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

NCT01661985 | Unknown Phase 4

• 1 other identifier: Ostergotland CC
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mycoplasma genitalium; Chlamydia trachomatis; Treatment; Antibiotic resistance

Outcome Measures

Primary Outcomes (1)

• Time from treatment starts to date of first negative test result is achieved up to 30 days.

  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 seven days.

  From first day of treatment to date of first negative test up to 30 days per subject

Secondary Outcomes (1)

• Number of patients with emerging or existing macrolide resistance against Mycoplasma genitalium during or after treatment with azithromycin

  One month after treatment has started

Other Outcomes (1)

• Number or rate of patients adherent regarding sampling according to the protocol

  One month after starting sampling

Study Arms (3)

Drug: Azithromycin 1g

ACTIVE COMPARATOR

Azithromycin 1 g,single dose (per os)

Drug: Azithromycin

Drug: Doxycycline/lymecycline 9/10days

ACTIVE COMPARATOR

Tetracycline either as Doxycycline or during June and July lymecycline (due to lower risk of photo-sensitivity) given for treatment in 9(10)days (per os).

Drug: Doxycycline; Drug: lymecycline

Azithromycin 1.5 g

ACTIVE COMPARATOR

Patients not randomized but receiving the first line treatment when a confirmed Mg infection

Drug: Azithromycin

Interventions

Azithromycin DRUG

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.

Also known as: Zitromax, Azitromax

Azithromycin 1.5 g; Drug: Azithromycin 1g

Doxycycline DRUG

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)

Also known as: Doxyferm

Drug: Doxycycline/lymecycline 9/10days

lymecycline DRUG

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

Also known as: Tetralysal 300mg

Drug: Doxycycline/lymecycline 9/10days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals attending the STD-clinic and being a sexual partner who has received an antibiotic treatment due to a non-specific urethritis/cervicitis or a confirmed Mycoplasma genitalium/Chlamydia trachomatis infection OR Having a confirmed infection described above or a symptomatic urethritis or cervicitis (non-gonorrhoic)

You may not qualify if:

• Allergy against any of the drugs, woman being pregnant or breast feeding, Not speaking or understanding Swedish fluently. Other medication with possible interaction to given treatment

Sponsors & Collaborators

• Ostergotland County Council, Sweden: lead
• Statens Serum Institut: collaborator

Study Sites (1)

R&D dept of Local Health Care, Östergötland county council

Linköping, SE-58185, Sweden

RECRUITING

Related Publications (1)

• Falk L, Enger M, Jensen JS. Time to eradication of Mycoplasma genitalium after antibiotic treatment in men and women. J Antimicrob Chemother. 2015 Nov;70(11):3134-40. doi: 10.1093/jac/dkv246. Epub 2015 Aug 17.

  PMID: 26283670 DERIVED

MeSH Terms

Conditions

Urethritis; Uterine Cervicitis

Interventions

Azithromycin; Doxycycline; Lymecycline

Condition Hierarchy (Ancestors)

Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Lars Falk, MD PhD

  Dept of Derm&Venereology Linköping University hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Falk, MD PhD

CONTACT

+46 10 103 8507; lars.falk@lio.se

Jorgen S Jensen, MD DrMedSci

CONTACT

jsj@ssi.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: August 10, 2012
• Study Start: February 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2016
• Last Updated: December 15, 2014

Record last verified: 2014-12

Locations

SE (1)