Trial record 5 of 31 for:    Open Studies | "Chlamydia Infections"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Ostergotland County Council, Sweden
Sponsor:
Collaborator:
Statens Serum Institut
Information provided by (Responsible Party):
Lars Falk, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01661985
First received: July 27, 2012
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Urethritis
Cervicitis
Genital Mycoplasma Infection
Chlamydia Trachomatis
Drug: Azithromycin
Drug: Doxycycline
Drug: lymecycline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Time to Eradication of Mycoplasma Genitalium and Chlamydia Trachomatis After Antibiotic Treatment

Resource links provided by NLM:


Further study details as provided by Ostergotland County Council, Sweden:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of patients with emerging or existing macrolide resistance against Mycoplasma genitalium during or after treatment with azithromycin [ Time Frame: One month after treatment has started ] [ Designated as safety issue: No ]
    Quantitive pcr of chlamydia and Mg is used. All Mg strains are tested for mutant genes.


Other Outcome Measures:
  • Number or rate of patients adherent regarding sampling according to the protocol [ Time Frame: One month after starting sampling ] [ Designated as safety issue: No ]
    To describe whether the subjects are adherent to the study protocol according to doing the sampling and sending the samples correctly.


Estimated Enrollment: 160
Study Start Date: February 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Drug: Azithromycin 1g
Azithromycin 1 g,single dose (per os)
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.
Other Names:
  • Zitromax
  • Azitromax
Active Comparator: Drug: Doxycycline/lymecycline 9/10days
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
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)
Other Name: Doxyferm
Drug: lymecycline
Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)
Other Name: Tetralysal 300mg
Active Comparator: Azithromycin 1.5 g
Patients not randomized but receiving the first line treatment when a confirmed Mg infection
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.
Other Names:
  • Zitromax
  • Azitromax

Detailed Description:

Mycoplasma genitalium (Mg), detected in 1980, causes a urogenital infection through sexual transmission. In contrast to Chlamydia trachomatis antibiotic resistance is common against tetracyclines and is emerging against macrolides such as azithromycin. Both antibiotics are recommended as the first line treatment of chlamydia infection. Recent published data, however, indicate that 1g azithromycin stat may be only bacteriostatic when treating chlamydia.

The consensus to date is that there should always be a test of cure in pregnant women having been treated for chlamydia and in all individuals treated for Mg.

There are no studies published, to our knowledge, where the time to eradication after antibiotic treatment commenced in Mg infection has been evaluated. The first line treatment of a confirmed Mg infection is azithromycin 1.5 g given during a period of 5 days. If macrolide resistance is plausible or confirmed moxifloxacin 400mg for 7 to 10 days is recommended.

Individuals with symptomatic urethritis or cervicitis and/or being sexual partners to individuals being treated for a suspect or confirmed Mg or CT infection were eligible. The study subjects were patients attending either of the STD-clinics in Norrköping or Västervik, Sweden. All samples were sent to Statens Serum Institut(SSI), Mycoplasma department (Jorgen Skov Jensen) for analysis.

Patients accepting enrolment with a confirmed or highly suspected Mg were receiving azithromycin 500 mg the first day and 250mg the following four days.

Patients where macrolide resistant Mg-strain infection was highly suspected received moxifloxacin 400 mg once daily for seven days.

Those subjects intended to treatment but with a lower degree of suspicion of Mg infection were randomized to either a treatment with doxycycline 200 mg the first day and 100 mg once daily the following nine days (the custom and recommendation in Sweden for treatment of chlamydia and non-specific urethritis or cervicitis) OR a treatment with azithromycin 1g as a single dose.

All participants were given test kits for 12 samples, which were to be sampled three times weekly (every second day) during four weeks starting the day after the first day of treatment. They were instructed not to have any sexual intercourse during the first week and with condom afterwards during the study period. The samples were to be sent once weekly (three samples)to SSI.The date of sampling was to be noted on the label of the tube and the attaching paper to SSI, where also any symptoms were to be noted. The results of the tests were sent to the STD-clinic who informed the patient.

The study started in February 2010 and inclusion of patients will hopefully stop in December 2012.

To date 109 patients have been enrolled.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01661985

Contacts
Contact: Lars Falk, MD PhD +46 10 103 8507 lars.falk@lio.se
Contact: Jorgen S Jensen, MD DrMedSci jsj@ssi.dk

Locations
Sweden
R&D dept of Local Health Care, Östergötland county council Recruiting
Linköping, Sweden, SE-58185
Contact: Lars Falk, MD PhD       lars.falk@lio.se   
Sponsors and Collaborators
Ostergotland County Council, Sweden
Statens Serum Institut
Investigators
Principal Investigator: Lars Falk, MD PhD Dept of Derm&Venereology Linköping University hospital
  More Information

No publications provided

Responsible Party: Lars Falk, MD PhD, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier: NCT01661985     History of Changes
Other Study ID Numbers: Ostergotland CC
Study First Received: July 27, 2012
Last Updated: August 7, 2012
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Data Inspection Board

Keywords provided by Ostergotland County Council, Sweden:
Mycoplasma genitalium
Chlamydia trachomatis
Treatment
Antibiotic resistance

Additional relevant MeSH terms:
Chlamydia Infections
Uterine Cervicitis
Pleuropneumonia
Mycoplasma Infections
Urethritis
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Urethral Diseases
Urologic Diseases
Anti-Bacterial Agents
Doxycycline
Doxycycline hyclate
Lymecycline
Azithromycin
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 23, 2014