Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286026
Status:
WITHDRAWN
Last Update Posted:
2012-04-16
First Post:
2006-01-31
Brief Title:
Azithromycin in Control of Trachoma II
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Azithromycin in Control of Trachoma II
Status:
WITHDRAWN
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Prevalence of infection for screened population too low 7 to enroll anyone
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Trachoma is the worlds 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 18 - 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 forand 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
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 18 - 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 forand 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
Detailed Description:
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 WHO 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 mgkg body weight in children 10 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 10 gm azithromycin while the second set of subjects will receive an initial treatment of 10 gm azithromycin followed by a second dose of 10 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 8000 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
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 WHO 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 mgkg body weight in children 10 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 10 gm azithromycin while the second set of subjects will receive an initial treatment of 10 gm azithromycin followed by a second dose of 10 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 8000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01AI048789 | NIH | None | httpsreporternihgovquickSearch5R01AI048789 |