Table 2.
Mycoplasma genitalium and Clinical Treatment
| Citation | Study design | Study population | Outcome definitionsa | Treatment regimen | Reported findings |
| Horner et al, 1993 [6] | Case series | 98 M. genitalium–positive British men with NGU attending STD clinic; aged 19–53 years | Microbiologic failure; follow-up (10–21 days) | Doxycycline (200 milligrams stat plus 100 mg/d × 13 days) | 4/14 (29%) had microbiologic failure |
| Gambini et al, 2000 [12] | Cohort | 52 M. genitalium–positive Italian men with NGU attending STD clinic; aged 17–70 years | Microbiologic failure; clinical failure; follow-up (7 days) | Doxycycline (200 mg/d × 7 days) or Azithromycin (1 gram stat) Failures: received alternate treatment regimen | Doxycycline: 2/35 (6%) had clinical and microbiologic failure Azithromycin: 3/17 (18%) had clinical and microbiologic failure Failures: 0/5 (0%) had clinical or microbiologic failure |
| Johannisson et al, 2000 [13] | Case series | 21 M. genitalium–positive Swedish men with urethritis (n = 18) and women (n = 3) attending STD clinics; aged 18–60 years | Microbiologic failure; clinical failure; follow-up (3–4 weeks) | Tetracycline (0.5 grams 2×/day × 10 days) | Tetracycline in men: 8/13 (61%) had microbiologic failure; 6/13 (46%) had clinical failure Women: 1/1 (100%) had microbiologic failure |
| Horner et al, 2001 [16] | Cohort | 109 M. genitalium–positive British men with NGU attending STD clinic; age range NR | Clinical failure; follow-up (2, 6, 12 weeks) | Doxycycline (200 milligrams stat plus 100 milligrams/days × 13 days) or Erythromycin (500 milligrams 4×/day × 14 days) Persistent urethritis: Erythromycin (500 milligrams 4×/day × 14 days) plus metronidazole (400 milligrams 2×/day × 5 days) | Doxycycline-erythromycin (combined): 7/7 (100%) had clinical failure |
| Maeda et al, 2001 [40] | Cohort | 12 M. genitalium–positive Japanese men with NGU attending urology clinic; aged 17–69 years | Microbiologic failure; clinical failure; follow-up (14 days) | Levofloxacin (100 milligrams 3×/day × 14 days) | Levofloxacin: 8/12 (67%) had microbiologic and 1/12 (8%) had clinical failure 5/7 (71%) with microbiologic failure but clinical cure had recurrent NGU at 4 weeks |
| Falk et al, 2003 [85] | Cohort | 60 M. genitalium–positive Swedish men (n = 34) and women (n = 26) attending STD clinic; age range NR | Microbiologic failure; follow-up (4–5 weeks) | Doxycycline (200 milligrams stat plus 100 milligrams × 8 days) or Lymecycline (300 miligrams 2×/day × 10 days) Asymptomatic M. genitalium–positive: azithromycin (500 milligrams stat plus 250 mg/d × 4 days) | Doxycycline-lymecycline (combined): 10/16 men (63%) and 10/14 women (71%) had microbiologic failure Azithromycin: 0/8 men and women (0%) had microbiologic failure |
| Dupin et al, 2003 [20] | Cohort | 9 M. genitalium–positive French men with urethritis attending STD clinic; age range NR | Microbiologic failure; clinical failure; follow-up (15–28 days) | Doxycycline (100 mg/d × 7 days) or Minocycline (100 mg/d × 7 days) or Spectinomycin (2 grams) and minocycline (100 mg/d × 7 days) | Doxycycline: 1/1 (100%) had microbiologic and clinical failure Minocycline: 4/7 (57%) had microbiologic and 2/7 (29%) had clinical failure Spectinomycin-minocycline: 0/1 (0%) had microbiologic or clinic failure |
| Bradshaw et al, 2006 [41] | Case series | 34 M. genitalium–positive Australian men with NGU attending STD clinic; aged 22–54 years | Microbiologic failure; clinical failure; follow-up (1 month) | Azithromycin (1 gram stat) Failures: Azithromycin (1 gram weekly × 3) Azithromycin failures: moxifloxacin (400 milligrams 2×/days × 10 days) | Azithromycin (stat): 9/32 (28%) had microbiologic failure, and 8/32 (25%) had partial clinical failure and recurrence Azithromycin (weekly): 3/3 (100%) had microbiologic failure Moxifloxacin: 0/9 (0%) had microbiologic failure |
| Wikstrom et al, 2006 [53] | Cohort | 38 M. genitalium–positive Swedish men with persistent urethritis (n = 32) and female partners (n = 6) attending STD clinic, initially treated with doxycycline (200 milligrams stat plus 100 mg/d × 8 days); aged 19–47 years | Microbiologic failure; clinical failure; follow-up (3 weeks) | Azithromycin (1 gram stat or 500 milligrams stat plus 250 mg/d × 4 days) or Erythromycin (500 milligrams 2x/d × 10 days) Female partners: azithromycin (1.5 gram × 5 days) | Azithromycin: 0/20 (0%) of men had microbiologic and 2/20 (10%) had clinical failure; 0/4 (0%) women had microbiologic failure; clinical failure NR Erythromycin: 3/5 (60%) of men had microbiologic and 9/11 (82%) had clinical failure |
| Ross et al, 2006 [88] | Randomized double-blind multisite controlled trial | 4 M. genitalium–positive European and South African women with PID; age range NR | Microbiologic failure; follow-up (5–24 and 28–42 days) | Moxifloxacin (400 mg/d × 14 days) or Ofloxacin (400 milligrams 2×/day) plus metronidazole (500 milligrams 2×/day × 14 days) | Moxifloxacin: 0/3 (0%) had microbiologic failure Ofloxacin-metronidazole: 0/1 (0%) had microbiologic failure |
| Stamm et al, 2007 [42] | Randomized double-blind multisite controlled trial | 42 M. genitalium–positive US men with NGU attending STD clinics; aged 18–45 years | Microbiologic failure; clinical failure; follow-up (5 weeks) | Rifalazil (2.5, 12.5, or 25 milligrams stat) or Azithromycin (1 gram stat) | Rifalazil, 2.5 milligrams: 5/5 (100%) had microbiologic and 6/8 (75%) had clinical failure Rifalazil,12.5 milligrams: 7/7 (100%) had microbiologic and 8/8 (100%) had clinical failure Rifalazil, 25 milligrams: 5/5 (100%) had microbiologic and 3/5 (60%) had clinical failure Azithromycin: 1/7 (14%) had microbiologic and clinical failure |
| Haggerty et al, 2008 [68] | Cohort | 88 M. genitalium–positive US girls and women with PID attending outpatient clinics; aged 14–37 years | Microbiologic failure; clinical failure; follow-up (30 days) | Inpatient: cefoxitin (2 gram parenterally every 6 hours) plus Doxycycline (100 milligrams 2×/day × 14 days) Outpatient: Cefoxitin (2 gram intramuscular) plus Probenecid (1 gram) plus Doxycycline (100 milligrams 2×/day × 14 days) | Endometrium and/or cervix: 23/56 (41%) had microbiologic failure Endometrium: 14/32 (44%) had microbiologic failure Greater likelihood of clinical failure among women with M. genitalium in the endometrium (adjusted relative risk, 4.6; 95% CI 1.1–20.1) |
| Björnelius et al, 2008 [44] | Cohort | 159 M. genitalium–positive Norwegian and Swedish men with urethritis (n = 115) and women with cervicitis (n = 44) attending STD clinics; aged 18–61 years | Microbiologic failure; clinical failure; follow-up (20–56 days) | Doxycycline (200 milligrams stat plus 100 milligrams × 8 days) or Azithromycin (1 gram stat) Doxycycline failures: Extended Azithromycin (500 milligrams stat plus 250 milligrams × 4 days); Azithromycin failures: extended doxycycline (100 milligrams 2×/ day× 15 days) | Doxycycline: 63/76 (83%) of men and 17/27 (63%) of women had microbiologic failure; 54/75 (72%) of men had persisting signs and 45/67 (67%) had persisting symptoms, and 15/20 (75%) of women had clinical failure Azithromycin: 6/39 (15%) of men and 2/17 (12%) of women had microbiologic failure; 20/37 (54%) of men and 5/8 (63%) of women had persisting signs; 7/31 (23%) of men and 6/10 (60%) of women had persisting symptoms Extended Azithromycin: 2/47 (4%) of men and 0/6 (0%) of women had microbiologic failure Extended Doxycycline: 1/3 men (33%) and 1/1 woman (100%) had microbiologic failure |
| Jernberg et al, 2008 [87] | Cohort | 452 M. genitalium–positive Norwegian men with NGU (n = 234) and women with cervicitis (n = 218) attending STD clinics; age range NR | Microbiologic failure; follow-up (4–5 weeks) | Azithromycin (1 gram stat) or Azithromycin (1 gram stat plus 1 gram stat 5–7 days after 1st dose) or Ofloxacin (200 milligrams 2×/day × 10 days) or Moxifloxacin (400 milligrams × 7 days) Asymptomatic M. genitalium–positive: Azithromycin (500 milligrams plus 250 milligrams × 4 days) | Azithromycin, 1 gram: 39/183 (21%) had microbiologic failure Aazithromycin, 1 gram × 2: 10/38 (26%) had microbiologic failure Azithromycin for asymptomatic patients: 22/98 (22%) had microbiologic failure Ofloxacin: 5/9 (55%) had microbiologic failure Moxifloxacin: 0/3 (0%) had microbiologic failure |
| Bradshaw et al, 2008 [43] | Cohort | 120 M. genitalium–positive Australian men with urethritis (n = 102) and women with cervicitis (n = 18) attending STD clinic; age range NR | Microbiologic failure; follow-up (1 month) | Azithromycin (1 gram stat) Failures: moxifloxacin (400 milligrams × 10 days) | Azithromycin: 19/120 (16%) had microbiologic failure Moxifloxacin: 0/11 (0%) had microbiologic failure |
| Mena et al, 2009 [45] | Randomized trial | 78 M. genitalium–positive US men with NGU attending STD clinic; age range NR | Microbiologic failure; clinical failure; follow-up (1st: 10–17 days; 2nd: 31–41 days) | Azithromycin (1 gram stat) or Doxycycline (100 milligrams 2×/day × 7 days) Failures: Extended Azithromycin (500 milligrams stat plus 250 mg/d × 4 days) | Azithromycin: 3/23 (13%) had microbiologic and 6/23 (26%) had clinical failure Doxycycline: 17/31 (55%) had microbiologic and 10/31 (20%) had clinical failure Extended azithromycin: 2/5 (40%) had microbiologic and 1/5 (20%) had clinical failure |
| Schwebke et al, 2011 [86] | Randomized trial (double-blind) | 54 M. genitalium–positive US men attending 4 urban STD clinics; aged 16–45 years | Microbiologic failureb; follow-up (1st: 15–19 days; 2nd: 35–40 days) | Azithromycin (1 g stat; with or without tinidazole) or Doxycycline (100 milligrams 2×/d × 7 days with or without tinidazole) | Azithromycin: 15/45 (33.3%) had microbiologic failure; clinical failure NR Doxycycline: 27/39 (69.2%) had microbiologic failure; clinical failure NR |
| Takahashi et al, 2011 [89] | Cohort | 4 M. genitalium–positive Japanese men attending urology clinics; aged ≥18 years | Microbiologic failure; clinical failure; follow-up (1–3 weeks) | Levofloxacin (500 milligrams × 7 days) | Levofloxacin: 2/5 (40%) had microbiologic and 2/4 (50%) had clinical failure |
| Hamasuna et al, 2011 [90] | Cohort | 18 M. genitalium–positive Japanese outpatient men; aged ≥20 years | Microbiologic failure; clinical failure; follow-up (2–3 weeks) | Gatifloxacin (200 milligrams 2×/day × 7 days) | Gatifloxacin: 3/18 (17%) had microbiologic and 0/43 (0%) had clinical failure |
Abbreviations: NGU, nongonococcal urethritis; NR, not reported; PID, pelvic inflammatory disease; STD, sexually transmitted disease.
a
Except where otherwise noted, microbiologic failure was defined as detection of DNA by means of polymerase chain reaction in urine, urethral or cervical swab samples, or biopsy specimens at follow-up. Clinical failure was defined as partial clinical response to therapy [12], signs at follow-up [13], signs and/or symptoms at follow-up [16, 44], symptoms at follow-up [20, 40, 53, 90], ≥5 polymorphonuclear (PMN) leukocytes/high-power field (HPF) at follow-up [41, 89], persistent symptoms or ≥5 PMN leukocytes/HPF at follow-up [42], continued endometritis and pelvic pain at follow-up [68], or symptoms and/or discharge at examination plus ≥5 PMN leukocytes/HPF at follow-up [45].
b
In this study, microbiologic failure was defined as detection of RNA by Transcription Mediated Amplification in urine at follow-up.