Azithromycin in Control of Trachoma II

NCT00286026 | Withdrawn Phase 4

• 2 other identifiers: H1079-172545R01AI048789
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trachoma

Keywords

Chlamydia trachomatis

Outcome Measures

Primary Outcomes (1)

• Infection with Chlamydia trachomatis diagnosed by use of NAAT

  One-year

Study Arms (2)

Arm 1

EXPERIMENTAL

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); will be treated with Azithromycin at Day 30; will be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.

Drug: Azithromycin

Arm 2

EXPERIMENTAL

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 an initial treatment with Azithromycin; will receive a second dose of Azithromycin at Day 30; will be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.

Drug: Azithromycin

Interventions

Azithromycin DRUG

1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children \> 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg. One dose vs 2 doses given 30 days apart.

Also known as: Zithromax, Zmax

Arm 1; Arm 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Person resides within a selected rural village in a trachoma-endemic area of Egypt.

You may not qualify if:

• Person does not reside in one of the three rural villages being studied.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (27)

• Mabey D, Fraser-Hurt N. Antibiotics for trachoma. Cochrane Database Syst Rev. 2002;(1):CD001860. doi: 10.1002/14651858.CD001860.

  PMID: 11869610 BACKGROUND

• 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. doi: 10.1517/14656566.3.2.113.

  PMID: 11829725 BACKGROUND

• Dawson CR, Schachter J. Should trachoma be treated with antibiotics? Lancet. 2002 Jan 19;359(9302):184-5. doi: 10.1016/S0140-6736(02)07463-9. No abstract available.

  PMID: 11812548 BACKGROUND

• 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. doi: 10.1086/324661. Epub 2001 Dec 3.

  PMID: 11740734 BACKGROUND

• Pechere JC. New perspectives on macrolide antibiotics. Int J Antimicrob Agents. 2001;18 Suppl 1:S93-7. doi: 10.1016/s0924-8579(01)00393-4.

  PMID: 11574203 BACKGROUND

• 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.

  PMID: 11477966 BACKGROUND

• Tabbara KF. Trachoma: a review. J Chemother. 2001 Apr;13 Suppl 1:18-22. doi: 10.1080/1120009x.2001.11782323.

  PMID: 11434524 BACKGROUND

• Treadway G. Azithromycin: a new 15-membered macrolide. Jpn J Antibiot. 2001 Feb;54 Suppl A:70-6.

  PMID: 11296412 BACKGROUND

• 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.

  PMID: 11285668 BACKGROUND

• 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.

  PMID: 11285663 BACKGROUND

• 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.

  PMID: 11285662 BACKGROUND

• Lietman T, Fry A. Can we eliminate trachoma? Br J Ophthalmol. 2001 Apr;85(4):385-7. doi: 10.1136/bjo.85.4.385. No abstract available.

  PMID: 11264123 BACKGROUND

• Duran JM, Amsden GW. Azithromycin: indications for the future? Expert Opin Pharmacother. 2000 Mar;1(3):489-505. doi: 10.1517/14656566.1.3.489.

  PMID: 11249533 BACKGROUND

• 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.

  PMID: 11217675 BACKGROUND

• West S. The red eye. N Engl J Med. 2000 Nov 23;343(21):1577. doi: 10.1056/NEJM200011233432117. No abstract available.

  PMID: 11184764 BACKGROUND

• Bowman RJ, Sillah A, Van Dehn C, Goode VM, Muqit MM, 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.

  PMID: 11095598 BACKGROUND

• 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. doi: 10.1016/s0021-5155(00)00167-2.

  PMID: 10974295 BACKGROUND

• 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. doi: 10.5694/j.1326-5377.2000.tb125541.x.

  PMID: 10772587 BACKGROUND

• 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. doi: 10.1136/bjo.83.12.1332.

  PMID: 10574809 BACKGROUND

• 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. doi: 10.1097/00006454-199911000-00003.

  PMID: 10571428 BACKGROUND

• Mabey D, Bailey R. Eradication of trachoma worldwide. Br J Ophthalmol. 1999 Nov;83(11):1261-3. doi: 10.1136/bjo.83.11.1261. No abstract available.

  PMID: 10535853 BACKGROUND

• 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. No abstract available. English, French.

  PMID: 33432 BACKGROUND

• 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. doi: 10.1016/S0140-6736(98)12387-5.

  PMID: 10466664 BACKGROUND

• 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. doi: 10.1001/jama.295.10.1142.

  PMID: 16522834 BACKGROUND

• 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. doi: 10.1016/S0140-6736(05)67529-0.

  PMID: 16214600 BACKGROUND

• Mabey D, Fraser-Hurt N, Powell C. Antibiotics for trachoma. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD001860. doi: 10.1002/14651858.CD001860.pub2.

  PMID: 15846624 BACKGROUND

• 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. doi: 10.1056/NEJMoa040979.

  PMID: 15525721 BACKGROUND

MeSH Terms

Conditions

Trachoma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Julius Schachter, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Chandler R Dawson, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Laboratory Medicine

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: June 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2009
• Last Updated: April 16, 2012

Record last verified: 2012-04

Locations

US (1)