Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 38 for:    Recruiting, Not yet recruiting, Available Studies | Chlamydia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03608774
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
Anal Chlamydia Infection Drug: Azithromycin Drug: Doxycycline Other: Placebo Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 26, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : October 31, 2020


Arm Intervention/treatment
Experimental: Arm 1
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
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.

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

Experimental: Arm 2
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
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.

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




Primary Outcome Measures :
  1. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 1 [ Time Frame: Day 29 ]
  2. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 2 [ Time Frame: Day 29 ]

Secondary Outcome Measures :
  1. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 1 within subgroups defined by LGV infection [ Time Frame: Day 29 ]
  2. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 1 [ Time Frame: Day 15 ]
  3. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 1 within subgroups defined by LGV infection [ Time Frame: Day 15 ]
  4. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 2 [ Time Frame: Day 15 ]
  5. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 2 within subgroups defined by LGV infection [ Time Frame: Day 15 ]
  6. The proportion of subjects with microbiologic cure (negative rectal Chlamydia trachomatis (CT) nucleic acid amplification test (NAAT) result) in Arm 2 within subgroups defined by LGV infection [ Time Frame: Day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing and able to understand and provide written informed consent before initiation of any study procedures.
  2. Willing and able to comply with planned study procedures for all study visits.
  3. Male sex at birth and aged = / > 18 years with valid contact information.
  4. At least one male sex partner (oral or anal) in the past 12 months.
  5. Untreated rectal CT diagnosed by a positive NAAT result.
  6. Willingness to abstain from condomless receptive anal sex during the trial.
  7. Willingness to complete a 7-day study drug regimen.

Exclusion Criteria:

  1. 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.
  2. Concomitant untreated gonorrhea (rectal, pharyngeal, or urethral) or known exposure to gonorrhea in the time between CT testing and study enrollment.
  3. Clinical diagnosis of concomitant untreated primary or secondary syphilis.
  4. Known allergy to tetracyclines or macrolides.
  5. 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.

  6. Plans to move to another location that would preclude study follow-up appointments in clinic or by mail-in in the next 30 days.
  7. Use of any investigational drug contraindicated to treatment with azithromycin or doxycycline within 7 days before enrollment.
  8. Previous enrollment in this trial.
  9. Any other condition that, in the opinion of the investigator, would interfere with participation in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608774


Contacts
Layout table for location contacts
Contact: Julia C. Dombrowski 12067445640 jdombrow@uw.edu

Locations
Layout table for location information
United States, Massachusetts
Fenway Health - The Fenway Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, Washington
University of Washington - Harborview Medical Center - Center for AIDS and STD Recruiting
Seattle, Washington, United States, 98104-2499
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03608774     History of Changes
Other Study ID Numbers: 17-0092
HHSN272201300012I
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: January 25, 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Azithromycin
Doxycycline
Efficacy
MSM
Phase 4
Rectal Chlamydia

Additional relevant MeSH terms:
Layout table for MeSH terms
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents