Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01767506 · ClinicalTrials.gov registry record · NA
A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial
A NA study of Trachoma, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT01767506: Completed NA study of Trachoma, sponsored by Johns Hopkins University.
NCT01767506 is a NA study of Trachoma that has completed, run by Johns Hopkins University. The registered enrollment target is 52 participants, below the 80,552-participant average among 4 other Trachoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01767506, a NA study of Trachoma, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on average have trachoma infection at 3.5%. The investigators plan that all communities would have annual rounds of MDA if infection is greater than 1% or follicular trachoma (TF) is 5% or more, but half would be randomized to a surveillance and treatment program to identify and treat new families and families who travel after mass treatment. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more. The proportion of communities that are able to stop mass treatment will be compared in the group of communities randomized to mass treatment plus the newcomer/traveler treatment program compared to the communities randomized to mass treatment alone after 24 months. At the recommendation of the Data Safety and Monitoring Committee in March 2015, thirty eight (38) of the 52 communities identified as being at risk of trachoma re-emergence at 18 months will be surveyed at 30 months. At risk of trachoma re-infection communities have C. trachomatis infection rates less than or equal to 1% or TF \< 5% at the time of the 18 month survey. Surveillance of communities for families that meet the newcomer or traveler status will extend 6 months beyond the 24 month survey to 30 months in the intervention communities only. A survey of sentinel children in the intervention and control communities at 30 months will be conducted to assess the level of trachoma and infection in all 38 communities at risk of trachoma re-emergence.
Primary Outcome
The proportion of communities with C. trachomatis infection prevalence at 1% or below in children ages 1 to 9 years at the 24-month survey, comparing the intervention arm to the usual practice arm
Conditions Studied
Interventions
- OTHER Usual care
- OTHER Surveillance and treatment with azithromycin of newcomer and traveler families
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-01 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01767506 record still lists
NCT01767506 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 80,552-participant average among 4 other Trachoma trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Trachoma appearing as the primary indexed condition, and to 2 interventions - of which Usual care is the first listed.
NCT01767506 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01767506 about?
NCT01767506 is a clinical study titled "A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial". Infection with C. Trachomatis has decreased substantially in trachoma endemic areas following repeated annual mass drug administration (MDA) with azithromycin, although not as rapidly as anticipated. The investigators propose to conduct a clinical trial in 52 communities in Kongwa, Tanzania that on ...
What is the current status of trial NCT01767506?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2013-01. Estimated completion is 2016-02.
What conditions does trial NCT01767506 study?
This clinical trial studies the following conditions: Trachoma.
What interventions are being tested in trial NCT01767506?
The interventions under investigation include: Usual care (OTHER), Surveillance and treatment with azithromycin of newcomer and traveler families (OTHER).
Who is sponsoring clinical trial NCT01767506?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01767506 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Trachoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Kebele Elimination of Trachoma for Ocular Health
ACTIVE NOT RECRUITING · Phase 4
-
Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania
COMPLETED · Phase 4
-
Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
COMPLETED · Phase 4
-
Impact of Water and Health Education Programs on Trachoma and Ocular C. Trachomatis in Niger
COMPLETED · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02630121 · 52 participants · Phase 4
Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea
- NCT03629171 · 52 participants · Phase 2
Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia
- NCT04128748 · 52 participants · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
- NCT04150497 · 52 participants · Phase 1
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia