaynor BD, Keenan JD, Lietman TM. Comparison of Mass Azithromycin Coverage Targets of Children in Niger: A Cluster-Randomized Trachoma Trial. Am J Trop Med Hyg. 2018 Feb;98(2):389-395. doi: 10.4269/ajtmh.17-0501. Epub 2017 Dec 14.
PubMed 29260659
Oldenburg CE, Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Porco TC, Keenan JD, Lietman TM, Gaynor BD. Annual Versus Biannual Mass Azithromycin Distribution and Malaria Parasitemia During the Peak Transmission Season Among Children in Niger. Pediatr Infect Dis J. 2018 Jun;37(6):506-510. doi: 10.1097/INF.0000000000001813.
PubMed 29088030
Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Porco TC, Gaynor BD, Keenan JD, Lietman TM, Oldenburg CE. Effectiveness of expanding annual mass azithromycin distribution treatment coverage for trachoma in Niger: a cluster randomised trial. Br J Ophthalmol. 2018 May;102(5):680-686. doi: 10.1136/bjophthalmol-2017-310916. Epub 2017 Sep 11.
PubMed 28893761
Bojang E, Jafali J, Perreten V, Hart J, Harding-Esch EM, Sillah A, Mabey DC, Holland MJ, Bailey RL, Roca A, Burr SE. Short-term increase in prevalence of nasopharyngeal carriage of macrolide-resistant Staphylococcus aureus following mass drug administration with azithromycin for trachoma control. BMC Microbiol. 2017 Mar 28;17(1):75. doi: 10.1186/s12866-017-0982-x.
PubMed 28351345
Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, Zhou Z, Bailey RL, Mabey DC, Porco TC, Keenan JD, Gaynor BD, West SK, Lietman TM. A Cluster-Randomized Trial to Assess the Efficacy of Targeting Trachoma Treatment to Children. Clin Infect Dis. 2017 Mar 15;64(6):743-750. doi: 10.1093/cid/ciw810.
PubMed 27956455
Liu F, Porco TC, Amza A, Kadri B, Nassirou B, West SK, Bailey RL, Keenan JD, Lietman TM. Short-term forecasting of the prevalence of clinical trachoma: utility of including delayed recovery and tests for infection. Parasit Vectors. 2015 Oct 22;8:535. doi: 10.1186/s13071-015-1115-8.
PubMed 26489933
Liu F, Porco TC, Amza A, Kadri B, Nassirou B, West SK, Bailey RL, Keenan JD, Solomon AW, Emerson PM, Gambhir M, Lietman TM. Short-term Forecasting of the Prevalence of Trachoma: Expert Opinion, Statistical Regression, versus Transmission Models. PLoS Negl Trop Dis. 2015 Aug 24;9(8):e0004000. doi: 10.1371/journal.pntd.0004000. eCollection 2015 Aug.
PubMed 26302380
Burr SE, Hart J, Edwards T, Harding-Esch EM, Holland MJ, Mabey DC, Sillah A, Bailey RL. Anthropometric indices of Gambian children after one or three annual rounds of mass drug administration with azithromycin for trachoma control. BMC Public Health. 2014 Nov 18;14:1176. doi: 10.1186/1471-2458-14-1176.
PubMed 25407464
Gaynor BD, Amza A, Gebresailassie S, Kadri B, Nassirou B, Stoller NE, Yu SN, Cuddapah PA, Keenan JD, Lietman TM. Importance of including borderline cases in trachoma grader certification. Am J Trop Med Hyg. 2014 Sep;91(3):577-9. doi: 10.4269/ajtmh.13-0658. Epub 2014 Jul 7.
PubMed 25002297
Hart JD, Edwards T, Burr SE, Harding-Esch EM, Takaoka K, Holland MJ, Sillah A, Mabey DC, Bailey RL. Effect of azithromycin mass drug administration for trachoma on spleen rates in Gambian children. Trop Med Int Health. 2014 Feb;19(2):207-11. doi: 10.1111/tmi.12234. Epub 2014 Jan 17.
PubMed 24433194
Harding-Esch EM, Sillah A, Edwards T, Burr SE, Hart JD, Joof H, Laye M, Makalo P, Manjang A, Molina S, Sarr-Sissoho I, Quinn TC, Lietman T, Holland MJ, Mabey D, West SK, Bailey R; Partnership for Rapid Elimination of Trachoma (PRET) study group. Mass treatment with azithromycin for trachoma: when is one round enough? Results from the PRET Trial in the Gambia. PLoS Negl Trop Dis. 2013 Jun 13;7(6):e2115. doi: 10.1371/journal.pntd.0002115. Print 2013.
PubMed 23785525

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Not yet recruiting
The Effects of Hand and Face Washing With Soap on Active Trachoma Among Children 1-9 Years Old.
Active Trachoma
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Active, not recruitingPhase 4
Kebele Elimination of Trachoma for Ocular Health
Trachoma

All Trachoma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Research to Programs for Trachoma Elimination: Antibiotic Trial
ClinicalTrials.gov ID: NCT00792922
Acronym / sponsor ID: PRET / NA_00018439
Conditions: Trachoma
Keywords: Trachoma, Azithromycin, Mass treatment
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: Bill and Melinda Gates Foundation
Study start: May 2008
Primary completion: Jun 2013 (actual)
Study completion: Jun 2014 (actual)
First posted: 18 Nov 2008 (estimated)
Results: Posted 18 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4
Model description: The study was a factorial study model to begin with in all 3 countries (Niger,Tanzania and Gambia) but because we never stopped treatment in Tanzania and Niger site.Hence the study design was collapsed to a simple design in Tanzania and Niger.The study model was kept as a factorial design for the Gambia site. Protocol Enrollment refers to the number of communities, not the number of participants enrolled.

Arm	Type	Receives
≥90% coverage with azithromycin target	Active comparator	Drug: AzithromycinSelected communities will receive mass treatment annually for three years.
80%-89% coverage with azithromycin target	Active comparator	Drug: AzithromycinSelected communities will receive mass treatment annually for three years.
≥90% coverage with azithromycin , treatment based	Active comparator	Drug: AzithromycinTreatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under.
80%-89% coverage with azithromycin : treatment based	Active comparator	Drug: AzithromycinTreatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under.

Who may qualify

Ages: Up to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (10 listed)

Communities are located in the target districts and accessible by vehicle
The community leaders consent to have the community enrolled
Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
The community size is <5,000 persons or >250 persons.
If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzithromycinAlso: ZithromaxComparison of community coverage rate	Drug	80%-89% coverage with azithromycin target, ≥90% coverage with azithromycin target
AzithromycinAlso: ZithromaxComparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.	Drug	80%-89% coverage with azithromycin : treatment based, ≥90% coverage with azithromycin , treatment based

Primary outcome

Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
Time frame: At baseline
Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years. The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
Time frame: 3 years
100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma \& CT infection in Tanzania \& Gambia. 50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection. Outcomes are reported at the community level because raw data could not be accessed. There is no way to determine how many participants were examined in each arm.

Results and safety

Results posted to the registry on 18 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
≥90% Coverage With Azithromycin Target	–	–
80%-89% Coverage With Azithromycin Target	–	–
≥90% Coverage With Azithromycin , Treatment Based	–	–
80%-89% Coverage With Azithromycin : Treatment Based	–	–

Primary outcome: Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline

Time frame: At baseline. Mean (Standard Deviation). Unit: community

Measure	≥90% Coverage With Azithromycin Target n = NA	80%-89% Coverage With Azithromycin Target n = NA	≥90% Coveage With Azithromycin , Treatment Based n = NA	80%-89% Coverage With Azithromycin : Treatment Based n = NA
Prevalence of trachoma in Tanzania at baseline	30.7 (16.3)	30.3 (13.5)	31.1 (9.5)	30.5 (10.4)
C.trachomatis infection in Tanzania at baseline	24.6 (12.4)	17.8 (10.3)	23.0 (11.2)	22.4 (23.3)
prevalence of trachoma in Gambia at baseline	7.4 (26.1)	5.6 (23.1)	6.2 (24.1)	6.1 (23.8)
C.trachomatis infection in Gambia at baseline	0.9 (9.9)	0.7 (8.6)	1.2 (10.8)	0.2 (2.9)
prevalence of trachoma in Niger at baseline	28.4 (13.9)	27.0 (17.3)	23.9 (12.0)	24.7 (13.0)
C.trachomatis infection in Niger at baseline	21.9 (16.7)	20.5 (16.8)	15.6 (8.8)	24.9 (14.1)

Population analysed: At baseline 8 communities were randomized to each arm in Tanzania, 12 communities were randomized to each arm in Gambia and Niger. Stop rule could not be applied in Tanzania.Communities in stop arm were moved to ≥90% coverage or 80%-89% coverage with azithromycin target arm and only main effect of coverage was analyzed in Tanzania.

Primary outcome: Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months

Time frame: 3 years. Mean (Standard Deviation). Unit: community

Measure	≥90% Coverage With Azithromycin Target n = NA	80%-89% Coverage With Azithromycin Target n = NA	≥90% Coveage With Azithromycin, Treatment Based n = NA	80%-89% Coverage With Azithromycin: Treatment Based n = NA
Prevalence of trachoma (TF) in Tanzania at 3 years	9.0 (5.9)	6.1 (4.0)	–	–
C.trachomatis infection in Tanzania at 3 years	5.4 (3.7)	4.0 (2.7)	–	–
Prevalence of trachoma (TF) in Gambia at 3 years	3.0 (17.1)	2.3 (14.9)	3.2 (17.6)	2.5 (15.7)
C.trachomatis infection in Gambia at 3 years	0.2 (4.1)	1.0 (9.5)	0.7 (8.2)	0.2 (4.2)
Prevalence of trachoma (TF) in Niger at 3 years	8.9 (8.8)	7.1 (7.8)	5.4 (3.9)	10.1 (10.5)
C.trachomatis infection in Niger at 3 years	7.1 (6.8)	4.6 (7.9)	3.3 (3.6)	4.4 (6.0)

≥90% Coverage With Azithromycin Target vs 80%-89% Coverage With Azithromycin Target: Mean Difference (Final Values): 1.4 (95% CI -1 to 3.8), p = 0.22, Regression, Linear
80%-89% Coverage With Azithromycin Target: Mean Difference (Final Values): 2.6 (95% CI -0.3 to 5.3), p = 0.73, Ordinary least squares linear regression
≥90% Coverage With Azithromycin Target vs 80%-89% Coverage With Azithromycin Target vs ≥90% Coveage With Azithromycin, Treatment Based vs 80%-89% Coverage With Azithromycin: Treatment Based: Median Difference (Final Values): -4.6 (95% CI -11.1 to 1.9), p = 0.20, Regression, Linear

Population analysed: We analyzed and reported the results of the trial at community level.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
≥90% Coverage With Azithromycin Target	0 of 32 (0%)	0 of 32 (0%)	Not reported
80%-89% Coverage With Azithromycin Target	0 of 32 (0%)	0 of 32 (0%)	Not reported
≥90% Coverage With Azithromycin , Treatment Based	0 of 32 (0%)	0 of 32 (0%)	Not reported
80%-89% Coverage With Azithromycin : Treatment Based	0 of 32 (0%)	0 of 32 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31796025Oldenburg CE, Amza A, Cooley G, Kadri B, Nassirou B, Arnold BF, Rosenthal PJ, O'Brien KS, West SK, Bailey RL, Porco TC, Keenan JD, Lietman TM, Martin DL. Biannual versus annual mass azithromycin distribution and malaria seroepidemiology among preschool children in Niger: a sub-study of a cluster randomized trial. Malar J. 2019 Dec 3;18(1):389. doi: 10.1186/s12936-019-3033-2.
Derived from this study: PubMed 30689671Kim JS, Oldenburg CE, Cooley G, Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Keenan JD, Gaynor BD, Porco TC, Lietman TM, Martin DL. Community-level chlamydial serology for assessing trachoma elimination in trachoma-endemic Niger. PLoS Negl Trop Dis. 2019 Jan 28;13(1):e0007127. doi: 10.1371/journal.pntd.0007127. eCollection 2019 Jan.
Derived from this study: PubMed 29897440Keenan JD, Chin SA, Amza A, Kadri B, Nassirou B, Cevallos V, Cotter SY, Zhou Z, West SK, Bailey RL, Porco TC, Lietman TM; Rapid Elimination of Trachoma (PRET) Study Group. The Effect of Antibiotic Selection Pressure on the Nasopharyngeal Macrolide Resistome: A Cluster-randomized Trial. Clin Infect Dis. 2018 Nov 13;67(11):1736-1742. doi: 10.1093/cid/ciy339.
Derived from this study: PubMed 29561511O'Brien KS, Cotter SY, Amza A, Kadri B, Nassirou B, Stoller NE, Zhou Z, West SK, Bailey RL, Keenan JD, Porco TC, Lietman TM. Childhood Mortality After Mass Distribution of Azithromycin: A Secondary Analysis of the PRET Cluster-randomized Trial in Niger. Pediatr Infect Dis J. 2018 Nov;37(11):1082-1086. doi: 10.1097/INF.0000000000001992.
Derived from this study: PubMed 29260659Oldenburg CE, Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Porco TC, Gaynor BD, Keenan JD, Lietman TM. Comparison of Mass Azithromycin Coverage Targets of Children in Niger: A Cluster-Randomized Trachoma Trial. Am J Trop Med Hyg. 2018 Feb;98(2):389-395. doi: 10.4269/ajtmh.17-0501. Epub 2017 Dec 14.
Derived from this study: PubMed 29088030Oldenburg CE, Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Porco TC, Keenan JD, Lietman TM, Gaynor BD. Annual Versus Biannual Mass Azithromycin Distribution and Malaria Parasitemia During the Peak Transmission Season Among Children in Niger. Pediatr Infect Dis J. 2018 Jun;37(6):506-510. doi: 10.1097/INF.0000000000001813.
Derived from this study: PubMed 28893761Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, West SK, Bailey RL, Porco TC, Gaynor BD, Keenan JD, Lietman TM, Oldenburg CE. Effectiveness of expanding annual mass azithromycin distribution treatment coverage for trachoma in Niger: a cluster randomised trial. Br J Ophthalmol. 2018 May;102(5):680-686. doi: 10.1136/bjophthalmol-2017-310916. Epub 2017 Sep 11.
Derived from this study: PubMed 28351345Bojang E, Jafali J, Perreten V, Hart J, Harding-Esch EM, Sillah A, Mabey DC, Holland MJ, Bailey RL, Roca A, Burr SE. Short-term increase in prevalence of nasopharyngeal carriage of macrolide-resistant Staphylococcus aureus following mass drug administration with azithromycin for trachoma control. BMC Microbiol. 2017 Mar 28;17(1):75. doi: 10.1186/s12866-017-0982-x.
Derived from this study: PubMed 27956455Amza A, Kadri B, Nassirou B, Cotter SY, Stoller NE, Zhou Z, Bailey RL, Mabey DC, Porco TC, Keenan JD, Gaynor BD, West SK, Lietman TM. A Cluster-Randomized Trial to Assess the Efficacy of Targeting Trachoma Treatment to Children. Clin Infect Dis. 2017 Mar 15;64(6):743-750. doi: 10.1093/cid/ciw810.
Derived from this study: PubMed 26489933Liu F, Porco TC, Amza A, Kadri B, Nassirou B, West SK, Bailey RL, Keenan JD, Lietman TM. Short-term forecasting of the prevalence of clinical trachoma: utility of including delayed recovery and tests for infection. Parasit Vectors. 2015 Oct 22;8:535. doi: 10.1186/s13071-015-1115-8.
Derived from this study: PubMed 26302380Liu F, Porco TC, Amza A, Kadri B, Nassirou B, West SK, Bailey RL, Keenan JD, Solomon AW, Emerson PM, Gambhir M, Lietman TM. Short-term Forecasting of the Prevalence of Trachoma: Expert Opinion, Statistical Regression, versus Transmission Models. PLoS Negl Trop Dis. 2015 Aug 24;9(8):e0004000. doi: 10.1371/journal.pntd.0004000. eCollection 2015 Aug.
Derived from this study: PubMed 25407464Burr SE, Hart J, Edwards T, Harding-Esch EM, Holland MJ, Mabey DC, Sillah A, Bailey RL. Anthropometric indices of Gambian children after one or three annual rounds of mass drug administration with azithromycin for trachoma control. BMC Public Health. 2014 Nov 18;14:1176. doi: 10.1186/1471-2458-14-1176.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sheila West, PhD principal investigator

Johns Hopkins University

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Azithromycin in people with Trachoma, run by Johns Hopkins University at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00792922, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.