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Aztreonam for Pharyngeal Gonorrhea

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867734
Recruitment Status : Completed
First Posted : March 8, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Lindley Barbee, University of Washington

Brief Summary:

The Centers for Disease Control and Prevention has identified antimicrobial-resistant (AMR) Neisseria gonorrhoeae (NG) as one of the nation's top three urgent AMR threats. Since the advent of antibiotics in the 1930s, NG has developed resistance to every first-line antibiotic. Parenteral third-generation cephalosporins are now the only class of drug with consistent efficacy against NG. New therapies are urgently needed. Although some novel antimicrobials are under development, reevaluating older drugs is another option for quickly identifying additional treatments for gonorrhea. We propose a demonstration study to test a single dose of aztreonam for the treatment of pharyngeal gonorrhea. We chose to focus on pharyngeal gonorrhea because these infections are common, play an important role in fostering gonococcal resistance, and are harder to eradicate than genital infections. Although aztreonam appears to be >98.6% efficacious for anogenital NG, its efficacy at the pharynx may be less. Only 8 cases of pharyngeal gonorrhea have been documented to be treated with aztreonam, but of those, only 5 (62.5%) were cured. The dose used in those studies was 1g of aztreonam. Most antibiotics have a lower efficacy at the pharynx than anogenital sites, which is likely due to drug pharmacokinetics, i.e. difficulty in penetrating pharyngeal tissue. Thus, in the proposed study, we plan to treat 50 subjects with untreated pharyngeal gonorrhea with 2g IM Aztreonam.

Objectives:

The proposed study aims to evaluate the efficacy of a single 2g intramuscular (IM) dose of aztreonam in the treatment of pharyngeal gonorrhea. Secondary objectives include documenting the efficacy stratified by minimal inhibitory concentration (MIC) compared with the previously document area under the curve (AUC) in order to estimate a pharmacodynamic criterion. We will also attempt to determine whether aztreonam monotherapy induces antimicrobial resistance among treatment failures. Lastly, we will evaluate the tolerability of 2g of IM aztreonam. The specific aims are:

  1. Determine the proportion of persons whose pharyngeal gonococcal infections are cured with a single dose of 2g aztreonam intramuscularly.
  2. Determine the proportion of persons with urethral and/or rectal gonorrhea whose infections are cured with a single dose of 2g aztreonam IM.
  3. Evaluate the tolerability of 2g IM of aztreonam .
  4. Estimate the best pharmacodynamics criterion (i.e. AUC/MIC ratio) for pharyngeal gonorrhea treated with aztreonam using previously published AUC for 2g aztreonam and NG isolate MIC.
  5. Among treatment failures, conduct exploratory analyses comparing pre- and post-treatment MIC for evidence of induced resistance.

Study Design: Prospective cohort

Study Population & Inclusion Criteria:

Persons diagnosed with pharyngeal gonorrhea or gonococcal urethritis who are undergoing pharyngeal gonorrhea testing, who are not yet treated.

Intervention: 2g IM aztreonam x 1

Primary Outcome: Negative gonorrhea culture 4-7 days (+/- 1 day) after treatment

Sample Size: 50 persons


Condition or disease Intervention/treatment Phase
Gonorrhea of Pharynx Gonorrhea Drug: Aztreonam Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Demonstration Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aztreonam for Pharyngeal Gonorrhea: A Demonstration Study
Actual Study Start Date : April 5, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gonorrhea
Drug Information available for: Aztreonam

Arm Intervention/treatment
Experimental: 2g Aztreonam
Subjects to receive 2g Aztreonam IM for the treatment of gonorrhea
Drug: Aztreonam
2g IM Aztreonam




Primary Outcome Measures :
  1. Treatment Efficacy of Pharyngeal Gonorrhea as defined as the proportion of study participants with positive pharyngeal gonorrhea culture at of enrollment whose test of cure pharyngeal culture is negative [ Time Frame: 4-7 days following treatment ]
    Negative Test of Cure (i.e. Pharyngeal Gonorrhea Culture) after Treatment


Secondary Outcome Measures :
  1. Treatment Efficacy of Urethral Gonorrhea as defined as The proportion of study participants with gonococcal urethritis at enrollment whose test of cure urethral culture is negative [ Time Frame: 4-7 days following treatment ]
    Negative Test of Cure (I.e. Urethral gonorrhea Culture) after treatment

  2. Treatment Efficacy of Rectal Gonorrhea as defined as The proportion of study participants with positive rectal culture at enrollment whose test of cure rectal culture is negative [ Time Frame: 4-7 days following treatment ]
    Negative Test of Cure (i.e. Rectal gonorrhea culture) after treatment

  3. Tolerability of 2g Aztreonam IM [ Time Frame: Immediately following injection and 4-7 days following injection ]
    Subjects' self-report of injection related pain on a scale from 0 - 10

  4. Side Effects of 2g Aztreonam IM [ Time Frame: assessed immediately following injection and 4-7 days after injection ]
    Subject's report of perceived side effects related to study drug based on responses to standard side effect questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Persons diagnosed with pharyngeal gonorrhea or gonococcal urethritis who are undergoing pharyngeal gonorrhea testing, who are not yet treated.

Exclusion Criteria:

  • Age less than 16 years
  • Receipt of antibiotics in ≤30 days
  • Known allergy to aztreonam
  • History of renal disease (including diagnosis of solitary kidney, chronic renal insufficiency, renal cell carcinoma etc.)
  • Concurrent infection with syphilis or chlamydia
  • Pregnancy and/or nursing
  • Unable to return for a follow-up visit 4-7 days (+/- 1 day).
  • Study team's discretion

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): NCT03867734


Locations
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United States, Washington
Public Health -- Seattle & King County STD Clinic
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Lindley Barbee, MD, MPH University of Washington

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Responsible Party: Lindley Barbee, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03867734    
Other Study ID Numbers: STUDY00003878-02
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lindley Barbee, University of Washington:
aztreonam
treatment study
Additional relevant MeSH terms:
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Gonorrhea
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Aztreonam
Anti-Bacterial Agents
Anti-Infective Agents