Chlamydia Trachomatis InfectionPhase 2MecillinamCTNCT02083276
Mecillinam for Treatment of Genital Chlamydia Infection
A Phase 2 study testing Pivmecillinamhydrochlorid in people with Chlamydia Trachomatis Infection and Chlamydial Urethritis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis infection has been macrolide antibiotics in the form of azithromycin, and alternatively tetracycline antibiotics in the form of doxycycline. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chlamydia Trachomatis Infection, Chlamydial Urethritis
- What is being tested?
- Pivmecillinamhydrochlorid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Proficient in oral and written Norwegian
- Positive NAAT in first void urine for Chlamydia trachomatis
- Negative NAAT in first void urine for Mycoplasma genitalium
- Heterosexual male
- Asymptomatic
Who cannot join
- Known allergies for mecillinam, penicillin or cephalosporines
- Metabolic anomalies of aciduric type
- Apparent underweight
- Use of mecillinam within the last two months
- Under treatment with Valproat, other anti-infective drugs, immuno-modulating medication
- In the opinion of investigator,obvious reasons why patient will fails to adhere to treatment and follow-up protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men
The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis infection has been macrolide antibiotics in the form of azithromycin, and alternatively tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg doxycycline a day. However, recent studies have reported increasing treatment failure that may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is evolving. Research regarding other bacterial species indicates a high frequency of mutation based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma genitalium infections. There has only been case reports of tetracycline resistance among human Chlamydia isolates, but a recent study suggest that there might be decreasing effectiveness also for doxycycline. Veterinaries has for several years observed increasing prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population there is promiscuous horizontal gene transfer.
If the current trend of declining cure rates continues, the investigators might face a situation where there are no documented and effective treatments for Chlamydia trachomatis infections. This underline an urgent need to expand the number of documented treatment options and mecillinam seems to be one of the options that warrant further investigation.
The objectives of this study is to prove the concept of treating genital Chlamydia trachomatis with mecillinam (Pivmecillinamhydrochlorid).
- Being tested
- Pivmecillinamhydrochlorid
- Keywords
- Chlamydia trachomatis, Urethritis, Genital Diseases, Male
- Medical subject headings
- Urethritis, Genital Diseases, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PivmecillinamhydrochloridDrug
Also called Selexid
PO 400 mg x3 for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Pivmecillinamhydrochlorid | Experimental | Selexid 400 mg x 3 , 7 days Receives: Drug: Pivmecillinamhydrochlorid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest)
Measured: 3 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionMay 2015
Why it stopped: Treatment failure on study medication observed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chlamydia Trachomatis InfectionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Møre og Romsdal Hospital Trust
- Responsible party
- Principal investigator, Anne Olaug Olsen, Oslo University Hospital
- Investigators
- Anne Olaug Olsen, MD, PhD, Principal investigator, Oslo UniversityHospital , Olafia Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083276
- Sponsor's protocol ID
- 2013/1917
- Other IDs
- 2013-002379-17
- Acronym
- MecillinamCT
- Status last verified
- Jun 2015
- First submitted
- 5 Mar 2014
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Nilsen E, Aasterod M, Hustad PS, Olsen AO. Mecillinam against genital Chlamydia trachomatis infection: a small-scale proof-of-concept study shows a low cure rate. J Antimicrob Chemother. 2016 Aug;71(8):2270-2. doi: 10.1093/jac/dkw134. Epub 2016 May 10.
PubMed 27165786
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mecillinam for Treatment of Genital Chlamydia Infection in Asymptomatic Men
- ClinicalTrials.gov ID
- NCT02083276
- Acronym / sponsor ID
- MecillinamCT / 2013/1917
- Keywords
- Chlamydia trachomatis, Urethritis, Genital Diseases, Male
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment failure on study medication observed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Møre og Romsdal Hospital Trust
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The mainstay of treating both symptomatic and asymptomatic genital Chlamydia trachomatis infection has been macrolide antibiotics in the form of azithromycin, and alternatively tetracycline antibiotics in the form of doxycycline. Studies from the late nineties found a single dose of 1 g azithromycin to be equally effective as a 7 day course of 200 mg doxycycline a day. However, recent studies have reported increasing treatment failure that may indicate that resistance to macrolide antibiotics among Chlamydia trachomatis is evolving. Research regarding other bacterial species indicates a high frequency of mutation based resistance in conjunction with azithromycin use, i.e. when treating Mycoplasma genitalium infections. There has only been case reports of tetracycline resistance among human Chlamydia isolates, but a recent study suggest that there might be decreasing effectiveness also for doxycycline. Veterinaries has for several years observed increasing prevalence of tetracycline resistance among Chlamydia suis. Within the Chlamydia population there is promiscuous horizontal gene transfer.
If the current trend of declining cure rates continues, the investigators might face a situation where there are no documented and effective treatments for Chlamydia trachomatis infections. This underline an urgent need to expand the number of documented treatment options and mecillinam seems to be one of the options that warrant further investigation.
The objectives of this study is to prove the concept of treating genital Chlamydia trachomatis with mecillinam (Pivmecillinamhydrochlorid).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pivmecillinamhydrochlorid | Experimental | Drug: PivmecillinamhydrochloridSelexid 400 mg x 3 , 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Proficient in oral and written Norwegian
- Positive NAAT in first void urine for Chlamydia trachomatis
- Negative NAAT in first void urine for Mycoplasma genitalium
- Heterosexual male
- Asymptomatic
Key exclusion criteria (6 listed)
- Known allergies for mecillinam, penicillin or cephalosporines
- Metabolic anomalies of aciduric type
- Apparent underweight
- Use of mecillinam within the last two months
- Under treatment with Valproat, other anti-infective drugs, immuno-modulating medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PivmecillinamhydrochloridAlso: SelexidPO 400 mg x3 for 7 days | Drug | Pivmecillinamhydrochlorid |
Primary outcome
Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest)
Time frame: 3 weeks after end of treatment
Results and safety
The study was stopped early (reason given: Treatment failure on study medication observed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Derived from this study: PubMed 27165786Nilsen E, Aasterod M, Hustad PS, Olsen AO. Mecillinam against genital Chlamydia trachomatis infection: a small-scale proof-of-concept study shows a low cure rate. J Antimicrob Chemother. 2016 Aug;71(8):2270-2. doi: 10.1093/jac/dkw134. Epub 2016 May 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Olaug Olsen, MD, PhD principal investigator
Oslo UniversityHospital , Olafia Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pivmecillinamhydrochlorid in people with Chlamydia Trachomatis Infection and Chlamydial Urethritis, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Treatment failure on study medication observed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative control test for Chlamydia in urine (NAAT; Nucleic Acid AmplificationTest) (time frame: 3 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.