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Relationship of Specific Vaginal Bacteria and Bacterial Vaginosis Treatment Failure in Women Who Have Sex with Women

Jeanne M. Marrazzo, MD, MPH; Katherine K. Thomas, MS; Tina L. Fiedler, BS; Kathleen Ringwood, MSW; and David N. Fredricks, MD
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From the University of Washington and the Fred Hutchinson Cancer Research Center, Seattle, Washington.

Acknowledgment: The authors thank the study staff, including Susan Heideke, Nancy Dorn, Lauren Asaba, and Dana Varon; Kathy Agnew for performance of Gram staining of vaginal fluid; James Hughes for valuable statistical insights; and the women who participated in the study. 3M Pharmaceuticals (St. Paul, Minnesota) provided vaginal metronidazole (Metrogel vaginal, 0.75%) for some participants.

Grant Support: By the National Institute of Allergy and Infectious Diseases (grants RO1 AI052228 [Dr. Marrazzo] and RO3 AI053250 and RO1 AI061628 [Dr. Fredricks]).

Potential Financial Conflicts of Interest:Consultancies: J.M. Marrazzo (K-V Pharmaceuticals, Mission Pharmacal). Honoraria: J.M. Marrazzo (3M).

Reproducible Research Statement:Study protocol: Available by contacting Dr. Marrazzo (e-mail, jmm2@u.washington.edu). Statistical code: Available by contacting Ms. Thomas (e-mail, kkt@u.washington.edu). Data set: Not available.

Requests for Single Reprints: Jeanne Marrazzo, MD, MPH, Harborview Medical Center, Mailbox 359931, 325 Ninth Avenue, Seattle, WA 98104; e-mail, jmm2@u.washington.edu.

Current Author Addresses: Dr. Marrazzo, Ms. Thomas, and Ms. Ringwood: Harborview Medical Center, Division of Infectious Diseases, 325 Ninth Avenue, Mailbox 359931, Seattle, WA 98104.

Ms. Fiedler and Dr. Fredricks: Fred Hutchinson Cancer Research Center, 1100 Fairview Avenue North, D3-100, Box 19024, Seattle, WA 98109-1024.

Author Contributions: Conception and design: J.M. Marrazzo, D.N. Fredricks.

Analysis and interpretation of the data: J.M. Marrazzo, K.K. Thomas, D.N. Fredricks.

Drafting of the article: J.M. Marrazzo.

Critical revision of the article for important intellectual content: J.M. Marrazzo, K.K. Thomas, D.N. Fredricks.

Final approval of the article: J.M. Marrazzo, K.K. Thomas, T.L. Fiedler, K. Ringwood, D.N. Fredricks.

Provision of study materials or patients: J.M. Marrazzo.

Statistical expertise: J.M. Marrazzo, K.K. Thomas.

Obtaining of funding: J.M. Marrazzo, D.N. Fredricks.

Administrative, technical, or logistic support: K. Ringwood.

Collection and assembly of data: T.L. Fiedler, K. Ringwood.

Ann Intern Med. 2008;149(1):20-28. doi:10.7326/0003-4819-149-1-200807010-00006
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Table 1 summarizes the characteristics of 335 women enrolled in the year-long prospective study. Two women (0.6%) had C. trachomatis infection. None had N. gonorrhoeae infection, trichomoniasis, or clinically evident genital herpes. Ninety-six women (28.7%) had bacterial vaginosis at enrollment, and an additional 35 women had bacterial vaginosis at either a routine quarterly follow-up visit (n = 28) or a self-initiated visit for vaginal symptoms (n = 7) (Figure). Of these 131 women, 120 returned for follow-up (adherence to follow-up for all participants, 92%). Median time to follow-up was 34 days (range, 21 to 78 days); 75% returned within 36 days. Of the 120 women for whom we report test-of-cure findings, 119 returned for scheduled visits and 1 returned for a self-initiated symptom visit at 42 days after treatment. The per-protocol group, who returned between 21 and 44 days, comprised 108 women. β-Globin was amplified from every vaginal sample, confirming contact of swabs with a human surface. We found no evidence of PCR inhibition in any sample that used the internal amplification control PCR assay.

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Study flow diagram.

PCR = polymerase chain reaction.

* Vaginal fluid was not available for all 120 women because posttreatment vaginal fluid collection was not instituted until approximately one third of the way through the study. Initially, vaginal fluid was selectively collected for women with suspected bacterial vaginosis at follow-up because of limited resources. Collection of vaginal fluid at the follow-up visit was later broadened to all women. Other than having bacterial vaginosis, women who had posttreatment vaginal fluid collected did not differ from those who did not according to age, race, or posttreatment sexual behavior with male or female partners.

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Summary for Patients

Factors Related to Bacterial Vaginosis That Persists or Occurs Again after Treatment in Women Who Have Sex with Women

The summary below is from the full report titled “Relationship of Specific Vaginal Bacteria and Bacterial Vaginosis Treatment Failure in Women Who Have Sex with Women.” It is in the 1 July 2008 issue of Annals of Internal Medicine (volume 149, pages 20-28). The authors are J.M. Marrazzo, K.K. Thomas, T.L. Fiedler, K. Ringwood, and D.N. Fredricks.


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