An interventional study of Surveillance and treatment with azithromycin of newcomer and traveler families and Usual care in Trachoma, sponsored by Johns Hopkins University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-10-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
39 studies on the registry are indexed under Trachoma; 3 are open to participants now.
This study's enrollment of 52 is below the median of 1,300 across 31 interventional studies indexed under Trachoma.
Browse Trachoma studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Census and Mass Drug Administration (MDA): All persons residing in the 52 study communities will be eligible for both the census and the annual mass azithromycin administrations.
Intervention: In the 26 intervention communities, active surveillance for new families and returning travelers will be undertaken, and those meeting the criteria below will be eligible for family treatment with azithromycin if:
Families are "newcomers" and
Families are classified as having traveled and
Sentinel Children: In all 52 communities, samples of 135 children will be selected from the community census lists every six months for survey and examination.
These children:
Adult Women: In all 52 communities, samples of 100 women will be selected from the baseline community census list.
These women:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. 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. In addition, surveillance and treatment with azithromycin of newcomer and traveler families within 2 weeks of arrival to or return to the community.
Other: Surveillance and treatment with azithromycin of newcomer and traveler families · Other: Usual care
Communities will receive usual care, including annual mass drug administration with azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. 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.
Other: Usual care
The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration
Also known as: Zithromax
Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. 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.
Also known as: Zithromax
The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below
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
Time frame: 24 months
The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below
Time frame: 24 months
The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms.
Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center. If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval.
Time frame: Baseline only
| Milestone | Intervention | Usual Care |
|---|---|---|
| Started | NA | NA |
| Completed | NA | NA |
| Not completed | NA | NA |
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
| community | Intervention | Usual Care |
|---|---|---|
| The Proportion of Communities With C. Trachomatis Infection Prevalence of 1% or Below | 7 | 4 |
| community | Intervention | Usual Care |
|---|---|---|
| The Proportion of Communities With Clinical Trachoma Prevalence of 5% or Below | 21 | 20 |
Model the risk of active trachoma in intervention and control communities. We used the mean % and 95 % confidence interval as they present for a variable to describe the center of the population the sample represents and the precision of the estimate of that center. If the variable is normally distributed in the population, the probability is 95% that the true mean falls in the 95% confidence interval.
| community | Intervention | Usual Care |
|---|---|---|
| The Mean of the Prevalence of Active Trachoma (TF) in Communities in Both Arms. | 5.2 (3.7 to 6.6) | 4.9 (3.2 to 6.5) |
Collected over Adverse event data were collected for 24 months. The Community Health Workers collected data on adverse events after each newcomer and traveler family was identified and treated.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Usual Care | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
We collected and analyzed data on community level. Age and sex were not part of final analysis.
| Age, Customized(community) | Intervention | Usual Care | Total |
|---|---|---|---|
| Age not analyzed at community level | NA | NA | NA |
| Sex: Female, Male(community) | Intervention | Usual Care | Total |
|---|---|---|---|
| Female | NA | NA | NA |
| Male | NA | NA | NA |
| Race and Ethnicity Not Collected(Participants) | Intervention | Usual Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(community) | Intervention | Usual Care | Total |
|---|---|---|---|
| Tanzania | 26 | 26 | 52 |
Plan to share: Yes
The record gives a start of Jan 2013, a primary completion of Dec 2015 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2017, 1 year 10 months after primary completion.
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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