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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Two-doses of Azithromycin 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.
Single-dose Azithromcyin 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.

Participant Flow:   Overall Study
    Two-doses of Azithromycin   Single-dose Azithromcyin
STARTED   679   668 
1-month, Post-treatment   666   656 
1-year, Post-treatment   581   558 
COMPLETED   581   558 
NOT COMPLETED   98   110 
Lost to Follow-up                98                110 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Two-doses of Azithromycin 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.
Single-dose Azithromcyin 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 Total of all reporting groups

Baseline Measures
   Two-doses of Azithromycin   Single-dose Azithromcyin   Total 
Overall Participants Analyzed 
[Units: Participants]
 679   668   1347 
Age 
[Units: Years]
Mean (Standard Deviation)
 18.47  (17.77)   19.25  (18.66)   18.86  (18.22) 
Age, Customized 
[Units: Participants]
     
<=10 years   350   345   695 
Between 11 and 65 years   313   309   622 
>=65 years   16   14   30 
Gender 
[Units: Participants]
     
Female   352   354   706 
Male   327   314   641 
Region of Enrollment 
[Units: Participants]
     
Niger   679   668   1347 


  Outcome Measures

1.  Primary:   Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]   [ Time Frame: 1-year post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Prevalence of infection in communities was less than predicted, as was return of infection post-treatment, thus hypothesis could not be evaluated.


  More Information

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
e-mail: Julius.Schachter@ucsf.edu


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