Status:
TERMINATED
Placebo-Controlled Trial of Antibiotic Therapy in Adults With Suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin Level
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Lower Respiratory Tract Infection
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This is a randomized, double-blinded, placebo-controlled, non-inferiority multicenter clinical trial of azithromycin vs. placebo in adults presenting as outpatients with suspect Lower Respiratory Trac...
Detailed Description
This is a randomized, double-blinded, placebo-controlled, non-inferiority multicenter clinical trial of azithromycin vs. placebo in adults presenting as outpatients with suspect Lower Respiratory Trac...
Eligibility Criteria
Inclusion
- Clinician suspected Lower Respiratory Tract Infection (LRTI)\* based on the presence of at least two qualifying symptoms\*\* OR one qualifying symptom and at least one qualifying vital sign\*\*\*.
- \*LRTI will include acute bronchitis, tracheitis, tracheobronchitis, asthma exacerbation, and acute exacerbation of Chronic obstructive pulmonary disease (COPD) but does not include known pneumonia.
- \*\*New cough, worsening of chronic cough, new sputum production, increased volume or purulence of chronic sputum production, chest pain, and difficulty breathing.
- \*\*\*Fever (Provider or patient-measured temperature \> / = 37.8 degrees Celsius (100.0 degrees Fahrenheit) or patient-reported feverishness), tachycardia of \> / = 90 beats/minute, tachypnea of \> 20 breaths/minute.
- Males and females age \> / = 18 years old.
- Presentation \> / = 24 hours and \< / = 28 days after the onset of at least one qualifying symptom related to the acute episode of illness.
- Ability to understand study procedures and willing and able to comply with all required procedures and visits for the entire length of study.
- Provide written informed consent before initiation of any study procedures.
Exclusion
- Hospitalized prior to screening and enrollment. Subjects enrolled in clinic or Emergency Department (ED) setting and then hospitalized during the same clinical encounter may be included.
- Chronic pulmonary conditions at the investigator's discretion\*.
- \*Such as:
- Noninvasive ventilation use for any indication other than obstructive sleep apnea
- Long-term invasive mechanical ventilation for any indication
- Known diagnosis of cystic fibrosis or chronic bronchiectasis.
- Receipt of an investigational product within 30 days prior to Day 1 or plans to potentially start any investigational product within 30 days after the subject's anticipated study completion.
- Current enrollment in another clinical trial of an investigational agent.
- Known or suspected infection at any other anatomic site requiring antibacterial therapy.
- Immunosuppression\*
- \*Includes:
- Human Immunodeficiency Virus (HIV) infection with CD4 \< 200 based on last known measurement or patient-reported value
- History of hematologic malignancies
- Receipt of chemotherapy within the previous 6 months or anticipated receipt of chemotherapy during the study period (1 month)
- Known to have an absolute neutrophil count of \< 500 cells/mL or an expectation of an absolute neutrophil count of \< 500 cells/mL during course of the study
- Current systemic corticosteroid use (equivalent of 20mg prednisone per day for \> / = 2 weeks within the last month)
- Systemic non-steroid immunosuppressive or biologic therapy for transplant, rheumatologic conditions, or other conditions within the last month. Biologics used specifically for control of moderate to severe asthma, including anti-IgE monoclonal antibody therapy (Xolair) or IL-5 monoclonal antibodies (Mepolizumab and Reslizumab) are allowed
- Contraindication to the use of azithromycin including history of allergy or intolerance to azithromycin or known prolonged QTc interval (\> 500 msec).
- Any condition that in the judgment of the referring provider or site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.
- Prior use of azithromycin in the past two weeks.
- Use of any systemic antibiotic in the previous 24 hours.
- Previous randomization in this trial.
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2020
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT03341273
Start Date
December 8 2017
End Date
August 15 2020
Last Update
June 28 2023
Active Locations (5)
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1
The Hope Clinic of Emory University
Atlanta, Georgia, United States, 30332
2
Atlanta VA Medical Center - Infectious Diseases Clinic
Decatur, Georgia, United States, 30033
3
Durham VA Medical Center
Durham, North Carolina, United States, 27705-3875
4
Duke Vaccine and Trials Unit
Durham, North Carolina, United States, 27708