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Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

Primary Purpose

Anal Chlamydia Infection

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Azithromycin

Doxycycline

Placebo

About this trial

This is an interventional treatment trial for Anal Chlamydia Infection focused on measuring Azithromycin, Doxycycline, Efficacy, MSM, Phase 4, Rectal Chlamydia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Fenway Health - The Fenway Institute
University of Washington - Harborview Medical Center - Center for AIDS and STD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 29

Secondary Outcome Measures

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at 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.

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.

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.

Full Information

NCT ID

NCT03608774

First Posted

June 28, 2018

Last Updated

December 10, 2020

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT03608774

Brief Title

Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 25, 2019

Overall Recruitment Status

Completed

Study Start Date

July 13, 2018 (Actual)

Primary Completion Date

February 21, 2020 (Actual)

Study Completion Date

February 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Chlamydia Infection

Keywords

Azithromycin, Doxycycline, Efficacy, MSM, Phase 4, Rectal Chlamydia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

177 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

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

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Azithromycin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Doxycycline

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Azithromycin placebo (4 capsules), administered orally as a single dose; Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.

Primary Outcome Measure Information:

Title

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 29

Description

Time Frame

Day 29

Secondary Outcome Measure Information:

Title

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) at Day 15

Description

Time Frame

Day 15

Title

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline

Description

Time Frame

Day 15

Title

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of Non-LGV (Lymphogranuloma Venereum) Infected at Baseline

Description

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.

Time Frame

Day 29

Title

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline

Description

Time Frame

Day 15

Title

The Proportion of Subjects With Microbiologic Cure (Negative Rectal CT NAAT Result) Within the Subgroup of LGV (Lymphogranuloma Venereum) Infected at Baseline

Description

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.

Time Frame

Day 29

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Facility Information:

Facility Name

Fenway Health - The Fenway Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

University of Washington - Harborview Medical Center - Center for AIDS and STD

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104-2499

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33606009

Citation

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.

Results Reference

derived

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Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

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