Anal Chlamydia InfectionPhase 4NCT03608774
Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM
A Phase 4 study testing Azithromycin and Doxycycline in people with Anal Chlamydia Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial summary
A clinical trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Anal Chlamydia Infection
- What is being tested?
- Azithromycin and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jul 2018to 21 Feb 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to understand and provide written informed consent before initiation of any study procedures.
- Willing and able to comply with planned study procedures for all study visits.
- Male sex at birth and aged = / > 18 years with valid contact information.
- At least one male sex partner (oral or anal) in the past 12 months.
- Untreated rectal CT diagnosed by a positive NAAT result.
- Willingness to abstain from condomless receptive anal sex during the trial.
- Willingness to complete a 7-day study drug regimen.
Who cannot join
- Current clinical diagnosis of acute proctitis per the CDC's 2015 STD Treatment Guidelines: symptoms of anorectal pain, tenesmus, and/or rectal discharge with anoscopy findings confirming inflammation.
- Concomitant untreated gonorrhea (rectal, pharyngeal, or urethral) or known exposure to gonorrhea in the time between CT testing and study enrollment.
- Clinical diagnosis of concomitant untreated primary or secondary syphilis.
- Known allergy to tetracyclines or macrolides.
- Received antimicrobial therapy active against C. trachomatis within 21 days of positive rectal CT NAAT result, or between the positive CT NAAT result and study enrollment*.
- This includes subjects treated empirically on the day of testing due to known exposure to gonorrhea or chlamydia, as well as enrollment in another study using antimicrobial therapy active against C. trachomatis, or planned enrollment in such a study during their time in this trial. Specifically, use of the following antibiotics is an exclusion criterion: azithromycin and other macrolides, doxycycline and related tetra- or glycylcyclines, fluoroquinolones, rifampin, quinupristin-dalfopristin, and linezolid.
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- Plans to move to another location that would preclude study follow-up appointments in clinic or by mail-in in the next 30 days.
- Use of any investigational drug contraindicated to treatment with azithromycin or doxycycline within 7 days before enrollment.
- Previous enrollment in this trial.
- Any other condition that, in the opinion of the investigator, would interfere with participation in the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fenway Health - The Fenway Institute
Boston, Massachusetts, 02115
University of Washington - Harborview Medical Center - Center for AIDS and STD
Seattle, Washington, 98104-2499
About this study
Official title: A Phase 4, Randomized, Double-Blinded, Placebo-Controlled Trial of Azithromycin Versus Doxycycline for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men
A clinical trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). Subjects will be males aged = / > 18 years with a microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274 total subjects to achieve 246 subjects who contribute to the primary analysis. The duration of this study will be approximately 16 months 22 months with subject participation duration 29 days. The primary objective of this study is to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative NAAT) at Day 29.
Read the detailed description
A Phase 4, multi-center, randomized, double-blinded, placebo-controlled trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). The effect of Lymphogranuloma Venereum (LGV) infection on microbiologic cure in MSM with rectal CT will also be assessed. Arm 1 will comprise of subjects receiving 1 gram of Azithromycin (4 capsules of 250 mg) orally as a single dose, and Doxycycline placebo (1 capsule) orally twice daily for 7 days. Arm 2 will comprise of subjects receiving 100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days, and Azithromycin placebo (4 capsules) administered orally as a single dose. Subjects will be males aged = / >18 years with a microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274 total subjects to achieve 246 subjects who contribute to the primary analysis. The duration of this study will be approximately 22 months with subject participation duration 29 days. The primary objective of this study is to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative NAAT) at Day 29. The secondary objectives are: 1) to assess the effect of LGV infection on microbiologic cure in MSM with rectal CT at Days 15 and 29 and 2) to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT in MSM based on microbiologic cure at Day 15.
- Conditions
- Anal Chlamydia Infection
- Being tested
- Azithromycin, Doxycycline, Placebo
- Keywords
- Azithromycin, Doxycycline, Efficacy, MSM, Phase 4, Rectal Chlamydia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
DoxycyclineDrug
Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
PlaceboOther
Azithromycin placebo (4 capsules), administered orally as a single dose; Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=123 Receives: Drug: Azithromycin; Other: Placebo |
| Arm 2 | Experimental | 100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=123 Receives: Drug: Doxycycline; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 29
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure.
Measured: Day 29
Secondary outcomes (5)
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 15
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 15 is reported in this outcome measure.
Measured: Day 15
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 15 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Measured: Day 15
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Measured: Day 29
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 15 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Measured: Day 15
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure. LGV strains of CT were identified via multiplex PCR (Polymerase Chain Reaction) on positive CT NAAT specimens.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start13 Jul 2018
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal Chlamydia InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608774
- Sponsor's protocol ID
- 17-0092
- Status last verified
- 25 Jan 2019
- First submitted
- 28 Jun 2018
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dombrowski JC, Wierzbicki MR, Newman LM, Powell JA, Miller A, Dithmer D, Soge OO, Mayer KH. Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial. Clin Infect Dis. 2021 Sep 7;73(5):824-831. doi: 10.1093/cid/ciab153.
PubMed 33606009
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Randomized, Double-Blinded, Placebo-Controlled Trial of Azithromycin Versus Doxycycline for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT03608774
- Acronym / sponsor ID
- 17-0092
- Conditions
- Anal Chlamydia Infection
- Keywords
- Azithromycin, Doxycycline, Efficacy, MSM, Phase 4, Rectal Chlamydia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). Subjects will be males aged = / > 18 years with a microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274 total subjects to achieve 246 subjects who contribute to the primary analysis. The duration of this study will be approximately 16 months 22 months with subject participation duration 29 days. The primary objective of this study is to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative NAAT) at Day 29.
Detailed description
A Phase 4, multi-center, randomized, double-blinded, placebo-controlled trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2) administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men who have sex with men (MSM). The effect of Lymphogranuloma Venereum (LGV) infection on microbiologic cure in MSM with rectal CT will also be assessed. Arm 1 will comprise of subjects receiving 1 gram of Azithromycin (4 capsules of 250 mg) orally as a single dose, and Doxycycline placebo (1 capsule) orally twice daily for 7 days. Arm 2 will comprise of subjects receiving 100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days, and Azithromycin placebo (4 capsules) administered orally as a single dose. Subjects will be males aged = / >18 years with a microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274 total subjects to achieve 246 subjects who contribute to the primary analysis. The duration of this study will be approximately 22 months with subject participation duration 29 days. The primary objective of this study is to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative NAAT) at Day 29. The secondary objectives are: 1) to assess the effect of LGV infection on microbiologic cure in MSM with rectal CT at Days 15 and 29 and 2) to compare the efficacy of azithromycin vs. doxycycline for treatment of rectal CT in MSM based on microbiologic cure at Day 15.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Azithromycin, Other: Placebo1 gram of Azithromycin (4 capsules of 250 mg) administered orally as a single dose on Day 1, and Doxycycline placebo (1 capsule) administered orally twice daily for 7 days starting on Day 1. N=123 |
| Arm 2 | Experimental | Drug: Doxycycline, Other: Placebo100 mg of Doxycycline (1 capsule) administered orally twice daily for 7 days starting on Day 1, and Azithromycin placebo (4 capsules) administered orally as a single dose on Day 1. N=123 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to understand and provide written informed consent before initiation of any study procedures.
- Willing and able to comply with planned study procedures for all study visits.
- Male sex at birth and aged = / > 18 years with valid contact information.
- At least one male sex partner (oral or anal) in the past 12 months.
- Untreated rectal CT diagnosed by a positive NAAT result.
Key exclusion criteria (10 listed)
- Current clinical diagnosis of acute proctitis per the CDC's 2015 STD Treatment Guidelines: symptoms of anorectal pain, tenesmus, and/or rectal discharge with anoscopy findings confirming inflammation.
- Concomitant untreated gonorrhea (rectal, pharyngeal, or urethral) or known exposure to gonorrhea in the time between CT testing and study enrollment.
- Clinical diagnosis of concomitant untreated primary or secondary syphilis.
- Known allergy to tetracyclines or macrolides.
- Received antimicrobial therapy active against C. trachomatis within 21 days of positive rectal CT NAAT result, or between the positive CT NAAT result and study 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 |
|---|---|---|
| AzithromycinAzithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose. | Drug | Arm 1 |
| DoxycyclineDoxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days. | Drug | Arm 2 |
| PlaceboAzithromycin placebo (4 capsules), administered orally as a single dose; Doxycycline placebo (1 capsule), administered orally twice daily for 7 days. | Other | Arm 1, Arm 2 |
Primary outcome
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 29
Time frame: Day 29
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure.
5 secondary outcomes
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 15
Time frame: Day 15
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline
Time frame: Day 15
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline
Time frame: Day 29
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline
Time frame: Day 15
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline
Time frame: Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33606009Dombrowski JC, Wierzbicki MR, Newman LM, Powell JA, Miller A, Dithmer D, Soge OO, Mayer KH. Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial. Clin Infect Dis. 2021 Sep 7;73(5):824-831. doi: 10.1093/cid/ciab153.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin and Doxycycline in people with Anal Chlamydia Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 7 inclusion and 10 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 29 (time frame: Day 29). 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 NCT03608774, 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 7 Jan 2021.