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Trial record 1 of 1 for:    7704921 [PUBMED-IDS]
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Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger

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ClinicalTrials.gov Identifier: NCT00618449
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Trachoma
Chlamydia Trachomatis
Interventions Drug: Azithromcyin
Drug: Azithromycin
Enrollment 1139

Recruitment Details Recruitment period Jan-08 thru May-09 in ten villages within the Maradi Region of Niger with high prevalence of clinically active trachoma amongst children<= age 10.
Pre-assignment Details  
Arm/Group Title Two-doses of Azithromycin Single-dose Azithromcyin
Hide Arm/Group Description Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360. Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
Period Title: Overall Study
Started 679 668
1-month, Post-treatment 666 656
1-year, Post-treatment 581 558
Completed 581 558
Not Completed 98 110
Reason Not Completed
Lost to Follow-up             98             110
Arm/Group Title Two-doses of Azithromycin Single-dose Azithromcyin Total
Hide Arm/Group Description Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360. Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360. Total of all reporting groups
Overall Number of Baseline Participants 679 668 1347
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 679 participants 668 participants 1347 participants
18.47  (17.77) 19.25  (18.66) 18.86  (18.22)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 679 participants 668 participants 1347 participants
<=10 years 350 345 695
Between 11 and 65 years 313 309 622
>=65 years 16 14 30
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 679 participants 668 participants 1347 participants
Female
352
  51.8%
354
  53.0%
706
  52.4%
Male
327
  48.2%
314
  47.0%
641
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Niger Number Analyzed 679 participants 668 participants 1347 participants
679 668 1347
1.Primary Outcome
Title Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]
Hide Description [Not Specified]
Time Frame 1-year post-treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per protocol.
Arm/Group Title Two-doses of Azithromycin Single-dose Azithromcyin
Hide Arm/Group Description:
Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
Overall Number of Participants Analyzed 679 668
Measure Type: Number
Unit of Measure: Participants
Baseline, Day-0 57 42
1-month, post-treatment 5 3
1-year, post treatment 19 12
Time Frame January 2008 thru August 2009
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Two-doses of Azithromycin Single-dose Azithromcyin
Hide Arm/Group Description Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360. Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
All-Cause Mortality
Two-doses of Azithromycin Single-dose Azithromcyin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Two-doses of Azithromycin Single-dose Azithromcyin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/581 (0.00%)   0/558 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Two-doses of Azithromycin Single-dose Azithromcyin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/581 (0.00%)   0/558 (0.00%) 
Prevalence of infection in communities was less than predicted, as was return of infection post-treatment, thus hypothesis could not be evaluated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Julius Schachter, PhD / Emeritus Professor of Laboratory Medicine
Organization: University of California, San Francisco
Phone: +1 (415) 824-5115
Publications:
Dawson CR, Jones BR, Tarizzo ML. A Guide to Trachoma Control. Geneva: World Health Organization; 1981.
World Health Organization. Future Approaches to Trachoma Control. Report of a global scientific meeting. 17 - 20 June 1996.
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00618449     History of Changes
Other Study ID Numbers: H1079-31932
5R01AI048789 ( U.S. NIH Grant/Contract )
First Submitted: February 6, 2008
First Posted: February 20, 2008
Results First Submitted: January 27, 2011
Results First Posted: May 8, 2012
Last Update Posted: May 8, 2012