Mycoplasma genitalium M. genitalium Chlamydia trachomatis Ureaplasma urealyticum Ureaplasma parvum M. genitalium Key words µ Chlamydia trachomatis Mycoplasma genitalium C. trachomatis M. genitalium H F Cl H H N N H2N F COOH O Fig.. Sitafloxacinstructure. Neisseria gonorrhoeae M. genitalium C. trachomatis M. genitalium M. genitalium
I N. gonorrhoeae γ
Table. Observationandtestschedule Observation/Tests Informedconsent Patientbackground Compliancewithdrugadministration Sexualintercourse Symptoms Urethraldischarge Adverseevent WBCinsmear Microscopic examination a) Microbiologicaltests PCRassay b) Clinicallaboratorytests EIA c) Before Endof Testing anytime required asneeded a) N.gonorhoeae b) N.gonorhoeae,C.trachomatis,M.genitalium,M.hominis,U.urealyticum,U.parvum c) C.trachomatis 2weeks afterendof anytime anytime 4 6weeks afterendof Table2. Evaluationforcriteriaoveralclinicaleficacy in nongonococcal-chlamydialurethritis and M.genitalium-positivenongonococcalurethritis Table3. Evaluationforcriteriaoveralclinicaleficacy in M. genitalium-negative nongonococcalnonchlamydialurethritis Microbiological outcome WBCinsmear Cleared Unchanged Clinicaloutcome WBCinsmear Cleared Unchanged Eradication Persistence Excelent Moderate Cure Failure Excelent Moderate N. gonorrhoeae N. gonorrhoeae C. trachomatis M. genitalium Mycoplasma hominis Ureaplasma urealyticum Ureaplasma parvum M. genitalium M. genitalium M. genitalium
C. trachomatis M. genitalium C. trachomatis M. genitalium C. trachomatis M. genitalium M. genitalium C. trachomatis II M. genitalium M. genitalium C. trachomatis M. genitalium C. trachomatis M. genitalium M. geni-
Table4. Patientprofiles Parameter Chlamydial n= 27 M.genitaliumpositive n= M.genitalium-negative nonchlamydial n= 7 n= 35 Age(yr) Weight(kg) Complication mean±sd mean±sd No Yes 3±8 65.4±8.6 23(85.2%) 4(4.8%) 26 6. 29±9 67.±8. 5(7.4%) 2(28.6%) 3±8 65.6±8.4 29(82.9%) 6(7.%) n:numberofpatients Table5. Pathogenicmicroorganisms Diagnosis Chlamydial (n= 27) M.genitalium-positive (n= ) M.genitalium-negative nonchlamydial (n= 7) (n= 35) No.ofpatientswith pathogenicmicroorganisms C.trachomatis M.genitalium M.hominis U.urealyticum U.parvum 27(%) 27(%) 2(7.4%) 6(22.2%) 6(22.2%) 4(57.%) 3(42.9%) (4.3%) 32(9.4%) 27(77.%) 3(8.6%) 9(25.7%) 8(22.9%) n:numberofpatients Table6. Mixedinfectiontypebypathogenicmicroorganism Chlamydial M.genitalium-positive M.genitalium-negative nonchlamydial Pathogenicmicroorganisms C.trachomatis C.trachomatis+ M.genitalium C.trachomatis+ U.urealyticum C.trachomatis+ U.parvum M.genitalium+ U.parvum U.urealyticum U.parvum Patients 3 2 6 6 27 3 4 32 talium M. genitalium U. parvum M. genitalium M. genitalium M. genitalium
Table7. Overalclinicaleficacy 2weeksafterendof Excelent Moderate Overaleficacy(%) a) (95%CI) b) Chlamydial M.genitalium-positive M.genitalium-negative nonchlamydial 23(85.2%) 7(%) 4(4.8%) 27 7 85.2(7.8,98.6) (,) (,) 3(88.6%) 4(.4%) 35 88.6(78.,99.) a) (Excelent+ Moderate)/No.ofpatients b) 95%confidenceinterval M. genitalium M. genitalium C. trachomatis U. urealyticum U. parvum M. genitalium C. trachomatis C. trachomatis III C. trachomatis M. genitalium C. trachomatis M. genitalium M. genitalium M. genitalium M. genitalium µ M. genitalium C. trachomatis C. trachomatis
Table8. RelationshipbetweenthedetectionofC.trachomatisbyPCRasayandEIAandclinicaloutcome Before 2weeksafter 4 6weeksafter Endof endof endof n n Clinical Clinical Clinical n n outcome outcome outcome EIA Cure Cure Cure 22 PCR positive Failure Failure Failure positive EIA Cure 2 Cure Cure 5 8 negative Failure 6 Failure Failure EIA Cure Cure Cure PCR positive Failure Failure Failure negative EIA Cure 5 Cure 3 Cure 24 8 27 34 26 negative Failure 2 Failure 3 Failure 2 n:numberofpatients 35 35 35 26 System OrganClass b) Table9. Adversereactions Patientsevaluatedforsafety 44 Patientswithadversereaction(%) 2(27.3) 95%CI a) (4.,4.4) PreferedTerm b) Patients(%) Events Headache Nervoussystem disorders Earandlabyrinthdisorders Gastrointestinaldisorders Investigations a) 95%confidenceinterval b) MedDRA/JV.9. Vertigopositional Abdominalpain Abdominalpainupper (2.3) 2 Diarhoea 6(3.6) 6 Flatulence 9(2.5) Bloodbilirubinincreased Eosinophilcountincreased Neutrophilcountincreased 3(6.8) 3 C. trachomatis
C. trachomatis M. genitalium M. genitalium M. genitalium C. trachomatis C. trachomatis U. parvum C. trachomatis N. gonorrhoeae N. gonorrhoeae N. gonorrhoeae N. gonorrhoeae N. gonorrhoeae C. trachomatis M. genitalium N. gonorrhoeae N. gonorrhoeae
Mycoplasma genitalium Mycoplasma genitalium M. genitalium Chlamydia trachomatis Mycoplasma genitalium M. genitalium Chlamydia trachomatis Ureaplasma urealyticum Ureaplasma parvum M. genitalium