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

NCT03608774 | Completed Phase 4 Results

• 1 other identifier: 17-0092
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

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.

Conditions

Anal Chlamydia Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 29

Secondary Outcomes (5)

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

  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

  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

  Day 29

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

  Day 15

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

  Day 29

Study Arms (2)

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

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

Drug: Doxycycline; Other: Placebo

Interventions

Azithromycin DRUG

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.

Arm 1

Doxycycline DRUG

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.

Arm 2

Placebo OTHER

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

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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\*.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Fenway Health - The Fenway Institute

Boston, Massachusetts, 02115, United States

Location

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

Seattle, Washington, 98104-2499, United States

Location

Related Publications (1)

• 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.

  PMID: 33606009 DERIVED

MeSH Terms

Interventions

Azithromycin; Doxycycline

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Julia C. Dombrowski, MD, MPH
• Organization: University of Washington

jdombrow@uw.edu

206-744-5640

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: August 1, 2018
• Study Start: July 13, 2018
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: January 7, 2021
• Results First Posted: January 7, 2021

Record last verified: 2019-01-25

Locations

US (2)