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TrachomaPhase 4NCT00347607

Study of Three Alternatives for Mass Treatment in Trachoma Villages of Tanzania

A Phase 4 study testing community surveillance and re-treatment in people with Trachoma, run by Johns Hopkins University at 2 sites in 2 countries.

Completed

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

Official record
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Trial summary

After single, yearly, mass treatment of communities with azithromycin for active trachoma, what is the added effectiveness for reduction of trachoma and ocular C. trachomatis infection at one, two, and three years, relative to the added costs, of community-based surveillance and treatment of cases of severe trachoma… Read more about this study

Who is it for?
Ages 12 months to 7 yearsHealthy volunteers can take part
Conditions the study is for
Trachoma
What is being tested?
community surveillance and re-treatment
How many people
2,700 participants
Where
2 sitesin 2 countries
Study dates
Apr 2002to Nov 2005
Phase
Phase 4
Are there results?
None posted in the registry

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 12 months to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • villages not in the Tanzania National Trachoma control Program in Kongwa, Tanzania
  • villages with population size less than 5,000
  • sentinel children: ages 1 year to 7 years

Who cannot join

  • Village leadership refuses to allow village participation
  • sentinel children: previous history of treatment with azithromycin
  • sentinel children: another family member (child)already enrolled in study

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site
  • Johns Hopkins university

    Baltimore, Maryland, 21205

Other trials in United States

Tanzania1 site
  • Kongwa Trachoma Project

    Kongwa, Dodoma

Other trials in Tanzania

About this study

Official title: Cost-effectiveness of Three Alternative Azithromycin Treatment Strategies for Trachoma Control in Tanzania

After single, yearly, mass treatment of communities with azithromycin for active trachoma, what is the added effectiveness for reduction of trachoma and ocular C. trachomatis infection at one, two, and three years, relative to the added costs, of community-based surveillance and treatment of cases of severe trachoma (TI) semi-annually or every 4 months?

Read the detailed description

An important component of a trachoma control program is the effective use of antibiotics, particularly azithromycin, to reduce the pool of chlamydial ocular infection in the communities. A reduction in the pool of infection will reduce the likelihood of transmission and, coupled with effective hygiene and environmental changes, theoretically lead to reduction in disease to the point where active trachoma is no longer a public health problem. Our previous experience with the use of azithromycin for community treatment has shown that even with high rates of coverage, hyperendemic communities will start to experience re-emergent trachoma following treatment by one year. Therefore, it is urgent to determine if there is another treatment strategy for these villages to keep the pool of infection low, and eventually eliminated.A combination approach consisting of mass treatment at yearly intervals and surveillance with a targeted treatment approach in the interim period may be effective in maintaining the low rate of re-emergent disease.We propose to test the cost-effectiveness of three alternative strategies for the frequency of provision of azithromycin, in the context of the Tanzanian National Trachoma Control Program. The strategies have been developed to build on the epidemiological knowledge of trachoma in this area, to be locally appropriate in terms of feasibility and personnel, and to be consistent with the goal of enhancing community control of the program.

A total of nine villages in the Kongwa district of Tanzania will be randomized to one of three groups (a total of three villages per group). The nine villages, with active trachoma rates in pre-school children of 50% or greater, would be slated for enrollment in the National Program, but not currently receiving treatment. Surveys for active trachoma status would be carried out in 300 randomly selected, children ages 1-7 years (pre-school)in each village at baseline, at 6 months post mass treatment, and at one, two, and three years post baseline. The following treatment strategies will be used:

Control villages: Usual practice: The three villages randomized to this arm would receive mass treatment of the community once a year as part of the Tanzania National Trachoma Control program.

Intervention 1. Usual practice plus community surveillance for TI cases and treatment at 6 months: The three villages randomized to this arm would receive mass treatment, similar to the usual practice arm, but in addition, would have a cadre of community volunteers, trained to recognize TI. They will screen their neighborhoods, examining all pre-school children and mothers, and arrange with the health worker for another round of treatment for TI cases and their families at 6 months, and 18 months post baseline.

Intervention 2: Usual practice plus community surveillance for TI cases and treatment every 4 months: The three villages randomized to this arm would have an approach identical to intervention 1, but with surveillance and treatment of TI cases at 4 and 8 months instead of at 6 months.For the second year, they would have surveillance and treatment at 6 months.

Cost data on the community surveillance and treatment program will be collected throughout the first year. Analyses will focus on the additional benefit on reduction in prevalence of trachoma, and ocular C. trachomatis infection, at one, two, and three years of the two alternative strategies, relative to yearly mass treatment alone, and the cost-effectiveness of the three strategies.

Conditions
Trachoma
Being tested
community surveillance and re-treatment
Keywords
trachoma, chlamydia trachomatis, surveillance, azithromycin
Medical subject headings
Trachoma

What participants receive

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

  • community surveillance and re-treatmentBehavioural

What is being measured

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

  1. trachoma

  2. ocular C. trachomatis

Timeline

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

  1. First posted4 Jul 2006 (estimated)
  2. Study startApr 2002
  3. Study completionNov 2005

Resources

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
Parallel groups
Masking
Double blind
Enrolment
2,700 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00347607
Sponsor's protocol ID
ITI01-033
Status last verified
Mar 2002
First submitted
3 Jul 2006
Last updated
28 Oct 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing community surveillance and re-treatment in people with Trachoma, run by Johns Hopkins University at 2 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 3 inclusion and 3 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 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Tanzania. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

trachoma. 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?
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 28 Oct 2011.

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