Trachoma Clinical Trial
Official title:
Azithromycin in Control of Trachoma II
Trachoma is the world's leading cause of preventable blindness. This disease, caused by
Chlamydia trachomatis, is endemic in many parts of the developing world. In 1990s we
evaluated the use of community-wide treatment with oral azithromycin in a project called
Azithromycin in Control of Trachoma (ACT). This approach resulted in clinical improvement
and dramatic reduction in prevalence of chlamydial infection through a 1-year follow-up. We
enrolled the ACT villages, as well as an additional village that had not had any prior
treatments, in our ACT II (2005) study and performed clinical surveys to assess trachoma
activity testing conjunctival swabs for the presence of C. trachomatis by nucleic acid
amplification tests (NAATs). Thus, we hoped to determine the long-term (10 year) effects of
azithromycin treatment.
We have completed the census and clinical survey of the initial three villages. Mass
treatment with azithromycin would not be justified with such low rates (1.8 - 4%) of ocular
chlamydial infection. We have treated only those living in households with one or more cases
of chlamydial infection and we will not follow up on these individually treated families.
In order to achieve the goals of our study, we now propose to identify other more remote
villages with trachoma infection rates of 20% or more to evaluate the effect of
community-wide treatment with single dose of oral azithromycin. If one or more of these
villages (dependent upon population) has trachoma rates of 20% or more they will be invited
to participate in the azithromycin treatment. In one set of subjects (1 or 2 villages,
dependent upon population and infection rate) we will perform treatment, and follow them up
at 2-, 12-, and 24-months post-treatment to ascertain infection rates. In a second set of
subjects (1 or 2 villages, dependent upon population and infection rate) we will perform
treatment, then perform re-treatment at 30-days post initial treatment, and follow them up
at 2-, 12-, and 24-months post-treatment to ascertain infection rates. This should help us
determine the need for/and the best time for re-treatment to eliminate blinding trachoma, as
some recent studies suggest there is a 2-4% failure rate in the initial treatment. In sum,
this study should provide a rational approach to use of community-wide azithromycin
treatment to eliminate blinding trachoma as a public health problem
This is operational research aimed at better defining the use of oral azithromycin as part
of the SAFE strategy to eliminate blinding trachoma.
1. Before the examinations, we will do a census and a sketch map of houses in each
village. Particular emphasis will be placed on identifying all the children between 1
and 6 years of age. These children are the chief reservoir of infection, and would have
been too young (or unborn) at the ACT study treatment, so it is of particular interest
to determine their disease and infection status.
2. Egyptian ophthalmologists will examine the eyelids, conjunctiva and cornea using
magnifying loupes and a hand held light, with grading following the ACT protocol which
contains categories referable to the W.H.O. detailed grading scheme. The clinical
findings will be recorded on a standardized form.
3. Egyptian health aides will photograph the inside of the right upper eyelid of all
subjects. The photographs of the subjects at the initial visit and all subsequent
examinations will be examined to confirm the consistency of clinical findings over the
period of the study.
4. To test for chlamydial infection, a single fiber-tipped swab will be stroked gently
over the conjunctiva of the right eye by an Egyptian ophthalmologist. These swabs will
be placed in special tubes and tested for Chlamydia trachomatis by a nucleic acid
amplification assay. [APTIMA® Gen-Probe Inc. (San Diego, CA.)] The APTIMA® assay
detects DNA via r-RNA by a process called transcription mediated amplification.
Laboratory testing will be performed at the Chlamydia Research Laboratory at University
of California, San Francisco.
5. After the results are obtained from the nucleic acid amplification testing performed at
the laboratory in San Francisco, treatment for trachoma will be done with a single-dose
of oral azithromycin (20 mg/kg body weight in children, 1.0 gm adults). The
azithromycin will be donated by Pfizer International. Young children will be weighed to
determine the dose of azithromycin and the doses administered by a health aide under
direct supervision of an Egyptian physician (Dr. Mahfouz). One set of subjects (1 or 2
villages depending upon population size, in order to generate meaningful numbers) will
receive an initial treatment of 1.0 gm azithromycin; while the second set of subjects
will receive an initial treatment of 1.0 gm azithromycin, followed by a second dose of
1.0 gm azithromycin at 30 days post treatment.
1. If the prevalence of clinical trachoma is over 20% in children 10 and under,
everyone in the village will be treated with oral azithromycin.
After initial azithromycin treatment, follow-up examinations and specimen
collection will be done 2, 12, and 24 months post-treatment for trachoma and
chlamydial infection.
2. If the prevalence is 10% to 20%, all children 10 and under, and the families of
those children with active trachoma, will be treated.
After initial azithromycin treatment, follow-up examinations and specimen
collection will be done 2, 12, and 24 months post-treatment for trachoma and
chlamydial infection.
3. If the prevalence is less than 10%, only children with active disease and their
families will receive treatment. There will be no follow-up examinations.
Adults and older children will be told that azithromycin can cause nausea, vomiting, or
loose stools or vomiting in some children and adults, and can occur in up to 5% (1
person in 20) of those treated.
It should be noted that in our previous ACT study, more than 8,000 people received
azithromycin with no complaints beyond minor gastro-intestinal upset.
6. All positive specimens will have the major outer membrane gene amplified and sequenced.
The genovars will be mapped for location within villages and families and then their
distribution will be followed over time, after treatment to provide a better
understanding of the epidemiology of the infection. Results of the study will be used
as data input for the generation of mathematical models to predict whether
community-wide retreatment (or alternate strategies) will be needed, and the optimal
timing for such retreatment.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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