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Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Treatment Commenced

NCT01661985 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Urethritis
  • Cervicitis
  • Genital Mycoplasma Infection
  • Chlamydia Trachomatis

Interventions

DRUG

Azithromycin

In the randomized arm giver orally 1 g as a single dose. In the non-randomized arm given for 5 days 250mg 2x1 first day and 1x1 following four days.

DRUG

Doxycycline

Doxycycline tablets 100 mg 2x1 the first day and 100 mg daily for following eight days (following the Swedish tradition and experience since the 1970s of treating chlamydia)

DRUG

lymecycline

Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Ostergotland County Council, Sweden

    lead OTHER

Principal Investigators

  • Lars Falk, MD PhD · Dept of Derm&Venereology Linköping University hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2015-08-31
Completion
2016-09-30

Countries

  • Sweden

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01661985 on ClinicalTrials.gov