NCT01661985

Study of Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Antibiotic Treatment

Status unknown Phase 4 Last updated 12 December 2014

What this trial tests

Phase 4 trial testing Azithromycin in Urethritis in 160 participants. Status unknown.

Timeline

1 February 2010

Primary endpoint
1 August 2015

1 September 2016

Quick facts

Lead sponsor	Ostergotland County Council, Sweden
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	160
Start date	1 February 2010
Primary completion	1 August 2015
Estimated completion	1 September 2016
Sites	1 location across Sweden

Drugs / interventions tested

• Azithromycin (azithromycin) — full drug profile →
• Doxycycline (doxycycline) — full drug profile →
• lymecycline (LYMECYCLINE) — full drug profile →

Conditions studied

• Urethritis — all drugs for Urethritis →
• Cervicitis — all drugs for Cervicitis →
• Genital Mycoplasma Infection — all drugs for Genital Mycoplasma Infection →
• Chlamydia Trachomatis — all drugs for Chlamydia Trachomatis →

Sponsor

Ostergotland County Council, Sweden

Who can join

18 and older, any sex, with Urethritis or Cervicitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Time from treatment starts to date of first negative test result is achieved up to 30 days.
  Time frame: From first day of treatment to date of first negative test up to 30 days per subject
  Three arms. A randomisation (concealed envelopes) to either treatment with azithromycin 1g as a single dose or doxycycline for nine days (200 mg first day and 100 mg following nine (during summer time lymecycline 300mg twice daily for ten days). One un-randomized arm: Treatment with azithromycin 500 mg the first day and 250mg following four days or when indicated moxifloxacin 400 mg once daily for

Sponsor's own description

The purpose of this on-going study is to study the number of days after antibiotic treatment has commenced (due to infection caused by the sexually transmitted bacteria Chlamydia trachomatis (CT) and Mycoplasma genitalium(Mg)) it takes to be cured i.e to get a negative test result. The specimens are analyzed on first-catch-urine (men) or patient's self-obtained vaginal sample with quantitive nucleic acid amplification test(NAAT). A secondary aim is to detect macrolide resistant Mg-strains and study whether there are any emerging macrolide resistant Mg-strains after treatment with azithromycin. A third aim is to study whether the participating subjects are adherent to the study protocol meaning 12 samples taken during a period of four weeks.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Time to eradication of Mycoplasma genitalium after antibiotic treatment in men and women.
   Falk L, Enger M, Jensen JS. · · 2015 · cited 45× · PMID 26283670 · DOI 10.1093/jac/dkv246
2. Changes in the vaginal microbiota following antibiotic treatment for Mycoplasma genitalium, Chlamydia trachomatis and bacterial vaginosis.
   Ahrens P, Andersen LO, Lilje B, Johannesen TB, et al · · 2020 · cited 38× · PMID 32722712 · DOI 10.1371/journal.pone.0236036