Chlamydia Trachomatis InfectionPhase 2NCT01631201
Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women
A Phase 2 study testing Rifalazil 25 milligram and Azithromycin 1 gram in people with Chlamydia Trachomatis Infection, run by ActivBiotics Pharma, LLC at 5 sites in United States.
Trial summary
This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Chlamydia Trachomatis Infection
- What is being tested?
- Rifalazil 25 milligram and Azithromycin 1 gram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2012to Apr 2013
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 19 years old diagnosed with genital chlamydia trachomatis infection.
- Use an effective method of contraception.
- Agree to be abstinent or to have partners use condoms for all sexual activities during the study.
Who cannot join
- Subject or sexual partner is known to have gonorrhea.
- History of repeated chlamydia trachomatis infection.
- HIV, syphilis, or active Hepatitis B or C infection.
- Treatment with antimicrobial therapy with known activity against chlamydia trachomatis within 4 weeks of enrollment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Research Site
Birmingham, Alabama, 35294
Research Site
Indianapolis, Indiana, 46202
Research Site
Las Vegas, Nevada, 89106
Research Site
San Diego, California, 92108
Research Site
Virginia Beach, Virginia, 23456
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Safety and Efficacy of Rifalazil (25 Milligram) Compared With Azithromycin (1 Gram) for the Treatment of Uncomplicated Genital Chlamydia Trachomatis Infection in Women
This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.
- Conditions
- Chlamydia Trachomatis Infection
- Being tested
- Rifalazil 25 milligram, Azithromycin 1 gram
- Keywords
- Chlamydia
- Medical subject headings
- Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifalazil 25 milligramDrug
Also called KRM-1648
Single dose of 25 milligram rifalazil to be administered on Day 1.
Azithromycin 1 gramDrug
Also called Zithromax
Single dose of Azithromycin 1 gram to be administered on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Rifalazil 25 milligram | Experimental | Not described Receives: Drug: Rifalazil 25 milligram |
| Azithromycin 1 gram | Active comparator | Single dose of Azithromycin 1 gram to be administered on Day 1. Receives: Drug: Azithromycin 1 gram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22
Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
Measured: Day 22
Secondary outcomes (3)
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36.
Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
Measured: Day 36
Number of subjects experiencing adverse events in the two treatment groups.
Measured: Day 36 (end of study)
Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.
Measured: Day 36 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013
- Study completionApr 2013
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- ActivBiotics Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chalom B Sayada, MD, PhD, Study director, ActivBiotics Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631201
- Sponsor's protocol ID
- APL-1648-027
- Status last verified
- Apr 2013
- First submitted
- 18 Jun 2012
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Geisler WM, Pascual ML, Mathew J, Koltun WD, Morgan F, Batteiger BE, Mayes A, Tao S, Hurwitz SJ, Sayada C, Schinazi RF. Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women. Antimicrob Agents Chemother. 2014 Jul;58(7):4014-9. doi: 10.1128/AAC.02521-14. Epub 2014 May 5.
PubMed 24798277
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Safety and Efficacy of Rifalazil (25 Milligram) Compared With Azithromycin (1 Gram) for the Treatment of Uncomplicated Genital Chlamydia Trachomatis Infection in Women
- ClinicalTrials.gov ID
- NCT01631201
- Acronym / sponsor ID
- APL-1648-027
- Conditions
- Chlamydia Trachomatis Infection
- Keywords
- Chlamydia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- ActivBiotics Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Jun 2012 (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.
This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifalazil 25 milligram | Experimental | Drug: Rifalazil 25 milligram |
| Azithromycin 1 gram | Active comparator | Drug: Azithromycin 1 gramSingle dose of Azithromycin 1 gram to be administered on Day 1. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female ≥ 19 years old diagnosed with genital chlamydia trachomatis infection.
- Use an effective method of contraception.
- Agree to be abstinent or to have partners use condoms for all sexual activities during the study.
Key exclusion criteria (4 listed)
- Subject or sexual partner is known to have gonorrhea.
- History of repeated chlamydia trachomatis infection.
- HIV, syphilis, or active Hepatitis B or C infection.
- Treatment with antimicrobial therapy with known activity against chlamydia trachomatis within 4 weeks of enrollment.
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 |
|---|---|---|
| Rifalazil 25 milligramAlso: KRM-1648Single dose of 25 milligram rifalazil to be administered on Day 1. | Drug | Rifalazil 25 milligram |
| Azithromycin 1 gramAlso: ZithromaxSingle dose of Azithromycin 1 gram to be administered on Day 1. | Drug | Azithromycin 1 gram |
Primary outcome
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22
Time frame: Day 22
Microbiologic test result will be reported as positive or negative for chlamydia trachomatis.
3 secondary outcomes
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36.
Time frame: Day 36
Number of subjects experiencing adverse events in the two treatment groups.
Time frame: Day 36 (end of study)
Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups.
Time frame: Day 36 (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2013.
- Derived from this study: PubMed 24798277Geisler WM, Pascual ML, Mathew J, Koltun WD, Morgan F, Batteiger BE, Mayes A, Tao S, Hurwitz SJ, Sayada C, Schinazi RF. Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women. Antimicrob Agents Chemother. 2014 Jul;58(7):4014-9. doi: 10.1128/AAC.02521-14. Epub 2014 May 5.
Related trials for Chlamydia Trachomatis Infection
RecruitingPhase 1
Phase 1 Study of Chlamydia Trachomatis mRNA Vaccine in Adults.
Chlamydia Trachomatis Immunization
Not yet recruiting
Optimizing Antibiotic Prescription in STI Clinics Using Rapid POCT
Chlamydia Trachomatis Infection, Neisseria Gonorrhoeae Infection
Not yet recruiting
Outcomes From Point-of-Care Sexually Transmitted Infection (STI) Testing in an Urban Sexual Health Clinic: A Randomized Trial
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Recruiting
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
Chlamydia, Gonorrhea
Recruiting
Improving Maternal and Child Health Through Point-of-care STI Testing
Treponema Pallidum Infection, Chlamydia Trachomatis Infection
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.
Chalom B Sayada, MD, PhD study director
ActivBiotics Pharma
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rifalazil 25 milligram and Azithromycin 1 gram in people with Chlamydia Trachomatis Infection, run by ActivBiotics Pharma, LLC at 5 sites in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22 (time frame: Day 22). 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 NCT01631201, 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 29 Apr 2013.