Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Mycoplasma Genitalium Antibiotic Susceptibility and Treatment: A Randomized Double-blind Trial of the Efficacy of Azithromycin and Doxycycline for Clinical and Microbiological Cure of M. Genitalium in Men With Nongonococcal Urethritis
Brief Summary: The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis.

Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (\>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination).

Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms.

Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).


Options:
A: Arm Label: Active azithromycin+placebo doxycycline; Type: ACTIVE_COMPARATOR; Interventions: Drug: Azithromycin | Arm Label: Active doxycycline+placebo azithromycin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Doxycycline | Intervention Type: DRUG; Name: Azithromycin; Assigned to Arm(s): Active azithromycin+placebo doxycycline | Intervention Type: DRUG; Name: Doxycycline; Assigned to Arm(s): Active doxycycline+placebo azithromycin
B: Intervention Type: BEHAVIORAL; Name: home testing kit; Assigned to Arm(s): N/A
C: Arm Label: Cervarix/Engerix-B A Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Biological: Engerix-B | Arm Label: Cervarix/Engerix-B B Group; Type: EXPERIMENTAL; Interventions: Biological: Cervarix, Biological: Engerix-B | Arm Label: Engerix-B Group; Type: ACTIVE_COMPARATOR; Interventions: Biological: Engerix-B | Intervention Type: BIOLOGICAL; Name: Cervarix; Assigned to Arm(s): Cervarix/Engerix-B A Group, Cervarix/Engerix-B B Group | Intervention Type: BIOLOGICAL; Name: Engerix-B; Assigned to Arm(s): Cervarix/Engerix-B A Group, Cervarix/Engerix-B B Group, Engerix-B Group
D: Arm Label: 1 Screening; Type: EXPERIMENTAL; Interventions: Behavioral: Screening for urogenital Chlamydia trachomatis | Arm Label: 2 Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Screening for urogenital Chlamydia trachomatis; Assigned to Arm(s): 1 Screening

Answer: A