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Azithromycin in Control of Trachoma II
This study has been completed.
Study NCT00286026   Information provided by University of California, San Francisco

First Received on January 31, 2006.   Last Updated on March 10, 2011   History of Changes
Results First Received: February 7, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Trachoma
Intervention: Drug: Azithromycin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period Mar-05 through Aug-07 initially in 3 villages previously studied by us 1990-95; continuing in a 2nd & 3rd round of 3 villages in an attempt to find a high prevalence of infection.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Infection prevalence amongst screened population [n=4667] too low (<7%) to enroll any individuals into study. After screening, no participants were randomized to treatment as per protocol.

Reporting Groups
  Description
Single 1 gm Dose Azithromycin Subjects residing in villages assigned to treatment arm 1 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0); treated with Azithromycin at Day 30; re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
Two 1 gm Doses Azithromycin, 30 Days Apart Subjects residing in villages assigned to treatment arm 2 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0), as well as receive initial treatment with Azithromycin; receive a second dose of Azithromycin at Day 30; re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.

Participant Flow:   Overall Study
    Single 1 gm Dose Azithromycin     Two 1 gm Doses Azithromycin, 30 Days Apart  
STARTED     0     0  
COMPLETED     0 [1]   0 [1]
NOT COMPLETED     0     0  
[1] Infection rate <7%; too low to study.



  Baseline Characteristics
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Reporting Groups
  Description
Single 1 gm Dose Azithromycin Subjects residing in villages assigned to treatment arm 1 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0); treated with Azithromycin at Day 30; re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
Two 1 gm Doses Azithromycin, 30 Days Apart Subjects residing in villages assigned to treatment arm 2 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0), as well as receive initial treatment with Azithromycin; receive a second dose of Azithromycin at Day 30; re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.

Baseline Measures
    Single 1 gm Dose Azithromycin     Two 1 gm Doses Azithromycin, 30 Days Apart     Total  
Number of Participants  
[units: participants]
 		  0     0     0  
Age  
[units: participants]
 		     
<=18 years              
Between 18 and 65 years              
>=65 years              
Age  
[units: years]
Mean ± Standard Deviation 		           
Gender  
[units: participants]
 		     
Female              
Male              
Region of Enrollment  
[units: participants]
 		     
Egypt              



  Outcome Measures

1.  Primary:   Elimination of Infection With C. Trachomatis Diagnosed by Use of a Nucleic Acid Amplification Test.   [ Time Frame: 1-year post-treatment ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Our hypothesis that two 1 gm doses of azithromycin were superior to a single dose could not be evaluated in this study due to inability to locate a population with adequate prevalence of C. trachomatis infection in children.  


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:
Mabey D, Fraser-Hurt N. Antibiotics for trachoma. Cochrane Database Syst Rev. 2002;(1):CD001860. Review. Update in: Cochrane Database Syst Rev. 2005;(2):CD001860.
Burton MJ, Frick KD, Bailey RL, Bowman RJ. Azithromycin for the treatment and control of trachoma. Expert Opin Pharmacother. 2002 Feb;3(2):113-20. Review.
Dawson CR, Schachter J. Should trachoma be treated with antibiotics? Lancet. 2002 Jan 19;359(9302):184-5. No abstract available.
Bain DL, Lietman T, Rasmussen S, Kalman S, Fan J, Lammel C, Zhang JZ, Dawson CR, Schachter J, Stephens RS. Chlamydial genovar distribution after community wide antibiotic treatment. J Infect Dis. 2001 Dec 15;184(12):1581-8. Epub 2001 Dec 3.
Pechere JC. New perspectives on macrolide antibiotics. Int J Antimicrob Agents. 2001;18 Suppl 1:S93-7. Review.
Fraser-Hurt N, Bailey RL, Cousens S, Mabey D, Faal H, Mabey DC. Efficacy of oral azithromycin versus topical tetracycline in mass treatment of endemic trachoma. Bull World Health Organ. 2001;79(7):632-40.
Tabbara KF. Trachoma: a review. J Chemother. 2001 Apr;13 Suppl 1:18-22. Review.
Treadway G. Azithromycin: a new 15-membered macrolide. Jpn J Antibiot. 2001 Feb;54 Suppl A:70-6. Review.
Bailey R, Lietman T. The SAFE strategy for the elimination of trachoma by 2020: will it work? Bull World Health Organ. 2001;79(3):233-6. Epub 2003 Jul 7. Review.
Frick KD, Lietman TM, Holm SO, Jha HC, Chaudhary JS, Bhatta RC. Cost-effectiveness of trachoma control measures: comparing targeted household treatment and mass treatment of children. Bull World Health Organ. 2001;79(3):201-7. Epub 2003 Jul 7.
Holm SO, Jha HC, Bhatta RC, Chaudhary JS, Thapa BB, Davis D, Pokhrel RP, Yinghui M, Zegans M, Schachter J, Frick KD, Tapert L, Lietman TM. Comparison of two azithromycin distribution strategies for controlling trachoma in Nepal. Bull World Health Organ. 2001;79(3):194-200. Epub 2003 Jul 7.
Lietman T, Fry A. Can we eliminate trachoma? Br J Ophthalmol. 2001 Apr;85(4):385-7. No abstract available.
Duran JM, Amsden GW. Azithromycin: indications for the future? Expert Opin Pharmacother. 2000 Mar;1(3):489-505. Review.
Solomon AW, Akudibillah J, Abugri P, Hagan M, Foster A, Bailey RL, Mabey DC. Pilot study of the use of community volunteers to distribute azithromycin for trachoma control in Ghana. Bull World Health Organ. 2001;79(1):8-14. Epub 2003 Nov 5.
West S. The red eye. N Engl J Med. 2000 Nov 23;343(21):1577. No abstract available.
Bowman RJ, Sillah A, Van Dehn C, Goode VM, Muquit M, Johnson GJ, Milligan P, Rowley J, Faal H, Bailey RL. Operational comparison of single-dose azithromycin and topical tetracycline for trachoma. Invest Ophthalmol Vis Sci. 2000 Dec;41(13):4074-9.
Guzey M, Aslan G, Ozardali I, Basar E, Satici A, Karadede S. Three-day course of oral azithromycin vs topical oxytetracycline/polymyxin in treatment of active endemic trachoma. Jpn J Ophthalmol. 2000 Jul-Aug;44(4):387-91.
Laming AC, Currie BJ, DiFrancesco M, Taylor HR, Mathews JD. A targeted, single-dose azithromycin strategy for trachoma. Med J Aust. 2000 Feb 21;172(4):163-6.
Chern KC, Shrestha SK, Cevallos V, Dhami HL, Tiwari P, Chern L, Whitcher JP, Lietman TM. Alterations in the conjunctival bacterial flora following a single dose of azithromycin in a trachoma endemic area. Br J Ophthalmol. 1999 Dec;83(12):1332-5.
Whitty CJ, Glasgow KW, Sadiq ST, Mabey DC, Bailey R. Impact of community-based mass treatment for trachoma with oral azithromycin on general morbidity in Gambian children. Pediatr Infect Dis J. 1999 Nov;18(11):955-8.
Mabey D, Bailey R. Eradication of trachoma worldwide. Br J Ophthalmol. 1999 Nov;83(11):1261-3. Review. No abstract available.
Dawson CR. Acceptance of Medaille d'Or du Trachome by Dr. Chandler R. Dawson M. D. Kyoto, 16 May 1978. Rev Int Trach Pathol Ocul Trop Subtrop. 1978;55(3-4):21-2, 30-1. English, French. No abstract available.
Schachter J, West SK, Mabey D, Dawson CR, Bobo L, Bailey R, Vitale S, Quinn TC, Sheta A, Sallam S, Mkocha H, Mabey D, Faal H. Azithromycin in control of trachoma. Lancet. 1999 Aug 21;354(9179):630-5.
Chidambaram JD, Alemayehu W, Melese M, Lakew T, Yi E, House J, Cevallos V, Zhou Z, Maxey K, Lee DC, Shapiro BL, Srinivasan M, Porco T, Whitcher JP, Gaynor BD, Lietman TM. Effect of a single mass antibiotic distribution on the prevalence of infectious trachoma. JAMA. 2006 Mar 8;295(10):1142-6.
West SK, Munoz B, Mkocha H, Holland MJ, Aguirre A, Solomon AW, Foster A, Bailey RL, Mabey DC. Infection with Chlamydia trachomatis after mass treatment of a trachoma hyperendemic community in Tanzania: a longitudinal study. Lancet. 2005 Oct 8;366(9493):1296-300.
Mabey D, Fraser-Hurt N, Powell C. Antibiotics for trachoma. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001860. Review.
Solomon AW, Holland MJ, Alexander ND, Massae PA, Aguirre A, Natividad-Sancho A, Molina S, Safari S, Shao JF, Courtright P, Peeling RW, West SK, Bailey RL, Foster A, Mabey DC. Mass treatment with single-dose azithromycin for trachoma. N Engl J Med. 2004 Nov 4;351(19):1962-71.


Responsible Party: Julius Schachter, PhD, Univ of CA, San Francisco
ClinicalTrials.gov Identifier: NCT00286026     History of Changes
Other Study ID Numbers: H1079-17254, 5R01AI048789
Study First Received: January 31, 2006
Results First Received: February 7, 2011
Last Updated: March 10, 2011
Health Authority: United States: Institutional Review Board





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