title: A cohort study of Chlamydia trachomatis treatment failure in women: a study protocol.
abstract: BACKGROUND
  Chlamydia trachomatis is the most commonly diagnosed bacterial sexually transmitted infection in the developed world and diagnosis rates have increased dramatically over the last decade. Repeat infections of chlamydia are very common and may represent re-infection from an untreated partner or treatment failure. The aim of this cohort study is to estimate the proportion of women infected with chlamydia who experience treatment failure after treatment with 1 gram azithromycin.
  
  
  METHODS
  This cohort study will follow women diagnosed with chlamydia for up to 56 days post treatment. Women will provide weekly genital specimens for further assay. The primary outcome is the proportion of women who are classified as having treatment failure 28, 42 or 56 days after recruitment. Comprehensive sexual behavior data collection and the detection of Y chromosome DNA and high discriminatory chlamydial genotyping will be used to differentiate between chlamydia re-infection and treatment failure. Azithromycin levels in high-vaginal specimens will be measured using a validated liquid chromatography-tandem mass spectrometry method to assess whether poor azithromycin absorption could be a cause of treatment failure. Chlamydia culture and minimal inhibitory concentrations will be performed to further characterize the chlamydia infections.
  
  
  CONCLUSIONS
  Distinguishing between treatment failure and re-infection is important in order to refine treatment recommendations and focus infection control mechanisms. If a large proportion of repeat chlamydia infections are due to antibiotic treatment failure, then international recommendations on chlamydia treatment may need to be re-evaluated. If most are re-infections, then strategies to expedite partner treatment are necessary.
authors: Jane S
authors: JS
authors: Hocking
authors: Lenka A
authors: LA
authors: Vodstrcil
authors: Wilhelmina M
authors: WM
authors: Huston
authors: Peter
authors: P
authors: Timms
authors: Marcus Y
authors: MY
authors: Chen
authors: Karen
authors: K
authors: Worthington
authors: Ruthy
authors: R
authors: McIver
authors: Sepehr N
authors: SN
authors: Tabrizi
mesh_terms: D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017963:Azithromycin / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002690:Chlamydia Infections / Q000188:drug therapy* / Q000378:metabolism; D002692:Chlamydia trachomatis / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification*; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008826:Microbial Sensitivity Tests; D012725:Sexual Behavior; D017211:Treatment Failure; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D017963:Azithromycin
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